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Nirmatrelvir

  • 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 Nirmatrelvir does in the body

Mild-to-moderate coronavirus disease 2019

4) ]. Ritonavir is an HIV-1 protease inhibitor but is not active against SARS-CoV-2 M pro . Ritonavir inhibits the CYP3A-mediated metabolism of nirmatrelvir, resulting in increased plasma concentrations of nirmatrelvir.

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 · 7R9A5P7H32 · read 2026-08-29

  • Its recorded molecular formula is C23H32F3N5O4, weighing 499.54.

    US prescribing information · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · read 2026-08-30

Where each sentence above came from

The recorded explanation is written in label language rather than for a beginner. 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 46 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.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

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.

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.

Community-acquired pneumonia: All-cause mortality (with subsidiary analyses of cause of death and of death at various timepoints following discharge)

The study did not show it

Who was studied
NCT04381936
How many people
70000
Study design
Phase 3
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 SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Number of days of broad-spectrum antibiotic therapy

The study did not show it

Who was studied
NCT05568654
How many people
28580
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 SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

All-cause mortality

The study did not show it

Who was studied
NCT02735707
How many people
20000
Study design
Phase 3
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 SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Rate of viral clearance for interventions relative to the no study arm (This is a superiority comparison)

The study did not show it

Who was studied
NCT05041907
How many people
3800
Study design
Phase 2
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 SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline

The study did not show it

Who was studied
NCT05047601
How many people
2954
Study design
Phase 2/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 SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

A hierarchical ordinal scale that is a composite of mortality during the acute hospital admission and the duration of organ failure support while admitted to an ICU up until the end of study day 21.

The study did not show it

Who was studied
NCT04483960
How many people
2200
Study design
Phase 3
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 SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · 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 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.

  • PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

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: “The optimal dose of PAXLOVID has not been established in pediatric patients.”

    US prescribing information · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · read 2026-08-30

  • On older people, the label states: “Clinical studies of PAXLOVID include subjects 65 years of age and older and their data contributes to the overall assessment of safety and efficacy [see Adverse Reactions (6.1) and Clinical Studies (14.1) ] .”

    US prescribing information · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available data on the use of nirmatrelvir during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”

    US prescribing information · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Nirmatrelvir and ritonavir are present in human breast milk in small amounts (less than 2%).”

    US prescribing information · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage adjustment of PAXLOVID is recommended for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.”

    US prescribing information · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · read 2026-08-30

  • On people with reduced kidney function, the label states: “increases nirmatrelvir exposure, which may increase the risk of PAXLOVID adverse reactions.”

    US prescribing information · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · 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 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

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 tablet, 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.

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

  • 7 products list this as an active ingredient in the United States drug directory. 7 of them contain it and nothing else.

    FDA National Drug Code directory · 69766-105 · read 2026-08-29

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

    FDA National Drug Code directory · 69766-105 · read 2026-08-29

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 Nirmatrelvir 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 Nirmatrelvir 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.

Where else this substance is registered

FDA substance identifier (UNII)
7R9A5P7H32
CAS registry number
2628280-40-8
PubChem compound
155903259
ChEBI
170007
WHO international nonproprietary name list entry
12161
RxNorm concept
2587892
EMA substance identifier
300000031355

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

  • 1 approved application covers products containing this substance. The earliest was NDA217188, approved 20230525 to PFIZER.

    Drugs@FDA application register · NDA217188 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA217188 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20211126.

    FDA National Drug Code directory · 69766-105 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

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.

Recorded evidence blocks (10)

On the Nirmatrelvir label: indicated for what?


"PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. ( 1 ) Limitations of Use PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of…": indications and usage on Nirmatrelvir's label. DailyMed label · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · 2026-08-30

40 registered trials of Nirmatrelvir — at which phases?


Registered studies posting no result
32 of 40

40 registered studies of Nirmatrelvir: 13 na or unstated, 11 phase2, 8 phase3, 6 phase1, 2 phase4, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

50 with a PubMed record

Show the evidence
  • na or unstated
    13
  • phase2
    11
  • phase3
    8
  • phase1
    6
  • phase4
    2
  • early phase1
    1
7 more recorded rows
  • completed
    16
  • recruiting
    8
  • unknown
    8
  • withdrawn
    3
  • active not recruiting
    2
  • terminated
    2
  • not yet recruiting
    1

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

5 of Nirmatrelvir's trials stopped: safety, accrual/recruitment, other?


safety (3), accrual/recruitment (1) and other (1): Nirmatrelvir's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The trial prematurely terminated due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety concerns."; 5 of 40 registered studies

Show the evidence

Trial

  • NCT05386472
    terminated; "The trial prematurely terminated due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety concerns."
  • NCT05487040
    terminated; "Decision to terminate study was due to slow enrolment and FDA input that available data may be enough for dosing recommendations for severe renal disease (subject to review by FDA)."
  • NCT05545319
    withdrawn; "Termination due to challenges related to the operational feasibility of the study, taking into account the current epidemiology and declining hospitalization rates for severe COVID-19."
  • NCT05997485
    withdrawn; "The study was prematurely discontinued due to the substantial delay in initiation the study. This decision was not due to major safety concerns or requests from any regulatory authorities."
  • NCT06397144
    withdrawn; "Sponsor business decision to terminate study. Decision not due to major safety concerns or requests from any regulatory authorities."

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

Human studies of Nirmatrelvir used Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose) — over how long?


Human studies of Nirmatrelvir used "Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose)". ClinicalTrials.gov · 2026-09-01

3 recorded entries; human; also "Nirmatrelvir 150 mg + Ritonavir 100 mg (test)", "Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)"

Show the evidence

human

  • NCT05491330
    Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose)
  • NCT05491330
    Nirmatrelvir 150 mg + Ritonavir 100 mg (test)
  • NCT05491330
    Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)

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

Which running trial of Nirmatrelvir could settle lifespan?


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

2 open trials; 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
  • NCT04381936
    "Randomised Evaluation of COVID-19 Therapy"; n 70000; "Community-acquired pneumonia: All-cause mortality (with subsidiary analyses of cause of death and of death at various timepoints following discharge)"; 2038-09-30

Which 5 trials of Nirmatrelvir posted no result?


Posted no result
5 of 5 completed trials
Registrations
NCT05341609, NCT05491330, NCT05624840, NCT06349655 and NCT05668091
Completion dates
oldest 2022-05-31; newest 2024-08-21
Show the evidence

Trial

  • NCT05341609
    2022-05-31
  • NCT05491330
    2022-10-27
  • NCT05624840
    2023-02-01
  • NCT06349655
    2024-03-10
  • NCT05668091
    2024-08-21

At the median, Nirmatrelvir's trials enrolled 215 people — anything larger?


Median enrolment
215
Largest enrolment
131005
Registered trials counted
40

What do 53 spontaneous reports say about Nirmatrelvir — 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.

Nirmatrelvir appears in spontaneous reports to regulators. Across the 6 most-reported reaction terms, 53 reaction mentions were counted: drug interaction 20; toxicity to various agents 13; acute kidney injury 10; immunosuppressant drug level increased 6. FAERS via Open Targets · CHEMBL4802135 · 2026-06-24

Show the evidence
  • drug interaction
    20
  • toxicity to various agents
    13
  • acute kidney injury
    10
  • immunosuppressant drug level increased
    6
  • bacterial translocation
    2
  • immunosuppressant drug level abnormal
    2

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

Which 6 reactions does Nirmatrelvir's label not list?


acute kidney injury, bacterial translocation and drug interaction and 3 more reported for Nirmatrelvir, absent from its label. FAERS via Open Targets · CHEMBL4802135 · 2026-06-24

3 label terms; 6 reported and unlisted; 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a

Show the evidence
  • acute kidney injury
    count not stated
  • bacterial translocation
    count not stated
  • drug interaction
    count not stated
  • immunosuppressant drug level abnormal
    count not stated
  • immunosuppressant drug level increased
    count not stated
  • toxicity to various agents
    count not stated

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

Nirmatrelvir and BCRP, CYP3A4 and OATP1B1: shared by which compounds?


BCRP, CYP3A4 and OATP1B1 appear in Nirmatrelvir's recorded interaction sentences, 8 in all. DailyMed label · 8a99d6d6-fd9e-45bb-b1bf-48c7f761232a · 2026-08-30

CYP1A2, CYP2B6, CYP2C19, CYP2C9, CYP2D6, CYP3A; 31 shared nodes; clinical_pharmacology, pharmacokinetics

Show the evidence

Interaction statement

  • clinical_pharmacology
    Nirmatrelvir is a substrate for P-gp, but not BCRP, MATE1, MATE2K, NTCP, OAT1, OAT2, OAT3, OCT1, OCT2, PEPT1, OATP1B1, OATP1B3, OATP2B1, or OATP4C1. 12.4 Microbiology Mechanism of Action Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (M pro ), also referred to as 3C-like protease (3CL pro ) or nonstructural protein 5 (nsp5) protease.
  • pharmacokinetics
    Nirmatrelvir is a substrate for P-gp, but not BCRP, MATE1, MATE2K, NTCP, OAT1, OAT2, OAT3, OCT1, OCT2, PEPT1, OATP1B1, OATP1B3, OATP2B1, or OATP4C1.
  • pharmacokinetics
    Ritonavir is an inducer of CYP1A2, CYP2C9, CYP2C19, CYP2B6, and CYP3A.
  • pharmacokinetics
    Nirmatrelvir is an inducer of CYP2B6, 2C8, 2C9, and 3A4, but there is minimal risk for pharmacokinetic interactions arising from induction of these CYP enzymes at the proposed therapeutic dose. • Ritonavir is a substrate of CYP2D6 and CYP3A.
  • pharmacokinetics
    CYP3A4=cytochrome P450 3A4;
  • pharmacokinetics
    Midazolam is an index substrate for CYP3A4.
2 more recorded rows
  • Interaction statement pharmacokinetics
    OATP1B1=organic anion transporter polypeptide 1B1;
  • Interaction statement pharmacokinetics
    Transporter Systems: Nirmatrelvir is an inhibitor of P-gp and OATP1B1.
  • 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
  • CYP2C19
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • CYP2C9
    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

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

BCRP

  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Omadacycline
  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Omadacycline

MATE1

  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Sofpironium, Golodirsen, Eravacycline, Prucalopride, Chenodeoxycholic acid
  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Sofpironium, Golodirsen, Eravacycline, Prucalopride, Chenodeoxycholic acid

MATE2-K

  • TAFAMIDIS MEGLUMINE, Arimoclomol, Sofpironium, Golodirsen, Eravacycline, Prucalopride, Chenodeoxycholic acid, Methylnaltrexone
  • TAFAMIDIS MEGLUMINE, Arimoclomol, Sofpironium, Golodirsen, Eravacycline, Prucalopride, Chenodeoxycholic acid, Methylnaltrexone

OAT1

  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Prucalopride
  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Prucalopride

OAT3

  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Pemetrexed, Eravacycline
  • TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Pemetrexed, Eravacycline

OATP1B1

  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline
  • FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL4802135
PubChem CID
155903259
CAS number
2628280-40-8
RxCUI
2587892
InChIKey
LIENCHBZNNMNKG-OJFNHCPVSA-N
Trade name
Nirmatrelvir component of paxlovid, Paxlovid (Copackaged), PAXLOVID COMPONENT NIRMATRELVIR
Also called
Pf-07321332, nirmatrelvir-ritonavir, pf-07321332/ritonavir, NIRMATRELVIR [JAN], NIRMATRELVIR [USAN], Nirmatrelvir [MI], Nirmatrelvir [WHO-DD], nirmatrelvir [INN]
Development code
PF07321332
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · 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.