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Drug

Gefapixant

Approved · EMA
Emerging researchLate-stage developmentRising momentum
RxNorm2169701ChEMBLCHEMBL3716057UNII6K6L7E3F1L
6
Research papers
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

The Effect of Acute and Prolonged Administration of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough

Clinical trial2025-10-31Primary completion · ClinicalTrials.gov

Gefapixant as a P2X3 receptor antagonist treatment for obstructive sleep apnea: a randomized controlled trial.

Research2024-12-01Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine

A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women With Chronic Cough and Stress Urinary Incontinence

Clinical trial2024-11-05Results posted · ClinicalTrials.gov

A Phase 2a, Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women With Moderate to Severe Endometriosis-Related Pain

Clinical trial2024-11-04Results posted · ClinicalTrials.gov

A Randomized Double Blind Clinical Trial to Evaluate the Effects of MK-7264 in Participants With Obstructive Sleep Apnea

Clinical trial2024-11-04Results posted · ClinicalTrials.gov

Randomized, controlled, proof-of-concept trial of gefapixant for endometriosis-related pain.

Research2024-09-12Fertility and sterility

Efficacy and safety of gefapixant in women with chronic cough and cough-induced stress urinary incontinence: a phase 3b, randomised, multicentre, double-blind, placebo-controlled trial.

Research2024-08-30The Lancet. Respiratory medicine

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)

Clinical trial2024-01-12Results posted · ClinicalTrials.gov

Approval: Lyfnua (EMA)

Regulatory2023-09-15EMA

A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough

Clinical trial2023-05-16Results posted · ClinicalTrials.gov

The Efficacy and Safety of Gefapixant in a Phase 3b Trial of Patients with Recent-Onset Chronic Cough.

Research2023-03-06Lung

An Open-Label, Single-Dose Study to Investigate the Influence of Renal Insufficiency on the Pharmacokinetics of MK-7264

Clinical trial2022-07-27Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Gefapixant
RxNorm CUI
2169701
ChEMBL ID
CHEMBL3716057
UNII
6K6L7E3F1L
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-09-15
Latest approval
2023-09-15
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-09-15Approval
Approval: Lyfnua (EMA)

Indication: Lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

25 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
25
registered trials across all phases
LATEST COMPLETION 2022
5
Late-stage (III+)
22
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 25
Early Phase 11Phase 15Phase 214Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)

CompletedPH IIIMerck Sharp & Dohme LLCn=1612022

A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women With Chronic Cough and Stress Urinary Incontinence

CompletedPH IIIMerck Sharp & Dohme LLCn=3762022

A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough

CompletedPH IIIMerck Sharp & Dohme LLCn=4192021

A Phase 3, Randomized, Double-blind Clinical Study to Evaluate the Long-term Safety and Efficacy of MK-7264 in Japanese Adult Participants With Refractory or Unexplained Chronic Cough

CompletedPH IIIMerck Sharp & Dohme LLCn=1752020

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)

CompletedPH IIIMerck Sharp & Dohme LLCn=7322020

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)

CompletedPH IIIMerck Sharp & Dohme LLCn=1612022

A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women With Chronic Cough and Stress Urinary Incontinence

CompletedPH IIIMerck Sharp & Dohme LLCn=3762022

A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough

CompletedPH IIIMerck Sharp & Dohme LLCn=4192021

A Phase 3, Randomized, Double-blind Clinical Study to Evaluate the Long-term Safety and Efficacy of MK-7264 in Japanese Adult Participants With Refractory or Unexplained Chronic Cough

CompletedPH IIIMerck Sharp & Dohme LLCn=1752020

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)

CompletedPH IIIMerck Sharp & Dohme LLCn=7322020

A Phase 2a, Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women With Moderate to Severe Endometriosis-Related Pain

CompletedPH IIMerck Sharp & Dohme LLCn=1872020

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20202025
Most influential

Gefapixant in two randomised dose-escalation studies in chronic cough.

The European respiratory journal · 2020 · 98 cites

The Efficacy and Safety of Gefapixant in a Phase 3b Trial of Patients with Recent-Onset Chronic Cough.

Lung · 2023 · 25 cites

Randomized, controlled, proof-of-concept trial of gefapixant for endometriosis-related pain.

Fertility and sterility · 2025 · 6 cites

Effects of Renal Impairment on the Pharmacokinetics of Gefapixant, a P2X3 Receptor Antagonist.

Journal of clinical pharmacology · 2022 · 4 cites

Gefapixant as a P2X3 receptor antagonist treatment for obstructive sleep apnea: a randomized controlled trial.

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024 · 3 cites

Efficacy and safety of gefapixant in women with chronic cough and cough-induced stress urinary incontinence: a phase 3b, randomised, multicentre, double-blind, placebo-controlled trial.

The Lancet. Respiratory medicine · 2024 · 2 cites
Recent papers

Randomized, controlled, proof-of-concept trial of gefapixant for endometriosis-related pain.

Fertility and sterility · 2025 · 6 cites

Gefapixant as a P2X3 receptor antagonist treatment for obstructive sleep apnea: a randomized controlled trial.

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024 · 3 cites

Efficacy and safety of gefapixant in women with chronic cough and cough-induced stress urinary incontinence: a phase 3b, randomised, multicentre, double-blind, placebo-controlled trial.

The Lancet. Respiratory medicine · 2024 · 2 cites

The Efficacy and Safety of Gefapixant in a Phase 3b Trial of Patients with Recent-Onset Chronic Cough.

Lung · 2023 · 25 cites

Effects of Renal Impairment on the Pharmacokinetics of Gefapixant, a P2X3 Receptor Antagonist.

Journal of clinical pharmacology · 2022 · 4 cites

Gefapixant in two randomised dose-escalation studies in chronic cough.

The European respiratory journal · 2020 · 98 cites
Major research themes8
Cough3Pyrimidines2Cross-Over Studies1Endometriosis1Kidney Failure, Chronic1Pelvic Pain1Polysomnography1Purinergic P2X Receptor Antagonists1
Journals, researchers & institutions
Top journals
  • Fertility and sterility1
  • Journal of clinical pharmacology1
  • Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine1
  • Lung1
  • The European respiratory journal1
  • The Lancet. Respiratory medicine1
Leading researchers
  • Hussain A3
  • Iwamoto M2
  • La Rosa C2
  • Lu S2
  • Nguyen AM2
  • Reyfman PA2
  • Stoch SA2
  • Afzal A1
Leading institutions
free-text, unnormalised
  • Albert Einstein College of Medicine & Montefiore Medical Center1
  • Brigham and Women's Hospital and Harvard Medical School1
  • Center for Cough1
  • Centre for Human & Applied Physiological Sciences1
  • ERG Clinical1
  • Hospital Clínic1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.