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Prasugrel

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Prasugrel does in the body

Preventing clots after a stent is placed for a heart attack or unstable angina

Platelets shout to each other using a chemical called ADP, and that shouting is what turns a handful of sticky platelets into a clot big enough to block an artery. Prasugrel is inactive when you swallow it; enzymes in the gut and liver convert it in two quick steps into a compound that permanently locks the receptor platelets use to hear ADP. Permanently means for that platelet’s entire life — about a week — so the effect only wears off as your bone marrow replaces them. Clopidogrel works the same way but is converted far less efficiently, which is why prasugrel acts faster and harder.

What happened in people

Cardiovascular death, myocardial infarction or stroke 9.9% against 12.1% on clopidogrel in 13,608 stented patients, hazard ratio 0.81

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

The only P2Y12 inhibitor to have won both of its head-to-head randomised trials, against clopidogrel and against ticagrelor

Where it acts
The surface membrane of circulating platelets, and through them the freshly stented coronary artery
Kind of result
Living longer, or avoiding a major event
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · G89JQ59I13 · read 2026-08-29

  • Its recorded molecular formula is C20H20FNO3S•HCl, weighing 409.90.

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 141 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Absolute difference

An absolute difference is how many more people in a hundred were affected.

A picture of it, and where the picture fails

It is like counting heads in two rooms of a hundred.

Where that stops being true. Heads are easy to count. Study results carry a margin of error too.

What people get wrong. It is confused with a percentage change, which can look far larger.

The arithmetic difference in event rates between arms.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Cardiovascular death, nonfatal myocardial infarction or nonfatal stroke, prasugrel versus clopidogrel in acute coronary syndrome with scheduled percutaneous coronary intervention

The study showed what it set out to show

Who was studied
TRITON-TIMI 38 (NCT00097591)
How many people
13608
Study design
Phase 3 randomised double-blind trial, 6 to 15 months of treatment
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
9.9% vs 12.1%, hazard ratio 0.81 (95% CI 0.73 to 0.90), p<0.001. Stent thrombosis 1.1% vs 2.4%, p<0.001
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. TIMI major bleeding 2.4% vs 1.8% (p=0.03), life-threatening bleeding 1.4% vs 0.9% (p=0.01), fatal bleeding 0.4% vs 0.1% (p=0.002). Overall mortality did not differ. Patients with prior transient ischaemic attack or stroke had a stroke rate of 6.5% vs 1.2%.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, a single loading dose followed by once-daily maintenance, with aspirin

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Cardiovascular death, myocardial infarction or stroke in patients under 75 with acute coronary syndrome managed without revascularisation, prasugrel versus clopidogrel

The study did not show it

Who was studied
TRILOGY ACS (NCT00699998)
How many people
9326
Study design
Phase 3 randomised double-blind trial, up to 30 months of treatment
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
13.9% vs 16.0% at median 17 months, hazard ratio 0.91 (95% CI 0.79 to 1.05), p=0.21 — not met
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Severe and intracranial bleeding rates were similar in all age strata, so the ischaemic-versus-bleeding trade that justifies prasugrel elsewhere was absent in both directions. A prespecified recurrent-events analysis (hazard ratio 0.85, p=0.04) is a secondary result reported after the primary failed.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, a single loading dose followed by once-daily maintenance, with aspirin

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Composite of cardiovascular death, myocardial infarction, stroke, urgent revascularisation or glycoprotein IIb/IIIa bailout through day 7, prasugrel before angiography versus at the time of intervention

The study did not show it

Who was studied
ACCOAST (NCT01015287)
How many people
4033
Study design
Phase 3 randomised double-blind trial, stopped early, 7-day primary endpoint
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Hazard ratio 1.02 (95% CI 0.84 to 1.25), p=0.81 — no difference. TIMI major bleeding hazard ratio 1.90 (95% CI 1.19 to 3.02), p=0.006
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. TIMI major bleeding and life-threatening non-bypass bleeding were increased threefold and sixfold respectively. No benefit even in the 69% who underwent intervention. Results confirmed at 30 days and in prespecified subgroups.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, a single loading dose followed by once-daily maintenance, with aspirin

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Composite of death, myocardial infarction or stroke at one year, ticagrelor versus prasugrel in acute coronary syndrome with planned invasive evaluation

The study showed what it set out to show

Who was studied
ISAR-REACT 5 (NCT01944800)
How many people
4018
Study design
Phase 4 multicentre randomised open-label trial, one-year endpoint
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
9.3% (184/2012) ticagrelor vs 6.9% (137/2006) prasugrel, hazard ratio 1.36 (95% CI 1.09 to 1.70), p=0.006 — favouring prasugrel
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Open-label design, and the two drugs were administered on different schedules relative to angiography, so the comparison is between treatment strategies as well as between molecules. BARC major bleeding 5.4% vs 4.8%, p=0.46.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, a single loading dose followed by once-daily maintenance, with aspirin

Interval reported. 95% CI 1

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Prasugrel

    What a person takes: Oral tablet, a single loading dose followed by once-daily maintenance, with aspirin.

    The measurement behind this step

    Film-coated tablets taken once daily after an initial loading dose, always alongside aspirin — every patient in every trial on this page received both. The active metabolite reaches peak concentration in roughly 30 minutes, faster than clopidogrel, and the block on each platelet is permanent, so the effect accumulates over the first days and fades only as the marrow makes new platelets over 7 to 10 days.

  2. Getting in

    A tablet that is completely inactive when you swallow it

    What you take does nothing at all to platelets. It has to be chemically converted twice before anything happens.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Prasugrel hydrochloride, 373.40 g/mol as the free base, given as a loading dose followed by a daily maintenance dose alongside aspirin. The parent compound has no measurable affinity for P2Y12. Peak active metabolite concentration is reached in about 30 minutes, considerably faster than clopidogrel.

  3. Reaching the cell

    The gut wall makes the first cut, the liver makes the second

    An enzyme in the intestinal lining opens the molecule up, then a liver enzyme finishes the job. Only after both does the working compound exist.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Intestinal carboxylesterases hydrolyse the enol acetate to a thiolactone, which is then oxidised in a single cytochrome P450 step — principally CYP3A4 and CYP2B6, with CYP2C9 and CYP2C19 contributing — to the active thiol R-138727. Because no single enzyme is rate-limiting, CYP2C19 loss-of-function alleles do not blunt the effect as they do with clopidogrel.

  4. What it acts on

    It welds itself onto the platelet receptor, permanently

    The active compound forms a chemical bond with the receptor platelets use to hear each other. That bond does not come undone.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    R-138727 forms a disulphide bond with cysteine residues on the extracellular domain of the P2Y12 receptor. Binding is covalent and irreversible for the life of that platelet; there is no dissociation, and no dose reduction restores function.

  5. The change it makes

    The amplification loop between platelets is broken

    Platelets recruit each other by releasing ADP. With the receiver blocked, the message stops spreading and the plug stops growing.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    P2Y12 is a Gi-coupled receptor; blocking it prevents inhibition of adenylyl cyclase, keeps cyclic AMP high, sustains VASP phosphorylation and prevents the sustained conformational activation of glycoprotein IIb/IIIa that binds fibrinogen. Aspirin blocks the parallel thromboxane A2 loop, which is why the two are given together and why the combination bleeds more than either alone.

  6. What that does for a person

    Fewer stent clots, more fatal bleeds, and a week to wear off

    Half as many clots inside the stent, and four times as many bleeds that kill. Because the block is permanent, it only fades as new platelets are made, over about a week.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    TRITON-TIMI 38: cardiovascular death, myocardial infarction or stroke 9.9% against 12.1%; stent thrombosis 1.1% against 2.4%; TIMI major bleeding 2.4% against 1.8%; fatal bleeding 0.4% against 0.1%; overall mortality unchanged. Platelet function recovers only through marrow production of new platelets over 7 to 10 days, which is why the label directs discontinuation at least 7 days before surgery where possible.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Patients having a stent placed for an acute coronary syndrome. The label excludes anyone with a previous stroke or transient ischaemic attack outright, and generally advises against use over the age of 75.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness in pediatric patients have not been established.”

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-30

  • On older people, the label states: “In TRITON-TIMI 38, 38.5% of patients were ≥65 years of age and 13.2% were ≥75 years of age.”

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no data with prasugrel use in pregnant women to inform a drug-associated risk.”

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B).”

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dosage adjustment is necessary for patients with renal impairment.”

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-30

Where the result stopped carrying

  • Fatal bleeding, four times higher than clopidogrel, with no mortality gain to offset it
  • The prior stroke and transient ischaemic attack population, where stroke rose from 1.2% to 6.5% and which is now an outright contraindication
  • TRILOGY ACS, in 9,326 medically managed patients, p=0.21
  • ACCOAST, stopped early after pretreatment tripled major bleeding while changing nothing ischaemic
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral tablet, a single loading dose followed by once-daily maintenance, with aspirin

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

Film-coated tablets taken once daily after an initial loading dose, always alongside aspirin — every patient in every trial on this page received both.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold. The rest of the recorded wording: The active metabolite reaches peak concentration in roughly 30 minutes, faster than clopidogrel, and the block on each platelet is permanent, so the effect accumulates over the first days and fades only as the marrow makes new platelets over 7 to 10 days.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

The United States label carries a boxed warning for bleeding risk. Prasugrel is contraindicated in active pathological bleeding and in any history of transient ischaemic attack or stroke, and is generally not recommended above age 75 except in high-risk situations such as diabetes or prior myocardial infarction. It should not be started in patients likely to need urgent bypass surgery, and where possible should be stopped at least 7 days before any surgery. Named additional bleeding risk factors are body weight below 60 kg, a propensity to bleed, and concomitant warfarin, heparin, fibrinolytics or chronic non-steroidal anti-inflammatory drugs. Stopping it in the first weeks after an acute coronary syndrome increases the risk of further cardiovascular events, so discontinuation is itself a hazard.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral tablet, a single loading dose followed by once-daily maintenance, with aspirin

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

A recorded note compares this form with the others that are sold. It is kept below, word for word.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

The recorded note, unchanged: The active metabolite reaches peak concentration in roughly 30 minutes, faster than clopidogrel, and the block on each platelet is permanent, so the effect accumulates over the first days and fades only as the marrow makes new platelets over 7 to 10 days.

No source is stored against this line.

What is recorded as being sold

  • 31 products list this as an active ingredient in the United States drug directory. 31 of them contain it and nothing else.

    FDA National Drug Code directory · 0713-0881 · read 2026-08-29

  • They are sold as powder, tablet, coated and tablet, film coated, taken oral.

    FDA National Drug Code directory · 0713-0881 · read 2026-08-29

  • The regulator's established pharmacologic class for it is decreased platelet aggregation [pe], p2y12 platelet inhibitor [epc] and p2y12 receptor antagonists [moa].

    FDA National Drug Code directory · 0713-0881 · read 2026-08-29

  • 11 published labels name it as an active ingredient. 11 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-29

  • Prasugrel is oral at 3 DOSAGE FORMS AND STRENGTHS Prasugrel tablets 5 mg is available as a yellow, elongated hexagonal, film coated non scored tablet, debossed with “AA1” on one side and “plain” on other side., recorded as fda label in effect 2024-01-05 in the United States.

    US prescribing information · cd6bf899-06b7-4f52-96c5-ffc94a7288ff · read 2026-08-30

  • Recorded price in US: 0.26156–0.26161 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 13 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Prasugrel studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That prasugrel saves lives — the ischaemic composite fell, fatal bleeding rose fourfold, and overall mortality did not differ

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the benefit extends to patients managed without a stent — TRILOGY ACS tested exactly that and missed at p=0.21

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That earlier administration produces earlier benefit — ACCOAST found a hazard ratio of 1.02 for ischaemia and 1.90 for major bleeding

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the recurrent-events analysis in TRILOGY ACS rescues the result — it is a secondary analysis reported after the primary endpoint failed

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That genotype-independent activation is a benefit separable from the bleeding — the same stronger blockade produces both

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Prasugrel are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

TRITON-TIMI 38: stent thrombosis more than halved against clopidogrel
In plain words
In 13,608 patients having a stent placed, prasugrel prevented about half the clots that formed inside the stent and about a quarter of the repeat heart attacks that clopidogrel allowed.
What was measured
Cardiovascular death, nonfatal myocardial infarction or nonfatal stroke over 6 to 15 months, and stent thrombosis 1.1% against 2.4%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
TRITON-TIMI 38 (NCT00097591) randomised 13,608 patients with moderate-to-high-risk acute coronary syndromes and scheduled percutaneous coronary intervention to prasugrel or clopidogrel for 6 to 15 months, all on aspirin. The primary endpoint of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke occurred in 12.1% on clopidogrel against 9.9% on prasugrel, hazard ratio 0.81 (95% CI 0.73 to 0.90, p<0.001). Myocardial infarction was 9.7% against 7.4% (p<0.001), urgent target-vessel revascularisation 3.7% against 2.5% (p<0.001), and stent thrombosis 2.4% against 1.1% (p<0.001). The stent thrombosis figure is the cleanest single result prasugrel has, and it is mechanistically coherent: a drug that produces faster and more complete P2Y12 blockade should prevent more clots on a fresh stent, and it did.
Source
Wiviott SD et al., N Engl J Med 2007;357:2001-2015 (TRITON-TIMI 38, NCT00097591)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Fatal bleeding was four times higher, and overall mortality did not move
In plain words
The same trial that showed fewer clots showed more people bleeding to death — 0.4% against 0.1%. The total number of deaths from all causes was the same in both groups.
What was measured
Fatal bleeding 0.4% against 0.1% (p=0.002), life-threatening bleeding 1.4% against 0.9%, and all-cause mortality with no significant difference
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In TRITON-TIMI 38, TIMI major bleeding not related to bypass surgery occurred in 2.4% of prasugrel patients against 1.8% on clopidogrel, hazard ratio 1.32 (95% CI 1.03 to 1.68, p=0.03). Life-threatening bleeding was 1.4% against 0.9% (p=0.01), comprising nonfatal bleeding 1.1% against 0.9% (hazard ratio 1.25, p=0.23) and fatal bleeding 0.4% against 0.1% (p=0.002) — a fourfold relative increase in the one bleeding outcome that cannot be recovered from. The published conclusion records the arithmetic that follows: "Overall mortality did not differ significantly between treatment groups." A drug that prevents 22 ischaemic events per thousand and causes 3 additional fatal bleeds per thousand is a net gain by most reasonable weighting, and the fact that all-cause mortality did not move is the boundary of what that gain amounts to.
Source
Wiviott SD et al., N Engl J Med 2007;357:2001-2015 (TRITON-TIMI 38)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
A fivefold excess of stroke in patients who had already had one
In plain words
Among patients with a past stroke or mini-stroke, 6.5% had a stroke on prasugrel against 1.2% on clopidogrel. This is now written into the label as an outright contraindication.
What was measured
Stroke rate in patients with prior transient ischaemic attack or stroke: 6.5% on prasugrel against 1.2% on clopidogrel
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The United States label reports the subgroup directly. In TRITON-TIMI 38, patients with a history of transient ischaemic attack or ischaemic stroke more than three months before enrolment had a stroke rate of 6.5% on prasugrel — 4.2% thrombotic and 2.3% intracranial haemorrhage — against 1.2% on clopidogrel, all of which were thrombotic. In patients without that history the rates were 0.9% on prasugrel (0.2% intracranial haemorrhage) and 1.0% on clopidogrel (0.3%). Patients with an ischaemic stroke within three months, or any prior haemorrhagic stroke, were excluded from the trial altogether, so the excess was found in the least severe subgroup that was allowed in. Prior transient ischaemic attack or stroke is a contraindication in section 4.2 and appears in the boxed warning. This is what a subgroup finding looks like when it is large, mechanistically plausible, and confined to a group identifiable by a single question — and it is the reason the boxed warning also generally advises against use above age 75 and names body weight below 60 kg as a risk factor.
Source
Prasugrel tablets, United States prescribing information, boxed warning and section 4.2; Wiviott SD et al., N Engl J Med 2007;357:2001-2015
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
TRILOGY ACS: no benefit in the patients who do not get a stent
In plain words
In 9,326 patients with a heart attack managed with drugs rather than a stent, prasugrel did not reduce the main outcome. Bleeding was similar, so the trade that justifies it elsewhere was not available either.
What was measured
Cardiovascular death, myocardial infarction or stroke in medically managed acute coronary syndrome, 13.9% against 16.0%, p=0.21
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
TRILOGY ACS (NCT00699998) randomised patients with unstable angina or non-ST-elevation myocardial infarction who did not undergo revascularisation, comparing up to 30 months of prasugrel with clopidogrel, all on aspirin. In the primary analysis population of 7,243 patients under 75, cardiovascular death, myocardial infarction or stroke occurred in 13.9% on prasugrel against 16.0% on clopidogrel at a median 17 months — hazard ratio 0.91 (95% CI 0.79 to 1.05, p=0.21). The endpoint was not met, and similar results were seen in the overall population including the 2,083 patients aged 75 or over who received a reduced dose. Rates of severe and intracranial bleeding were similar in both groups in all age strata. A prespecified analysis of multiple recurrent ischaemic events suggested lower risk with prasugrel (hazard ratio 0.85, 95% CI 0.72 to 1.00, p=0.04); that is a secondary analysis reported after the primary endpoint failed, and it is the kind of result that becomes a claim if the failure above it is not quoted alongside.
Source
Roe MT et al., N Engl J Med 2012;367:1297-1309 (TRILOGY ACS, NCT00699998)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
ACCOAST: giving it earlier tripled major bleeding and prevented nothing
In plain words
A trial tested whether starting prasugrel before the angiogram rather than after would help. It did not change outcomes at all, and tripled the rate of serious bleeding.
What was measured
Composite ischaemic endpoint through day 7 (hazard ratio 1.02) and TIMI major bleeding (hazard ratio 1.90) with pretreatment before angiography
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ACCOAST (NCT01015287) enrolled 4,033 patients with non-ST-elevation acute coronary syndrome and a positive troponin, scheduled for angiography within 2 to 48 hours, randomised to a 30 mg prasugrel loading dose before angiography or to placebo, with the remainder of the loading dose given at the time of intervention in both arms. The primary composite of cardiovascular death, myocardial infarction, stroke, urgent revascularisation or glycoprotein IIb/IIIa bailout through day 7 gave a hazard ratio of 1.02 (95% CI 0.84 to 1.25, p=0.81) — no difference whatsoever. TIMI major bleeding through day 7 was increased with pretreatment, hazard ratio 1.90 (95% CI 1.19 to 3.02, p=0.006), and the publication states that TIMI major bleeding and life-threatening bleeding not related to bypass surgery "were increased by a factor of 3 and 6, respectively". Pretreatment did not reduce the primary outcome even among the 69% who went on to intervention. All results held at 30 days and in prespecified subgroups. The trial was stopped early. This is as clean a negative as the field produces: a plausible timing hypothesis, tested, with all of the harm and none of the benefit.
Source
Montalescot G et al., N Engl J Med 2013;369:999-1010 (ACCOAST, NCT01015287)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
ISAR-REACT 5: it beat ticagrelor head to head, which nothing else has
In plain words
In 4,018 patients randomised between the two strongest platelet drugs, prasugrel prevented more deaths, heart attacks and strokes than ticagrelor, with no more bleeding.
What was measured
Death, myocardial infarction or stroke at one year, 6.9% on prasugrel against 9.3% on ticagrelor, with major bleeding 4.8% against 5.4%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ISAR-REACT 5 (NCT01944800) was a multicentre randomised open-label trial in 4,018 patients presenting with acute coronary syndromes for whom invasive evaluation was planned. The primary composite of death, myocardial infarction or stroke at one year occurred in 184 of 2,012 ticagrelor patients (9.3%) against 137 of 2,006 prasugrel patients (6.9%) — hazard ratio 1.36 (95% CI 1.09 to 1.70, p=0.006), favouring prasugrel. Components: death 4.5% against 3.7%, myocardial infarction 4.8% against 3.0%, stroke 1.1% against 1.0%. Definite or probable stent thrombosis 1.3% against 1.0%, definite stent thrombosis 1.1% against 0.6%. BARC major bleeding was 5.4% against 4.8%, hazard ratio 1.12 (95% CI 0.83 to 1.51, p=0.46). Two design features belong beside the result: the trial was open label, and the two drugs were given on different schedules — ticagrelor before angiography, prasugrel mostly after — which mirrors the practice each is licensed for and also means the comparison is between strategies as well as between molecules.
Source
Schüpke S et al., N Engl J Med 2019;381:1524-1534 (ISAR-REACT 5, NCT01944800)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Its activation does not hinge on CYP2C19, which is the real difference from clopidogrel
In plain words
Clopidogrel has to be switched on by a liver enzyme that a large minority of people carry a weak version of. Prasugrel does not depend on that enzyme in the same way, so it works consistently.
What was measured
Formation of the active thiol metabolite R-138727 through a single cytochrome P450 oxidation not rate-limited by CYP2C19
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Clopidogrel requires two sequential cytochrome P450 oxidations, both substantially dependent on CYP2C19, and roughly 2% of white and 14% of Chinese populations are poor metabolisers with markedly reduced active metabolite formation. Prasugrel is hydrolysed first by intestinal carboxylesterases to a thiolactone and then oxidised in a single step carried by CYP3A4 and CYP2B6 with contributions from CYP2C9 and CYP2C19, so no single genotype is rate-limiting. The measured consequence is faster and more complete inhibition of ADP-induced platelet aggregation with much less between-person variability. What is worth stating precisely is what this explains and what it does not: it accounts for the ischaemic advantage in TRITON-TIMI 38 and equally for the bleeding disadvantage, because both follow from the same stronger blockade. It is not a separate benefit; it is the mechanism of the trade.
Source
Prasugrel tablets, United States prescribing information, section 12 Clinical Pharmacology; Wiviott SD et al., N Engl J Med 2007;357:2001-2015
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 11 documents were read for this substance.

    RNAWiki source record

  • 11 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 11 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
G89JQ59I13
RxNorm concept
855812

Checks this page had to pass

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  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

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  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 11 approved applications cover products containing this substance. The earliest was NDA022307, approved 20090710 to COSETTE.

    Drugs@FDA application register · NDA022307 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA022307 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20090710.

    FDA National Drug Code directory · 0713-0881 · read 2026-08-29

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What to learn next

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What is not here

7 questions this page could not answer

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Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

An irreversible platelet blocker that cut cardiovascular death, heart attack or stroke from 12.1% to 9.9% and stent thrombosis from 2.4% to 1.1% against clopidogrel in 13,608 patients — while raising fatal bleeding from 0.1% to 0.4%, leaving overall mortality unchanged, and causing a fivefold excess of stroke in patients with a previous stroke, which is now a contraindication.

Recorded evidence blocks (11)

On the Prasugrel label: indicated for what?


"Prasugrel tablets is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation…": indications and usage on Prasugrel's label. DailyMed label · f51e64e0-f556-65d0-a876-fb709aaeefea · 2026-04-08

146 registered trials of Prasugrel — at which phases?


Registered studies posting no result
93 of 146

146 registered studies of Prasugrel: 68 phase4, 35 phase3, 19 phase2, 12 phase1, 9 na, 6 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

449 with a PubMed record

Show the evidence
  • phase4
    68
  • phase3
    35
  • phase2
    19
  • phase1
    12
  • na
    9
  • na or unstated
    6
6 more recorded rows
  • completed
    105
  • unknown
    18
  • terminated
    10
  • recruiting
    8
  • withdrawn
    3
  • not yet recruiting
    2

recorded 2026-09-01 · last checked 2026-09-04

13 of Prasugrel's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?


safety (1), futility/efficacy (2), accrual/recruitment (3), funding/business (1) and other (6): Prasugrel's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Due to the low rate of primary endpoint events experienced in the study to date"; 13 of 146 registered studies

Show the evidence

Trial

  • NCT00910299
    terminated; "Due to the low rate of primary endpoint events experienced in the study to date"
  • NCT01107899
    terminated; "Terminated due to Enrollment futility"
  • NCT01339026
    terminated; "Change in guidelines favouring newer antiplatelet drugs in ACS"
  • NCT01452152
    terminated; "Terminated by study sponsor."
  • NCT01612884
    terminated; "Slow enrollment"
  • NCT01794000
    terminated; "The study is being terminated for lack of efficacy."
7 further recorded trials
  • NCT02075125
    terminated; "Enrolling participants has halted prematurely and will not resume"
  • NCT02302508
    withdrawn; "Funding"
  • NCT02507323
    withdrawn; "collaborator withdrew the study"
  • NCT02548611
    terminated; "Due to low recruitment"
  • NCT03027934
    withdrawn; "Study population difficult to recruit"
  • NCT03054207
    terminated; "difficulty to recruit"
  • NCT04100135
    terminated; "Dissatisfactory enrollment rate with no safety concerns"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Prasugrel used prasugrel 10 mg — over how long?


studies of Prasugrel used the recorded amount. ClinicalTrials.gov · 2026-09-01

18 recorded entries; human; tablet, per os; also "prasugrel 10 mg", "prasugrel 60 mg", "Prasugrel 10 mg"

Show the evidence

human

  • NCT00356135
    prasugrel 10 mg
  • NCT00356135
    prasugrel 60 mg
  • NCT01135667
    Prasugrel 10 mg
  • NCT02016170
    Prasugrel 10mg
  • NCT02070159
    Prasugrel 30 mg
  • NCT02070159
    Effient 30 mg
12 more recorded rows
  • human NCT02070159
    Prasugrel 60 mg
  • human NCT02070159
    Effient 60 mg
  • human NCT02075268
    tablet; Effient 10 mg tablet will be used as study drug.
  • human NCT02193971
    Prasugrel 5mg
  • human NCT02285751
    per os; 60mg prasugrel per os loading dose
  • human NCT02285751
    per os; 10mg prasugrel per os daily
  • human NCT02944123
    Prasugrel 5 mg
  • human NCT02944123
    Effient 5 mg
  • human NCT03054207
    Prasugrel 60Mg
  • human NCT03296540
    6 Crushed tablets of Prasugrel 10mg
  • human NCT03296540
    6 Integral tablets of Prasugrel 10mg
  • human NCT04445623
    Prasugrel Hydrochloride 10 MG Oral Tablet

recorded 2026-09-01 · last checked 2026-09-04

Prasugrel's half-life is 7 hours — which schedules were studied?


7 hours, the half-life Prasugrel's label states: "The active metabolite has an elimination half-life of about 7 hours (range 2-15 hours)." DailyMed label · f51e64e0-f556-65d0-a876-fb709aaeefea · 2026-04-08

tmax 30 minutes.

Show the evidence
  • half life pharmacokinetics
    7 hours; The active metabolite has an elimination half-life of about 7 hours (range 2-15 hours).
  • tmax pharmacokinetics
    30 minutes; The absorption and metabolism are rapid, with peak plasma concentrations (C max ) of the active metabolite occurring approximately 30 minutes after dosing.
  • metabolism pharmacokinetics
    Prasugrel is a prodrug and is rapidly metabolized to a pharmacologically active metabolite and inactive metabolites.

recorded 2026-04-08 · last checked 2026-09-04

Which running trial of Prasugrel could settle lifespan?


NCT02735707 measures All-cause mortality, reading out 2028-02.

1 open trial; n 20000; "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"

Show the evidence
  • Trial NCT02735707
    "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"; n 20000; "All-cause mortality"; 2028-02

Which 58 trials of Prasugrel posted no result?


Posted no result
58 of 58 completed trials
Registrations
NCT01109784, NCT01155765, NCT01099566, NCT01304472, NCT01184300 and NCT01338909, and 52 more
Completion dates
oldest 2010-07; newest 2024-01
Show the evidence

Trial

  • NCT01109784
    2010-07
  • NCT01155765
    2010-07
  • NCT01099566
    2010-11
  • NCT01304472
    2011-04
  • NCT01184300
    2011-07
  • NCT01338909
    2011-09
14 further recorded trials
  • NCT01346800
    2011-09
  • NCT01305369
    2011-12
  • NCT01360437
    2011-12
  • NCT01465828
    2012-01
  • NCT01463163
    2012-04
  • NCT01505790
    2012-05
  • NCT01336348
    2012-06
  • NCT01175200
    2012-07
  • NCT01463150
    2012-07
  • NCT01135667
    2012-08
  • NCT01642940
    2012-09
  • NCT01642966
    2012-09
  • NCT01510171
    2013-01
  • NCT02070159
    2013-01

At the median, Prasugrel's trials enrolled 77.5 people — anything larger?


Median enrolment
77.5
Largest enrolment
377753
Registered trials counted
146

What do 251 spontaneous reports say about Prasugrel — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Prasugrel appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 251 reaction mentions were counted: anaemia 33; vascular stent thrombosis 33; gastrointestinal haemorrhage 30; haemorrhage 30. FAERS via Open Targets · CHEMBL1201772 · 2026-06-24

Show the evidence
  • anaemia
    33
  • vascular stent thrombosis
    33
  • gastrointestinal haemorrhage
    30
  • haemorrhage
    30
  • epistaxis
    26
  • vascular pseudoaneurysm
    21
4 more recorded rows
  • acute myocardial infarction
    20
  • haematoma
    20
  • myocardial infarction
    20
  • angina unstable
    18

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Prasugrel's label not list?


acute myocardial infarction, anaemia and angina unstable and 7 more reported for Prasugrel, absent from its label. FAERS via Open Targets · CHEMBL1201772 · 2026-06-24

2 label terms; 10 reported and unlisted; f51e64e0-f556-65d0-a876-fb709aaeefea

Show the evidence
  • acute myocardial infarction
    count not stated
  • anaemia
    count not stated
  • angina unstable
    count not stated
  • epistaxis
    count not stated
  • gastrointestinal haemorrhage
    count not stated
  • haematoma
    count not stated
4 more recorded rows
  • haemorrhage
    count not stated
  • myocardial infarction
    count not stated
  • vascular pseudoaneurysm
    count not stated
  • vascular stent thrombosis
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Prasugrel and CYP3A, CYP2B6 and CYP2C9: shared by which compounds?


CYP3A, CYP2B6 and CYP2C9 appear in Prasugrel's recorded interaction sentences, 8 in all. DailyMed label · f51e64e0-f556-65d0-a876-fb709aaeefea · 2026-04-08

CYP1A2, CYP2B6, CYP2B6, CYP2C19, CYP2C19, CYP2C8; 14 shared nodes; drug_interactions, pharmacokinetics

Show the evidence

Interaction statement

  • drug_interactions
    Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of morphine or other opioid agonists 7.4 Other Concomitant Medications Prasugrel tablets can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes [see Clinical Pharmacology ( 12.3 )].
  • pharmacokinetics
    It is rapidly hydrolyzed in the intestine to a thiolactone, which is then converted to the active metabolite by a single step, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 and CYP2C19.
  • pharmacokinetics
    Drug Interaction Studies Potential for Other Drugs to Affect Prasugrel Inhibitors of CYP3A - Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the active metabolite's AUC and T max , but decreased the C max by 34% to 46%.
  • pharmacokinetics
    Therefore, CYP3A inhibitors such as verapamil, diltiazem, indinavir, ciprofloxacin, clarithromycin, and grapefruit juice are not expected to have a significant effect on the pharmacokinetics of the active metabolite of prasugrel [see Drug Interactions ( 7.4 )] .
  • pharmacokinetics
    Inducers of Cytochromes P450 - Rifampicin (600 mg daily), a potent inducer of CYP3A and CYP2B6 and an inducer of CYP2C9, CYP2C19, and CYP2C8, did not significantly change the pharmacokinetics of prasugrel's active metabolite or its inhibition of platelet aggregation.
  • pharmacokinetics
    Therefore, known CYP3A inducers such as rifampicin, carbamazepine, and other inducers of cytochromes P450 are not expected to have significant effect on the pharmacokinetics of the active metabolite of prasugrel [see Drug Interactions ( 7.4 )] .
2 more recorded rows
  • Interaction statement pharmacokinetics
    Potential for Prasugrel to Affect Other Drugs In vitro metabolism studies demonstrate that prasugrel's main circulating metabolites are not likely to cause clinically significant inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A, or induction of CYP1A2 or CYP3A.
  • Interaction statement pharmacokinetics
    Drugs Metabolized by CYP2B6 - Prasugrel is a weak inhibitor of CYP2B6.
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole

CYP2B6

  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Sofpironium, Bupropion, Golodirsen, Tinidazole, Naldemedine
  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Sofpironium, Bupropion, Golodirsen, Tinidazole, Naldemedine

CYP2C19

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • CYP2C8
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Golodirsen, Naldemedine, Methylnaltrexone, Lapatinib, Tivozanib

CYP2C9

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • CYP3A5
    Levamlodipine, Avapritinib, Ponesimod, Selumetinib, Paliperidone, Tezacaftor, Etripamil, Trastuzumab emtansine

recorded 2026-04-08 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201772
PubChem CID
6918456
CAS number
150322-43-3
RxCUI
613391
InChIKey
DTGLZDAWLRGWQN-UHFFFAOYSA-N
Trade name
Efient, Effient, Prasugrel viatris (previously prasugrel mylan)
Development code
LY-640315, NSC-759625, LY640315
Also called
cs-747, thienopyridine, thienopyridines, PRASUGREL HYDROCHLORIDE, Prasu doc, PRASUGREL BESYLATE, PRASUGREL [EMA EPAR], PRASUGREL [MI], PRASUGREL [VANDF], Prasugrel [WHO-DD], prasugrel [INN]
Salt form
Prasugrel hcl
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.