MedPath

Danicopan

Generic Name
Danicopan
Brand Names
Voydeya
Drug Type
Small Molecule
Chemical Formula
C26H23BrFN7O3
CAS Number
1903768-17-1
Unique Ingredient Identifier
JM8C1SFX0U
Background

Danicopan is under investigation in clinical trial NCT03459443 (A Proof of Concept Study for a 12 Month Treatment in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)).

Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis

Phase 3
Recruiting
Conditions
Paroxysmal Nocturnal Hemoglobinuria
PNH
Extravascular Hemolysis
Interventions
First Posted Date
2024-06-07
Last Posted Date
2025-03-07
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
6
Registration Number
NCT06449001
Locations
🇫🇷

Research Site, Paris, France

Danicopan Early Access Program

Conditions
Paroxysmal Nocturnal Hemoglobinuria
PNH
Extravascular Hemolysis
First Posted Date
2023-08-09
Last Posted Date
2025-04-17
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Registration Number
NCT05982938

Potential Drug Interaction Between ALXN2040 and Rosuvastatin

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2023-02-01
Last Posted Date
2023-04-14
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
20
Registration Number
NCT05708573
Locations
🇺🇸

Clinical Trial Site, Baltimore, Maryland, United States

A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH

Phase 3
Active, not recruiting
Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
First Posted Date
2022-05-25
Last Posted Date
2025-04-06
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
80
Registration Number
NCT05389449
Locations
🇬🇧

Research Site, London, United Kingdom

A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2021-11-05
Last Posted Date
2021-11-05
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
72
Registration Number
NCT05109390
Locations
🇺🇸

Clinical Trial Site, Tempe, Arizona, United States

A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Phase 2
Completed
Conditions
Geographic Atrophy
Interventions
Drug: Placebo
First Posted Date
2021-08-25
Last Posted Date
2025-02-07
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
365
Registration Number
NCT05019521
Locations
🇬🇧

Research Site, Southampton, United Kingdom

A Study of the Cardiac Effects of Danicopan in Healthy Adults

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Moxifloxacin-matching Placebo
Drug: Danicopan-matching placebo
First Posted Date
2021-08-23
Last Posted Date
2021-08-23
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
33
Registration Number
NCT05016206
Locations
🇺🇸

Clinical Trial Site, Tempe, Arizona, United States

ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19

Phase 2
Completed
Conditions
COVID-19
Interventions
First Posted Date
2021-08-03
Last Posted Date
2023-06-08
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
201
Registration Number
NCT04988035
Locations
🇺🇸

Great Lakes Clinical Trials, Chicago, Illinois, United States

🇺🇸

Nuvance Health Danbury Hospital - Infectious Disease, Danbury, Connecticut, United States

🇺🇸

Kern Medical Center, Bakersfield, California, United States

and more 36 locations

Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants

First Posted Date
2021-06-25
Last Posted Date
2021-06-25
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
26
Registration Number
NCT04940559
Locations
🇳🇿

Clinical Trial Site, Auckland, New Zealand

Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction

Phase 1
Completed
Conditions
Healthy
Renal Dysfunction
Interventions
First Posted Date
2021-06-23
Last Posted Date
2021-06-23
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
16
Registration Number
NCT04935294
Locations
🇺🇸

Clinical Trial Site, Saint Paul, Minnesota, United States

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