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Gefapixant FDA Approval Status

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: No
Generic name: gefapixant
Company: Merck
Treatment for: Cough

Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

Development timeline for gefapixant

Dec 20, 2023Merck Provides U.S. Regulatory Update on Gefapixant
Nov 17, 2023Merck Provides Update on FDA Advisory Committee Meeting Evaluating Gefapixant
Jan 24, 2022Merck Provides U.S. and Japan Regulatory Update for Gefapixant
Mar  1, 2021U.S. FDA Accepts Merck’s Gefapixant New Drug Application for Review
Sep  8, 2020Merck’s Gefapixant (45 mg Twice Daily) Significantly Decreased Cough Frequency Compared to Placebo at Week 12 and 24 in Patients with Refractory or Unexplained Chronic Cough
Mar 17, 2020Merck Announces Top-Line Results from Phase 3 Trials Evaluating Gefapixant, an Investigational Treatment for Refractory or Unexplained Chronic Cough

Further information

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