23 completed, 2 terminated, 1 unknown. 14 Phase 2, 6 Phase 3, 5 Phase 1, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 12, Terminated 2 |
| Phase 3 | 6 | Completed 6 |
| Phase 1 | 5 | Completed 5 |
| Early Phase 1 | 1 | Unknown 1 |
Follow Gefapixant: new trials by email Literature Review of Gefapixant trials Research Report on Gefapixant
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough Gefapixant - Chronic Cough | Early Phase 1 | Unknown | Stuart Mazzone | 31 | 2024-01-01 | 2024-05-09 |
| Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043) Gefapixant, Placebo - Chronic Cough | Phase 3 | Completed | Merck Sharp & Dohme LLC | 419 | 2020-05-21 | 2023-05-16 |
| Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042) Gefapixant, Placebo - Chronic Cough | Phase 3 | Completed | Merck Sharp & Dohme LLC | 376 | 2020-05-10 | 2024-11-05 |
| A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension Gefapixant 45 mg twice daily (BID), Gefapixant 15 mg BID, Placebo - Chronic Cough | Phase 3 | Completed | Merck Sharp & Dohme LLC | 161 | 2019-05-17 | 2024-01-12 |
| Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039) Gefapixant, Placebo - Obstructive Sleep Apnea (OSA) | Phase 1 | Completed | Merck Sharp & Dohme LLC | 24 | 2019-04-10 | 2024-11-04 |
| A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038) Gefapixant, Placebo - Chronic Cough | Phase 3 | Completed | Merck Sharp & Dohme LLC | 175 | 2018-10-31 | 2021-11-01 |
| A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034) Gefapixant, Placebo, Naproxen - Endometriosis-related Pain | Phase 2 | Completed | Merck Sharp & Dohme LLC | 187 | 2018-09-11 | 2024-11-04 |
| Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013) Gefapixant, Placebo - Acute Cough | Phase 2 | Terminated | Merck Sharp & Dohme LLC | 46 | 2018-07-04 | 2019-12-10 |
| Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033) Gefapixant 45 mg, Placebo - Chronic Cough | Phase 2 | Completed | Merck Sharp & Dohme LLC | 23 | 2018-03-16 | 2019-10-17 |
| A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030) Placebo, Gefapixant 15 mg BID, Gefapixant 45 mg BID - Chronic Cough | Phase 3 | Completed | Merck Sharp & Dohme LLC | 1317 | 2018-03-15 | 2021-09-02 |
| A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027) Placebo, Gefapixant - Chronic Cough | Phase 3 | Completed | Merck Sharp & Dohme LLC | 732 | 2018-03-14 | 2021-06-16 |
| The Pharmacokinetics of Gefapixant (MK-7264) in Participants With Renal Insufficiency (MK-7264-026) Gefapixant - Renal Insufficiency | Phase 1 | Completed | Merck Sharp & Dohme LLC | 24 | 2017-04-14 | 2022-07-27 |
| A Multiple-Dose Pharmacokinetics Study of Three Gefapixant (AF-219/MK-7264) Formulations Omeprazole, Gefapixant - Healthy | Phase 1 | Completed | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 32 | 2016-05-16 | 2017-04-18 |
| An 8-Week Refractory Chronic Cough Study (MK-7264-021) Gefapixant, Placebo (for gefapixant) - Refractory Chronic Cough | Phase 2 | Completed | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 24 | 2015-12-17 | 2019-11-25 |
| A 12-Week Study in Participants With Refractory Chronic Cough (MK-7264-012) Gefapixant, Placebo (for gefapixant) - Refractory Chronic Cough | Phase 2 | Completed | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 253 | 2015-12-15 | 2020-06-30 |
| Effect of Gefapixant (MK-7264/AF-219) on Cough Reflex Sensitivity in Healthy and Chronic Cough Participants (MK-7264-014) Gefapixant 100 mg, Placebo - Refractory Chronic Cough | Phase 2 | Completed | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 36 | 2015-10-28 | 2019-06-18 |
| A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016) Gefapixant, Placebo - Idiopathic Pulmonary Fibrosis, Cough | Phase 2 | Completed | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 51 | 2015-08-26 | 2021-05-26 |
| A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Gefapixant - Idiopathic Pulmonary Fibrosis | Phase 2 | Completed | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 6 | 2015-07-20 | 2019-06-25 |
| A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations Omeprazole, Gefapixant - Healthy | Phase 1 | Completed | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 14 | 2015-07-07 | 2022-07-22 |
| Effect of Gefapixant (AF-219/MK-7264) on Cough Reflex Sensitivity (MK-7264-015) Gefapixant, Placebo - Refractory Chronic Cough | Phase 2 | Completed | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 50 | 2015-04-29 | 2021-02-12 |
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Chronic Cough (14) · Cough (3) · Idiopathic Pulmonary Fibrosis (2) · Respiration Disorders (2) · Respiratory Tract Diseases (2) · Signs and Symptoms (2) · Signs and Symptoms, Respiratory (2) · Asthma (1) · Cystitis, Interstitial (1) · Osteoarthritis, Knee (1) · Renal Insufficiency (1) · Sleep Apnea, Obstructive (1) · Urinary Incontinence, Stress (1)
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (14) · Merck Sharp & Dohme LLC (11) · Stuart Mazzone (1)
United States (13) · United Kingdom (6) · Ukraine (5) · Peru (4) · Poland (4) · Spain (4) · Australia (3) · Canada (3) · Colombia (3) · Germany (3) · Guatemala (3) · Israel (3) · Japan (3) · Russia (3) · South Korea (3)
Danielle Armas, MD (1) · Dennis Swearingen, MD (1) · Selwyn Spangenthal (1) · Stuart B Mazzone, PhD (1) · Terry O'Reilly, M.D. (1)
PMID 35248186, PMID 35510785, PMID 35569802, PMID 25467586, PMID 31023843, PMID 31949115, PMID 32109425, PMID 32734597, PMID 33825965, PMID 34152585, PMID 34697975, PMID 35614875, PMID 35656754, PMID 35752582, PMID 35969360, PMID 36348054, PMID 36879087, PMID 39069967, PMID 39222649, PMID 39260540
2015 (4), 2017 (3), 2018 (2), 2019 (2)