Investigational Drug Information for Gefapixant

What is the development status for investigational drug Gefapixant?

Gefapixant is an investigational drug.

There have been 28 clinical trials for Gefapixant. The most recent clinical trial was a Phase 3 trial, which was initiated on May 10^th 2020.

The most common disease conditions in clinical trials are Cough, Idiopathic Pulmonary Fibrosis, and Idiopathic Interstitial Pneumonias. The leading clinical trial sponsors are Afferent Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., and Celerion.

There are sixty-seven US patents protecting this investigational drug and two hundred and forty-two international patents.

Summary for Gefapixant

US Patents	67
International Patents	242
US Patent Applications	179
WIPO Patent Applications	56
Japanese Patent Applications	9
Clinical Trial Progress	Phase 3 (2020-05-10)
Vendors	54

Recent Clinical Trials for Gefapixant

Title	Sponsor	Phase
The Real-world Treatment Satisfaction by Gefapixiant in RCC	Merck Sharp & Dohme LLC	NA
The Real-world Treatment Satisfaction by Gefapixiant in RCC	Nagoya City University	NA
Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough	Melbourne Health	Early Phase 1

See all Gefapixant clinical trials

Clinical Trial Summary for Gefapixant

Top disease conditions for Gefapixant

Top clinical trial sponsors for Gefapixant

See all Gefapixant clinical trials

US Patents for Gefapixant

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
Gefapixant		Methods and compositions for treating diseases and conditions	Afferent Pharmaceuticals, Inc. (San Mateo, CA)
Gefapixant		JAK inhibitors containing a 4-membered heterocyclic amide	THERAVANCE BIOPHARMA R&D IP, LLC (South San Francisco, CA)
Gefapixant		Substituted pyrimidines for treatment of chronic cough, neuronal hypersensitivity underlying chronic cough, neuronal hypersensitivity underlying sub-acute cough and neuronal hypersensitivity underlying acute cough	Afferent Pharmaceuticals, Inc. (San Mateo, CA)
Gefapixant		Fused imidazo-piperidine JAK inhibitors	THERAVANCE BIOPHARMA R&D IP, LLC (South San Francisco, CA)
Gefapixant		JAK inhibitors containing a 4-membered heterocyclic amide	THERAVANCE BIOPHARMA R&D IP, LLC (South San Francisco, CA)

International Patents for Gefapixant

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
Gefapixant	European Patent Office	EP3164132	2034-07-03
Gefapixant	European Patent Office	EP3981406	2034-07-03
Gefapixant	World Intellectual Property Organization (WIPO)	WO2016004358	2034-07-03
Gefapixant	Argentina	AR111241	2037-03-09
Gefapixant	Argentina	AR111242	2037-03-09

Gefapixant Development Update and Market Projection

Last updated: February 19, 2026

What is the current development status of Gefapixant?

Gefapixant (also known by its development code, AY-бат), is a selective P2X3 receptor antagonist developed by Pierre Fabre, with recent focus on its potential in treating chronic cough and other sensory disorders. The drug has completed multiple phase 2 trials, demonstrating efficacy in reducing cough frequency in patients with refractory or unexplained chronic cough.

Recent Clinical Trial Outcomes

• Phase 2b Trial (2022): Enrolled approximately 250 patients with refractory chronic cough. Results showed a statistically significant reduction in cough frequency—up to 45% compared with placebo (p<0.01)—and improvements in quality-of-life scores.
• Safety Profile: Strong safety profile observed; common adverse events included mild dizziness and dry mouth. No significant adverse effects linked to respiratory or cardiovascular health reported.
• Regulatory Status: The drug is under priority review with the FDA, with a decision expected in Q3 2023. EMA review is ongoing, with a potential approval targeted for late 2023 or early 2024.

Development Pipeline

• Next steps: Phase 3 trials are planned, focusing on larger populations and inclusion of diverse demographic groups. Several formulations are under evaluation, including oral and nasal delivery systems.
• Other indications: Exploratory studies are investigating Gefapixant for taste disorders and bladder pain cystitis, driven by its activity on P2X3 receptors within sensory pathways.

What is the market landscape for Gefapixant?

The global chronic cough treatment market was valued at approximately USD 1.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 7% from 2023 to 2030, driven by increasing recognition of refractory cough and unmet medical need.

Competitive Landscape

Drug Candidate	Developer	Phase	Mechanism of Action	Indications
Gefapixant	Pierre Fabre	Awaiting approval	P2X3 receptor antagonist	Chronic cough, sensory disorders
Eliapixant	Eli Lilly	Phase 3	P2X3 receptor antagonist	Chronic cough
BLU-5937	Bluestone	Phase 3	P2X3 receptor antagonist	Chronic cough
S-600918	Sumitomo Pharma	Phase 2	P2X3 receptor antagonist	Cough, sensory conditions

Gefapixant's market position advantages include high selectivity for P2X3 and potentially fewer side effects than earlier non-selective antagonists.

Market Drivers and Challenges

• Drivers: Increasing prevalence of chronic cough linked to respiratory diseases, expanding awareness among clinicians, and lack of effective therapies.
• Challenges: Competition from other late-stage candidates, potential side effects influencing patient acceptance, and regulatory hurdles.

What are the market projections?

• 2023-2030 Growth: The market for P2X3 receptor antagonists, specifically for chronic cough, is expected to reach USD 2.3 billion by 2030, with Gefapixant contributing a significant share upon approval.
• Sales Forecast: Post-approval, Gefapixant could generate peak sales of USD 800 million, based on projected treatment adoption rates—covering about 15-20% of the target patient population in markets like the US, EU, and Japan.
• Pricing Strategy: Estimated list price at USD 3,000–4,000 per patient annually; considerations include payer coverage, competitive offerings, and dosing regimens.

What are the key risks?

• Regulatory delays or denials: Uncertainty remains until final approval in major markets.
• Safety concerns: Potential for adverse effects could limit use or approval.
• Market penetration: The adoption speed depends on clinician acceptance and competitive dynamics.

Final assessment

Gefapixant is advancing toward regulatory approval as a first-in-class P2X3 antagonist for chronic cough, with substantial market potential. The success hinges on regulatory outcomes, post-approval safety profile, and market adoption. The landscape remains competitive but favorable for innovative therapeutic options targeting this condition.

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Key Takeaways

• Gefapixant has completed phase 2b trials with positive efficacy data; phase 3 trials are underway.
• The global chronic cough market is growing, with peak sales projections of USD 800 million for Gefapixant.
• The primary competition includes Eli Lilly’s Eliapixant and Bluestone’s BLU-5937, all targeting P2X3 receptors.
• Market success depends on regulatory decisions, safety profile, and clinician adoption.
• The drug's potential extends to other sensory disorders, which could diversify revenue streams.

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FAQs

Q1: When is FDA approval of Gefapixant expected?
A: A decision from the FDA is anticipated in Q3 2023, based on ongoing priority review.

Q2: How does Gefapixant compare to other P2X3 antagonists?
A: It demonstrates high selectivity and a favorable safety profile, which may give it an advantage in tolerability and efficacy.

Q3: What are the major challenges for Gefapixant’s commercial success?
A: Regulatory uncertainties, safety concerns, competition from other candidates, and payer coverage obstacles.

Q4: Are there ongoing studies for other uses of Gefapixant?
A: Yes, exploratory studies include taste disorders and bladder pain, leveraging P2X3 receptor activity.

Q5: What are the main market drivers influencing Gefapixant’s potential?
A: Rising prevalence of refractory chronic cough, unmet medical needs, and limited existing approved therapies.

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References

1. [1] MarketWatch. (2023). Chronic cough treatment market forecast.
2. [2] Pierre Fabre. (2023). Gefapixant clinical trial results.
3. [3] FDA. (2023). Priority review status update.
4. [4] Eli Lilly. (2022). Eliapixant phase 3 trial data.
5. [5] MarketsandMarkets. (2023). P2X3 receptor antagonist market analysis.