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Atazanavir

  • 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 Atazanavir does in the body

HIV-1 infection

4) ] .

What happened in people

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

A fixed RNAWiki sentence

Where this came from

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

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 4MT4VIE29P · read 2026-08-29

  • Its recorded molecular formula is C38H52N6O7•H2SO4, weighing 802.9.

    US prescribing information · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · 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.

No statement of the main limit is recorded.

The four opening statements run to 16 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

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.

Financial impact on the total cost of patient care resulting from implementation of a Pharmacogenetics testing program within a safety-net and Academic healthcare system

The study did not show it

Who was studied
NCT02297126
How many people
4465
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms

The study did not show it

Who was studied
NCT00074581
How many people
3526
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Time From Randomization to Virologic Failure

The study did not show it

Who was studied
NCT00118898
How many people
1864
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Cumulative Probability of First Virologic Failure by Week 96

The study did not show it

Who was studied
NCT00811954
How many people
1814
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death

The study did not show it

Who was studied
NCT00955968
How many people
1653
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Time to Treatment Failure (PI Comparison)

The study did not show it

Who was studied
NCT00084136
How many people
1571
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.2 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

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

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • plasma hiv 1 rna 50 copies/ at week 48
  • maximum plasma concentration

Meaningful

Things that change how a life goes, not only a number.

No registered study measured anything of this kind.

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (38)
  • time to treatment failure
  • time from randomization to virologic failure
  • time from treatment dispensation to a grade 3/4 safety event
  • time from treatment dispensation to treatment modification
  • treatment response at week 48
  • safety assessments
  • pharmacokinetic assessments
  • virologic response
  • neuropsychological performance change
  • cumulative probability of first virologic failure by week 96
  • reaching virologic failure at week 48
  • tenofovir systemic exposure during the follicular phase
  • tenofovir systemic exposure during the luteal phase
  • emtricitabine systemic exposure during the follicular phase
  • emtricitabine systemic exposure during the luteal phase
  • ritonavir systemic exposure during the follicular phase
  • ritonavir systemic exposure during the luteal phase
  • hiv 1 rna 50 copies/ at week 24
  • pharmacokinetic results of etravirine
  • laboratory test results worst toxicity of grade 3 4

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

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

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 12.1 hours hours

    Read from the label, which states: “The mean half-life of atazanavir in hepatically impaired participants was 12.1 hours compared to 6.4 hours in healthy participants.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

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.

  • Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ( 8.4 )].

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: “Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1, at least 6 years of age and older and weighing at least 15 kg.”

    US prescribing information · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · read 2026-08-30

  • On older people, the label states: “Clinical studies of atazanavir did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.”

    US prescribing information · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Atazanavir has been evaluated in a limited number of women during pregnancy.”

    US prescribing information · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Atazanavir has been detected in human milk.”

    US prescribing information · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · read 2026-08-30

Where the result stopped carrying

  • 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 for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

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 (10)
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

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

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

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

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Sold as capsule, tablet, powder, capsule, gelatin coated, given by the oral route.

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 and what that means for what is in the pack.

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 takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Reports sent to a regulator

  • 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.

Atazanavir appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2366 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • drug interaction — 437 reaction mentions
  • abortion spontaneous — 291 reaction mentions
  • nephrolithiasis — 272 reaction mentions
  • hyperbilirubinaemia — 242 reaction mentions
  • depression — 239 reaction mentions
  • premature baby — 208 reaction mentions
  • jaundice — 201 reaction mentions
  • blood bilirubin increased — 199 reaction mentions
  • virologic failure — 145 reaction mentions
  • lipodystrophy acquired — 132 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

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

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 40 products list this as an active ingredient in the United States drug directory. 38 of them contain it and nothing else.

    FDA National Drug Code directory · 14593-806 · read 2026-08-29

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

    FDA National Drug Code directory · 14593-806 · read 2026-08-29

  • The regulator's established pharmacologic class for it is cytochrome p450 2c8 inhibitors [moa], cytochrome p450 3a inhibitors [moa] and cytochrome p450 3a4 inhibitors [moa].

    FDA National Drug Code directory · 14593-806 · read 2026-08-29

  • 6 published labels name it as an active ingredient. 5 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · read 2026-08-29

  • Atazanavir Sulfate is oral at 3 DOSAGE FORMS AND STRENGTHS 100 mg Capsules are blue/white size ‘2’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘100 mg’ on blue cap with white edible ink and ‘T23’ on w…, recorded as fda label in effect 2025-08-06 in the United States.

    US prescribing information · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · read 2026-08-30

  • Recorded price in US: 1.10873–2.30863 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 8 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.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Atazanavir 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

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 Atazanavir 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.

How many documents were read

  • 5 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

  • 5 of them state the same tMax, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
4MT4VIE29P
RxNorm concept
402245

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • 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

  • 17 approved applications cover products containing this substance. The earliest was NDA021567, approved 20030620 to BRISTOL MYERS SQUIBB.

    Drugs@FDA application register · NDA021567 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA021567 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20030620.

    FDA National Drug Code directory · 14593-806 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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Recorded evidence blocks (13)

What did Atazanavir's largest trial (3526 people) and its longest (13 years) measure?


3526 people in Atazanavir's largest registered study, 13 years in its longest registered window, measuring Clearance estimates for each drug, adjusted for age and frailty. ClinicalTrials.gov · 2026-09-01

36 phase3, 32 phase1, 28 phase4, 21 phase2, 7 na, 6 na or unstated; NCT01003990; 2016-02. Last human test completed 2023, NCT04184869.

Interpretation These counts include studies where Atazanavir was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase3
    36
  • phase1
    32
  • phase4
    28
  • phase2
    21
  • na
    7
  • na or unstated
    6
1 more recorded row
  • Last recorded human test NCT04184869
    2023-03-31

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

Atazanavir was tested only in human — what did it show?


human: healthspan (124): the rungs where Atazanavir has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Clearance estimates for each drug, adjusted for age and frailty — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human healthspan
Show the evidence
  • human NCT01180075
    healthspan; Clearance estimates for each drug, adjusted for age and frailty; 124

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

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


safety (2), futility/efficacy (1), accrual/recruitment (5), funding/business (1) and other (2): Atazanavir's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"insufficient enrollment"; 11 of 124 registered studies

Show the evidence

Trial

  • NCT00312754
    terminated; "insufficient enrollment"
  • NCT00420355
    terminated; "Unexpected adverse event"
  • NCT00768989
    terminated; "Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population."
  • NCT01194856
    terminated; "Closed due to low enrollment"
  • NCT01255371
    withdrawn; "drug procurement issues"
  • NCT01620944
    terminated; "Business objectives have changed"
5 further recorded trials
  • NCT01902186
    terminated; "Low enrollment"
  • NCT02116660
    terminated; "This study was terminated early due to poor recruitment."
  • NCT02386098
    terminated; "GI Intolerability"
  • NCT02566707
    terminated; "due to introduction of another integrase inhibitor, recruitement was not feasible anymore."
  • NCT02697851
    terminated; "Insufficient enrolment and "business reasons""

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

Human studies of Atazanavir used Reyataz 300 mg capsules — over how long?


Human studies of Atazanavir used "Reyataz 300 mg capsules". ClinicalTrials.gov · 2026-09-01

9 recorded entries; human; also "Atazanavir 300 mg", "Atazanavir 400 mg", "Atazanavir (ATV) 300 mg"

Show the evidence

human

  • NCT00420355
    Reyataz 300 mg capsules
  • NCT00552240
    Atazanavir 300 mg
  • NCT00883935
    Atazanavir 400 mg
  • NCT00896051
    Atazanavir (ATV) 300 mg
  • NCT00896051
    Atazanavir (ATV) 400 mg
  • NCT01194856
    Reyataz®: 100 mg, 150 mg, 200 mg, 300 mg
3 more recorded rows
  • human NCT01818856
    Ritonavir withdrawal, atazanavir 200 mg/12h
  • human NCT02034838
    atazanavir 300mg boosted with ritonavir 50 mg
  • human NCT03708861
    maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)

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

Atazanavir's half-life is 12.1 hours — which schedules were studied?


12.1 hours, the half-life Atazanavir's label states. openfda-label · 7fbea274-d6b5-4faa-bbf0-05fefab42114 · 2026-08-30

Show the evidence
  • half life
    12.1 hours hours; The mean half-life of atazanavir in hepatically impaired participants was 12.1 hours compared to 6.4 hours in healthy participants.
  • tmax
    Table 17: Steady-State Pharmacokinetics of Atazanavir in Healthy Participants or Participants with HIV-1 in the Fed State 400 mg once daily 300 mg with ritonavir 100 mg once daily Parameter Healthy Participants (n=14) Participants with HIV-1 (n=13) Healthy Participants (n=28) Participants with HIV-1 (n=10) C max (ng/mL) Geometric mean (CV%) 5199 (26) 2298 (71) 6129 (31) 4422 (58) Mean (SD) 5358…
  • bioavailability
    Food Effect Administration of atazanavir with food enhances bioavailability and reduces pharmacokinetic variability.
  • metabolism
    Metabolism Atazanavir is extensively metabolized in humans.

recorded 2026-08-30 · last checked 2026-09-04

Could one person measure Atazanavir's effect on time to treatment failure?


Time to treatment failure: measured in Atazanavir's trials.

Interpretation time to treatment failure is the recorded endpoint.

Show the evidence

biomarkers

  • time to treatment failure; 2026-09-01
  • time from randomization to virologic failure; 2026-09-01
  • time from treatment dispensation to a grade 3/4 safety event; 2026-09-01
  • time from treatment dispensation to treatment modification; 2026-09-01
  • treatment response at week 48; 2026-09-01
  • safety assessments; 2026-09-01
14 more recorded rows
  • biomarkers
    pharmacokinetic assessments; 2026-09-01
  • biomarkers
    virologic response; 2026-09-01
  • biomarkers
    neuropsychological performance change; 2026-09-01
  • biomarkers
    cumulative probability of first virologic failure by week 96; 2026-09-01
  • biomarkers
    reaching virologic failure at week 48; 2026-09-01
  • biomarkers
    tenofovir systemic exposure during the follicular phase; 2026-09-01
  • biomarkers
    tenofovir systemic exposure during the luteal phase; 2026-09-01
  • biomarkers
    emtricitabine systemic exposure during the follicular phase; 2026-09-01
  • biomarkers
    emtricitabine systemic exposure during the luteal phase; 2026-09-01
  • biomarkers
    ritonavir systemic exposure during the follicular phase; 2026-09-01
  • biomarkers
    ritonavir systemic exposure during the luteal phase; 2026-09-01
  • biomarkers
    hiv 1 rna 50 copies/ at week 24; 2026-09-01
  • biomarkers
    pharmacokinetic results of etravirine; 2026-09-01
  • biomarkers
    laboratory test results worst toxicity of grade 3 4; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 12.1 hours; 2026-08-30
  • human trials at or under30
    37
  • smallest human trial
    0; NCT01255371; PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of absorption constant, brachial artery diameter and centers for disease control class c aids events did Atazanavir's trials measure?


absorption constant, brachial artery diameter and centers for disease control class c aids events lead 40 outcome terms across Atazanavir's trials. ClinicalTrials.gov · 2026-09-01

time from treatment dispensation to treatment modification, treatment response at week 48, safety assessments, pharmacokinetic assessments, virologic response and neuropsychological performance change follow.

Show the evidence
  • time to treatment failure
    1
  • time from randomization to virologic failure
    1
  • time from treatment dispensation to a grade 3/4 safety event
    1
  • time from treatment dispensation to treatment modification
    1
  • treatment response at week 48
    1
  • safety assessments
    1
14 more recorded rows
  • pharmacokinetic assessments
    1
  • virologic response
    1
  • neuropsychological performance change
    1
  • cumulative probability of first virologic failure by week 96
    1
  • reaching virologic failure at week 48
    1
  • tenofovir systemic exposure during the follicular phase
    1
  • tenofovir systemic exposure during the luteal phase
    1
  • emtricitabine systemic exposure during the follicular phase
    1
  • emtricitabine systemic exposure during the luteal phase
    1
  • ritonavir systemic exposure during the follicular phase
    1
  • ritonavir systemic exposure during the luteal phase
    1
  • hiv 1 rna 50 copies/ at week 24
    1
  • pharmacokinetic results of etravirine
    1
  • laboratory test results worst toxicity of grade 3 4
    1

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

What will the one ongoing trial of Atazanavir report, and when?


1 registered trial of Atazanavir is open; earliest completion 2027-03. ClinicalTrials.gov · 2026-09-01

Interpretation Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV

Show the evidence
  • Trial NCT02016924
    "Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV"; n 133; "Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV"; 2027-03

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

Which 52 trials of Atazanavir posted no result?


Posted no result
52 of 52 completed trials
Registrations
NCT00002240, NCT00004584, NCT00013897, NCT00028301, NCT00067782 and NCT00013520, and 46 more
Completion dates
oldest 2001-12; newest 2023-03-31
Show the evidence

Trial

  • NCT00002240
    2001-12
  • NCT00004584
    2002-01
  • NCT00013897
    2003-04
  • NCT00028301
    2003-09
  • NCT00067782
    2005-03
  • NCT00013520
    2005-06
14 further recorded trials
  • NCT00135395
    2006-02
  • NCT00082394
    2006-03-01
  • NCT00084019
    2006-05
  • NCT00120393
    2006-05
  • NCT00447070
    2006-05
  • NCT00162149
    2006-07
  • NCT00357240
    2006-08
  • NCT00357188
    2006-09
  • NCT00357721
    2006-09
  • NCT00007202
    2006-10
  • NCT00720590
    2006-10
  • NCT00357604
    2006-11
  • NCT00362726
    2006-11
  • NCT00224445
    2007-01

At the median, Atazanavir's trials enrolled 55 people — anything larger?


Median enrolment
55
Largest enrolment
3526
Registered trials counted
116

What do 2366 spontaneous reports say about Atazanavir — 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.

Atazanavir appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2366 reaction mentions were counted: drug interaction 437; abortion spontaneous 291; nephrolithiasis 272; hyperbilirubinaemia 242. open-targets-adr · CHEMBL1163 · 2026-06-24

Show the evidence
  • drug interaction
    437
  • abortion spontaneous
    291
  • nephrolithiasis
    272
  • hyperbilirubinaemia
    242
  • depression
    239
  • premature baby
    208
4 more recorded rows
  • jaundice
    201
  • blood bilirubin increased
    199
  • virologic failure
    145
  • lipodystrophy acquired
    132

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

Atazanavir and CYP2C8, CYP2D6 and CYP1A2: shared by which compounds?


CYP2C8, CYP2D6 and CYP1A2 appear in Atazanavir's recorded interaction sentences, 10 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP1A2 pharmacokinetics
    Clinically significant interactions are not expected between atazanavir and substrates of CYP2C19, CYP2C9, CYP2D6, CYP2B6, CYP2A6, CYP1A2, or CYP2E1.
  • CYP2A6 pharmacokinetics
    Clinically significant interactions are not expected between atazanavir and substrates of CYP2C19, CYP2C9, CYP2D6, CYP2B6, CYP2A6, CYP1A2, or CYP2E1.
  • CYP2B6 pharmacokinetics
    Clinically significant interactions are not expected between atazanavir and substrates of CYP2C19, CYP2C9, CYP2D6, CYP2B6, CYP2A6, CYP1A2, or CYP2E1.
  • CYP2C19 pharmacokinetics
    Clinically significant interactions are not expected between atazanavir and substrates of CYP2C19, CYP2C9, CYP2D6, CYP2B6, CYP2A6, CYP1A2, or CYP2E1.

CYP2C8

  • pharmacokinetics
    Atazanavir is also a direct inhibitor for UGT1A1 (K i =1.9 µM) and CYP2C8 (K i =2.1 µM).
  • pharmacokinetics
    Clinically significant interactions are not expected between atazanavir when administered with ritonavir and substrates of CYP2C8.
  • CYP2C9 pharmacokinetics
    Clinically significant interactions are not expected between atazanavir and substrates of CYP2C19, CYP2C9, CYP2D6, CYP2B6, CYP2A6, CYP1A2, or CYP2E1.

CYP2D6

  • pharmacokinetics
    Clinically significant interactions are not expected between atazanavir and substrates of CYP2C19, CYP2C9, CYP2D6, CYP2B6, CYP2A6, CYP1A2, or CYP2E1.
  • pharmacokinetics
    Atazanavir does not interact with substrates of CYP2D6 (e.g., nortriptyline, desipramine, metoprolol).
  • CYP2E1 pharmacokinetics
    Clinically significant interactions are not expected between atazanavir and substrates of CYP2C19, CYP2C9, CYP2D6, CYP2B6, CYP2A6, CYP1A2, or CYP2E1.

recorded 2026-08-30 · last checked 2026-09-04

What is recorded about Atazanavir and autophagy?


"In monocyte-derived macrophages, URMC-099 induction of autophagy led to retention of nanoparticles containing the antiretroviral protease inhibitor atazanavir." — where Atazanavir and autophagy appear together. Europe PMC · pathway abstract search · 2017-01-30

autophagy; PMID 28134625

Show the evidence
  • autophagy PMID 28134625
    "In monocyte-derived macrophages, URMC-099 induction of autophagy led to retention of nanoparticles containing the antiretroviral protease inhibitor atazanavir."

recorded 2017-01-30 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1163
PubChem CID
71313511
CAS number
1292296-11-7
RxCUI
402245
InChIKey
AXRYRYVKAWYZBR-GASGPIRDSA-N
Development code
BMS-232632, CGP-73547, BMS-232632-05, NSC-742546
Trade name
Reyataz, Atazanavir krka, Atazanavir mylan, Atazanavir viatris (previously atazanavir mylan), Evotaz
Also called
atazanavir / ritonavir, atazanavir/cobicistat, atv, atv/co, atv/r, atvr, atz, atz/r, boosted atazanavir, ATAZANAVIR SULFATE, Atazanaviri sulfas, Atazanavir so4
Salt form
Atazanavir sulfate component of evotaz, Atazanavir sulphate
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · 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: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 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

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