NDAORALCAPSULEPriority Review
Approved
Dec 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FABHALTA (iptacopan) is an oral small-molecule Factor B inhibitor approved by the FDA on December 5, 2023. It targets the alternative complement pathway, a key driver of inflammation in rare kidney and blood disorders. The drug represents a novel oral approach to complement inhibition in conditions previously limited to IV biologics.
Growth14.8 years to LOE
Early-stage growth product with zero reported competitive pressure; commercial team is likely small but expanding as market awareness builds.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain
Started Sep 2026
35 enrolled
Complement 3 Glomerulopathy
Safety and Efficacy of Iptacopan in Patients With High-Risk Transplantation-Associated Thrombotic Microangiopathy
Started Aug 2026
30 enrolled
Thrombotic MicroangiopathyHematopoietic Stem Cell Transplantation (HSCT)
A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
Started Jun 2026
21 enrolled
Paroxysmal Nocturnal HemoglobinuriaC3 Glomerulopathy
IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and/or Atrasentan Using Primary Data Collection
Started May 2026
80 enrolled
IgA Nephropathy
REAL-CARE: Real-world Effectiveness of Iptacopan in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria
Started Jan 2026
50 enrolled
Paroxysmal Nocturnal Hemoglobinuria (PNH)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.