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 a Single Dose of Danicopan in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2021-05-17
Last Posted Date
2021-05-17
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
44
Registration Number
NCT04889677
Locations
🇳🇿

Clinical Trial Site, Auckland, New Zealand

Study of Multiple Doses of Danicopan in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2021-05-17
Last Posted Date
2021-05-17
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
45
Registration Number
NCT04889690
Locations
🇳🇿

Clinical Trial Site, Auckland, New Zealand

A Drug Interaction Study of Danicopan

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Ethinyl Estradiol/Norethindrone
First Posted Date
2021-01-14
Last Posted Date
2021-01-14
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
52
Registration Number
NCT04709094
Locations
🇺🇸

Clinical Study Site, Tempe, Arizona, United States

A Study of the Effects of Food and Age on Danicopan

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2020-09-16
Last Posted Date
2023-01-13
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
27
Registration Number
NCT04551599
Locations
🇺🇸

Clinical Trial Site, Tempe, Arizona, United States

Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

Phase 3
Completed
Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
First Posted Date
2020-07-14
Last Posted Date
2025-05-04
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
86
Registration Number
NCT04469465
Locations
🇬🇧

Research Site, London, United Kingdom

Study of Danicopan in Participants of Japanese Descent

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2020-06-30
Last Posted Date
2021-02-15
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
9
Registration Number
NCT04451434
Locations
🇦🇺

Clinical Study Site, Brisbane, Australia

Study of Danicopan in Participants With Hepatic Impairment

Phase 1
Completed
Conditions
Hepatic Impairment
Interventions
First Posted Date
2018-06-13
Last Posted Date
2021-08-20
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
16
Registration Number
NCT03555539
Locations
🇺🇸

Clinical Trial Site, Orlando, Florida, United States

Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab

Phase 2
Completed
Conditions
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Interventions
First Posted Date
2018-03-21
Last Posted Date
2023-12-12
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
12
Registration Number
NCT03472885
Locations
🇬🇧

Clinical Study Site, London, United Kingdom

A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471

Phase 2
Terminated
Conditions
C3 Glomerulopathy
Immune Complex Membranoproliferative Glomerulonephritis
IC-MPGN
C3 Glomerulonephritis
Dense Deposit Disease
Interventions
First Posted Date
2018-03-09
Last Posted Date
2023-08-21
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
22
Registration Number
NCT03459443
Locations
🇳🇱

Clinical Study Site, Nijmegen, Netherlands

A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants

First Posted Date
2017-12-27
Last Posted Date
2021-08-20
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
14
Registration Number
NCT03384186
Locations
🇬🇧

Clinical Trial Site, Ruddington, Nottingham, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath