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Fabhalta iptacopan APPROVED
Drug Profile
ModalitySmall molecule
RouteOral
Therapy AreaImmunology
Launch2023-12-05
US LOE2038-12-05
Peak Sales Est$3000M
Formulations[{"id":"fabhalta-oral","doses":"100mg, 200mg capsules","route":"Oral","setting":"PATIENT_SELF","freq
Companies
NVS (ORIGINATOR)100%
Mechanism: Complement factor B inhibitor
Expert: Oral inhibitor of complement factor B, blocking alternative pathway activation
Everyday: Blocks part of the immune system that attacks healthy cells
Targets: ["FACTOR B"]
Revenue History
PeriodRevenue ($M)
2024$180M
2025$420M
Q4 2024$65M
Q4 2025$130M
Programs (3)
IndicationStageKey StudyRegional Status
PNHAPPROVEDAPPLY-PNH[{"stage":"APPROVED","region":"US","approval_date":"2023-12"}]
C3GPHASE3APPEAR-C3G[]
IgANAPPROVEDAPPLAUSE-IgAN[{"stage":"APPROVED","region":"US","approval_date":"2024-08"}]
Upcoming Catalysts (1)
Fabhalta - IgAN - Full Approval Data H2 2026
Notes
Factor B inhibitor for PNH/C3G. First oral complement inhibitor.
Data from Supabase · Updated 2026-03-24