Gefapixant

Generic Name: Gefapixant

Brand Names: Lyfnua

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₁₉N_₅O_₄S

CAS Number: 1015787-98-0

Unique Ingredient Identifier: 6K6L7E3F1L

Background: It has been estimated that 5-10% of adults globally suffer from chronic cough, which is defined as a cough lasting longer than eight weeks. A subset of these patients remain symptomatic despite thorough investigation and treatment, termed refractory chronic cough (RCC) if they have a cough that does not respond to conventional treatment or unexplained chronic cough (UCC) when no diagnosable cause for the cough can be determined. Existing treatments for chronic cough have been associated with considerable side effects, in particular opioids such as codeine or dextromethorphan.

Gefapixant is a novel antagonist of the P2X3 receptor that works to reduce the cough reflex in patients with chronic cough. It received approval in both Japan and Switzerland in 2022 for the treatment of adult patients with RCC and UCC, and received subsequent approval in the EU in September 2023 for the same indications. It is the first therapy to be approved for the treatment of RCC or UCC in the EU.

Indication: 用于成人治疗难治性慢性咳嗽（RCC）或不明原因慢性咳嗽（UCC）。

Associated Conditions: Refractory Chronic Cough, Unexplained Chronic Cough

Clinical Trials

The Real-world Treatment Satisfaction by Gefapixiant in RCC

Not Applicable

Recruiting

Conditions: Chronic Cough

Interventions: Drug: Gefapixant Citrate

First Posted Date: 2024-08-07

Last Posted Date: 2025-01-29

Lead Sponsor: Nagoya City University

Target Recruit Count: 63

Registration Number: NCT06542484

Locations: 🇯🇵
Nagoya City University Hospital, Nagoya, Aichi, Japan
🇯🇵
Nagoya City University, Nagoya, Aichi, Japan

Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough

Early Phase 1

Recruiting

Conditions: Chronic Cough

Interventions: Drug: Gefapixant

First Posted Date: 2023-04-14

Last Posted Date: 2024-05-09

Lead Sponsor: Stuart Mazzone

Target Recruit Count: 31

Registration Number: NCT05813223

Locations: 🇦🇺
The University of Melbourne, Parkville, Victoria, Australia

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension

Phase 3

Completed

Conditions: Chronic Cough

Interventions: Drug: Gefapixant 45 mg twice daily (BID)
Drug: Gefapixant 15 mg BID
Drug: Placebo
Drug: Gefapixant 45 mg BID

First Posted Date: 2020-08-25

Last Posted Date: 2024-01-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 161

Registration Number: NCT04525885

Locations: 🇨🇳
Inner Mongolia Autonomous Region Hospital ( Site 5018), Hohhot, Inner Mongolia, China
🇨🇳
The First Affiliated Hospital of Nanchang University ( Site 5012), Nanchang, Jiangxi, China
🇨🇳
ShengJing Hospital of China Medical University ( Site 5024), Shenyang, Liaoning, China

and more 5 locations

Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)

Phase 3

Completed

Conditions: Chronic Cough

Interventions: Drug: Placebo
Drug: Gefapixant

First Posted Date: 2019-12-10

Last Posted Date: 2024-11-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 376

Registration Number: NCT04193176

Locations: 🇺🇸
Florida Pulmonary Research Institute, LLC ( Site 0008), Winter Park, Florida, United States
🇩🇪
Praxis Dr. Wehgartner-Winkler ( Site 0906), Augsburg, Bayern, Germany
🇷🇺
Medi Kom ( Site 1456), Saint Petersburg, Sankt-Peterburg, Russian Federation

and more 87 locations

Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

Phase 3

Completed

Conditions: Chronic Cough

Interventions: Drug: Gefapixant
Drug: Placebo

First Posted Date: 2019-12-10

Last Posted Date: 2023-05-16

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 419

Registration Number: NCT04193202

Locations: 🇬🇹
Clinica Medica Especializada en Neumologia ( Site 0502), Guatemala, Guatemala
🇰🇷
Konkuk University Medical Center ( Site 1504), Seoul, Korea, Republic of
🇰🇷
Severance Hospital Yonsei University Health System ( Site 1503), Seoul, Korea, Republic of

and more 88 locations

Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)

Phase 1

Completed

Conditions: Obstructive Sleep Apnea (OSA)

Interventions: Drug: Gefapixant
Drug: Placebo

First Posted Date: 2019-03-20

Last Posted Date: 2024-11-04

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 24

Registration Number: NCT03882801

Locations: 🇺🇸
MD Clinical ( Site 0004), Hallandale Beach, Florida, United States
🇺🇸
Clinilabs, Inc. ( Site 0005), New York, New York, United States
🇧🇪
Universitair Ziekenhuis Gent ( Site 0012), Gent, Belgium

and more 2 locations

A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

Phase 3

Completed

Conditions: Chronic Cough

Interventions: Drug: Gefapixant
Drug: Placebo

First Posted Date: 2018-10-04

Last Posted Date: 2021-11-01

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 175

Registration Number: NCT03696108

Locations: 🇯🇵
Fukuoka University Chikushi Hospital ( Site 3886), Chikushino, Fukuoka, Japan
🇯🇵
National Hospital Organization Nagoya Medical Center ( Site 3898), Nagoya, Aichi, Japan
🇯🇵
Nagoya City University Hospital ( Site 3899), Nagoya, Aichi, Japan

and more 58 locations

A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)

Phase 2

Completed

Conditions: Endometriosis-related Pain

Interventions: Drug: Placebo
Drug: Gefapixant
Drug: Naproxen

First Posted Date: 2018-08-31

Last Posted Date: 2024-11-04

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 187

Registration Number: NCT03654326

Locations: 🇺🇸
Synexus US Phoenix Southeast ( Site 0729), Chandler, Arizona, United States
🇺🇸
Lynn Institute of the Ozarks ( Site 0720), Little Rock, Arkansas, United States
🇺🇸
Thameside OBGYN Center ( Site 0747), Groton, Connecticut, United States

and more 75 locations

Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

Phase 2

Terminated

Conditions: Acute Cough

Interventions: Drug: Placebo
Drug: Gefapixant

First Posted Date: 2018-06-26

Last Posted Date: 2019-12-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 46

Registration Number: NCT03569033

Locations: 🇬🇧
Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003), London, United Kingdom

Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)

Phase 2

Completed

Conditions: Chronic Cough

Interventions: Drug: Placebo
Drug: Gefapixant 45 mg

First Posted Date: 2018-03-29

Last Posted Date: 2019-10-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 23

Registration Number: NCT03482713

Locations: 🇯🇵
Yokohama City Minato Red Cross Hospital ( Site 3306), Yokohama, Kanagawa, Japan
🇯🇵
Tsumura Cardiovascular-internal-medicine Clinic ( Site 3314), Kakogawa, Hyogo, Japan
🇯🇵
Saiseikai Kanazawa Hospital ( Site 3337), Kanazawa, Ishikawa, Japan

and more 13 locations

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