Fabhalta
(Danicopan)Phase 3Small molecule
AstraZenecaDanicopan is used to prevent blood cell destruction in patients with a rare blood disorder called paroxysmal nocturnal hemoglobinuria (PNH), helping protect red blood cells from being attacked by the immune system.[1] Fabhalta is currently being investigated across 2 indications[3], with its most advanced program in Phase 3.[1]
Fabhalta is one of 49 small molecule programs targeting Hemolysis. It is currently in Phase 3.
2
Indications
26
Total Trials
4
Active Trials
48
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[3][1]
Competition
Competitive Landscape
130 competitors in Safety and Efficacy
#DrugCompanyPhaseTrials
1Avastin
RochePhase 3
Actemra
RochePhase 3
Rayos
RRoxane Laboratories
Phase 3
Humira
RRanbaxy Laboratories Limited
Phase 3
Empaveli
Apellis PharmaceuticalsPhase 3
CAB LA
GSKPhase 3
Tagrisso
AstraZenecaPhase 2
B/F/TAF
GileadPhase 3
Eloxatin
TevaPhase 2
Nuzyra
PParatek Pharmaceuticals Inc
Phase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Paroxysmal Nocturnal Hemoglobinuria4 trials
ART3 trials
Interaction2 trials
15 more indications
C3 Glomerulopathy (C3G)1 trial
IC-MPGN1 trial
Drug Interactions1 trial
COVID-191 trial
ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04988035·201 enrolled
Safety and Efficacy1 trial
Age-Related Macular Degeneration1 trial
Hemolysis1 trial
Treatment1 trial
Function1 trial
Regulatory
FDA Approval Timeline[4]
Mar 29, 2024
VOYDEYA
NDA NDA218037
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Danicopan. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Complement Factor D Inhibitor[2]
- Modality
- Small molecule[2]
- Highest Phase
- Phase 3[1]
- Company