21 completed, 3 active not recruiting, 2 terminated, 1 available. 14 Phase 1, 8 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 14 | Completed 14 |
| Phase 2 | 8 | Completed 6, Terminated 2 |
| Phase 3 | 3 | Active not recruiting 1, Completed 1, Recruiting 1 |
Follow danicopan: new trials by email Literature Review of danicopan trials Research Report on danicopan
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 |
|---|---|---|---|---|---|---|
| Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis of IPIG-Registry Data Danicopan, Soliris/Ultomiris - Paroxysmal Nocturnal Hemoglobinuria, PNH | Active not recruiting | Alexion Pharmaceuticals, Inc. | 50 | 2026-01-14 | 2026-02-17 | |
| Long-term Safety of Danicopan: IPIG Registry-based Cohort Study Danicopan - Paroxysmal Nocturnal Hemoglobinuria, PNH | Active not recruiting | Alexion Pharmaceuticals, Inc. | 50 | 2025-08-18 | 2026-02-17 | |
| Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis Danicopan - Paroxysmal Nocturnal Hemoglobinuria, PNH | Phase 3 | Recruiting | Alexion Pharmaceuticals, Inc. | 6 | 2025-08-11 | 2025-12-23 |
| A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH Danicopan - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Active not recruiting | Alexion Pharmaceuticals, Inc. | 80 | 2022-10-28 | 2026-06-18 |
| A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Danicopan, Placebo - Geographic Atrophy | Phase 2 | Terminated | Alexion Pharmaceuticals, Inc. | 365 | 2021-08-23 | 2025-09-05 |
| ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19 Danicopan, Placebo, Remdesivir - COVID-19 | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 201 | 2021-08-03 | 2023-06-08 |
| Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA) Danicopan, Placebo, C5 Inhibitor - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 86 | 2020-12-16 | 2025-05-04 |
| Study of the Metabolism of Danicopan in Healthy Adults Danicopan: Powder-In-Capsule 1, Danicopan: Powder-In-Capsule 2, Danicopan: Tablet - Healthy | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 24 | 2020-10-20 | 2022-04-15 |
| Study of Danicopan in Participants of Japanese Descent Danicopan - Healthy | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 9 | 2020-08-17 | 2021-02-15 |
| A Study of the Effects of Food and Age on Danicopan Danicopan - Healthy | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 27 | 2020-02-21 | 2023-01-13 |
| A Drug Interaction Study of Danicopan Danicopan, Warfarin, Bupropion - Healthy | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 52 | 2019-07-28 | 2021-01-14 |
| A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults Danicopan, Cyclosporine, Tacrolimus - Healthy | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 72 | 2018-07-27 | 2021-11-05 |
| A Study of the Cardiac Effects of Danicopan in Healthy Adults Danicopan, Moxifloxacin-matching Placebo, Danicopan-matching placebo - Healthy | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 33 | 2018-07-26 | 2021-08-23 |
| A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471 Danicopan - C3 Glomerulonephritis, C3 Glomerulopathy | Phase 2 | Terminated | Alexion Pharmaceuticals, Inc. | 22 | 2018-06-20 | 2023-08-21 |
| A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G) Danicopan, Placebo - C3 Glomerulopathy, C3 Glomerulonephritis | Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 13 | 2018-06-12 | 2022-10-14 |
| Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab Danicopan, Eculizumab - Paroxysmal Nocturnal Hemoglobinuria (PNH) | Phase 2 | Completed | Alexion Pharmaceuticals, Inc. | 12 | 2018-05-08 | 2023-12-12 |
| Study of Danicopan in Participants With Hepatic Impairment Danicopan - Hepatic Impairment | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 16 | 2018-05-01 | 2021-08-20 |
| Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction Danicopan - Healthy, Renal Dysfunction | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 16 | 2018-01-24 | 2021-06-23 |
| A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants Danicopan Modified Release Prototype 1, Danicopan Modified Release Prototype 2, Danicopan Modified Release Prototype 3 - Healthy | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 14 | 2017-12-01 | 2021-08-20 |
| Study of Radiolabeled Danicopan in Healthy Male Participants [14C]-Danicopan - Healthy | Phase 1 | Completed | Alexion Pharmaceuticals, Inc. | 8 | 2017-09-14 | 2021-05-17 |
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Hemoglobinuria, Paroxysmal (9) · Hemolysis (4) · Glomerulonephritis, Membranoproliferative (3) · Hemoglobinuria (2) · Anemia (1) · COVID-19 (1) · Geographic Atrophy (1) · Renal Insufficiency (1)
Alexion Pharmaceuticals, Inc. (27) · National Institute of Allergy and Infectious Diseases (NIAID) (1)
United States (16) · Italy (8) · United Kingdom (8) · New Zealand (7) · South Korea (5) · Australia (4) · France (4) · Canada (3) · Czechia (3) · Japan (3) · Netherlands (3) · Spain (3) · Belgium (2) · Brazil (2) · Germany (2)
PMID 36423588, PMID 31573880, PMID 33121236, PMID 34314483, PMID 37314061, PMID 38030318, PMID 39700502, PMID 41124654
2017 (4), 2016 (3), 2019 (1)