Drugs / Gefapixant

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Lyfnua 2023-09-15 europa.eu

Trials 27 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05813223 Jan 2024 → Oct 2025 Stuart Mazzone Unknown No outcome recorded
Phase 15 trials
Phase 1 NCT03882801 Apr → Oct 2019 obstructive sleep apnea syndrome Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT03108924 Apr → Sep 2017 impaired renal function disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT02790840 May → Jun 2016 Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 1 NCT02492776 Jul → Aug 2015 Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 1 NCT02229877 Oct 2014 → May 2015 Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 214 trials
Phase 2 NCT03654326 Sep 2018 → Jun 2020 endometriosis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT03569033 Jul → Oct 2018 Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 2 NCT03482713 Mar → Jun 2018 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT02612623 Dec 2015 → May 2016 respiratory system disorder Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 2 NCT02612610 Dec 2015 → Oct 2016 upper respiratory tract disorder Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 2 NCT02476890 Oct 2015 → Oct 2016 upper respiratory tract disorder Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 2 NCT02502097 Aug 2015 → Jul 2016 idiopathic pulmonary fibrosis Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 2 NCT02477709 Jul → Aug 2015 idiopathic pulmonary fibrosis Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 2 NCT02397460 Apr 2015 → Apr 2016 respiratory system disorder Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 2 NCT02349425 Mar 2015 → Feb 2016 upper respiratory tract disorder Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Completed No outcome recorded
Phase 36 trials
Phase 3 NCT04193202 May 2020 → Oct 2021 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT04193176 May 2020 → Aug 2022 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT04525885 May 2019 → Sep 2022 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT03696108 Oct 2018 → Oct 2020 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT03449147 Mar 2018 → Aug 2020 respiratory system disorder Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT03449134 Mar 2018 → Jun 2020 respiratory system disorder Merck Sharp & Dohme LLC Completed No outcome recorded
Phase not applicable1 trial
NCT06542484 Dec 2024 → Mar 2026 overdue Nagoya City University Recruiting No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as Gefapixant ClinicalTrials.gov intervention name — accepted as the source's own label NCT02397460
26

NCT03882801

NCT02492776

NCT03449134

NCT01569438

NCT02502097

NCT04193202

NCT03482713

NCT05813223

NCT01993329

NCT02476890

NCT03654326

NCT03696108

NCT03569033

NCT02229877

NCT03449147

NCT02612610

NCT02612623

NCT02477709

NCT01432730

NCT02790840

NCT03108924

NCT04193176

NCT06542484

NCT04525885

NCT01554579

NCT02349425

Known as AF-219 “The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)” NCT01569438
Known as AF-219 CITRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL3716057
Known as Gefapixant Citrate “Drug: Gefapixant CitrateNCT06542484
Known as Lyfnua ChEMBL registry synonym — accepted as the source's own label CHEMBL3716057
Known as MK-7264 “The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)” NCT01569438
Known as MK-7264 CITRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL3716057
Known as R-1646 ChEMBL registry synonym — accepted as the source's own label CHEMBL3716057
Known as RG-1646 ChEMBL registry synonym — accepted as the source's own label CHEMBL3716057
Known as RO-4926219 ChEMBL registry synonym — accepted as the source's own label CHEMBL3716057
Action Inhibit “Gefapixant is a P2X3-receptor antagonist” PMID 35510785 May 2022
Modality Small molecule CHEMBL3716057
Route Oral orally with food for 4 weeks” NCT01569438
Target P2RX3 “a P2X3 antagonist” PMID 31023843 Jul 2019