FABHALTA

Growth

iptacopan

NDAORALCAPSULEPriority Review
Approved
Dec 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
29

Mechanism of Action

C3, generation of downstream effectors, and the amplification of the terminal pathway. In PNH, intravascular hemolysis (IVH) is mediated by the downstream membrane attack complex (MAC), while extravascular hemolysis (EVH) is facilitated by C3b opsonization. Iptacopan acts proximally in the…

Clinical Trials (5)

NCT07416162N/ANot Yet Recruiting

A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy

Started Jul 2026
21 enrolled
Paroxysmal Nocturnal HemoglobinuriaC3 Glomerulopathy
NCT07229235N/ANot Yet Recruiting

REAL-CARE: Real-world Effectiveness of Iptacopan in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria

Started Dec 2025
50 enrolled
Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT06994845Phase 3Recruiting

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN

Started Nov 2025
31 enrolled
Primary Immunoglobulin A Nephropathy (IgAN)
NCT06934967Phase 3Recruiting

Study to Assess the Pharmacokinetics, Safety, and Tolerability of Iptacopan in Pediatric PNH Patients

Started Oct 2025
12 enrolled
Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT07156149N/ARecruiting

Fabhalta Capsules Specified Drug-use Survey

Started Sep 2025
50 enrolled
C3 Glomerulopathy

Loss of Exclusivity

LOE Date
Jul 15, 2041
187 months away
Patent Expiry
Jul 15, 2041
Exclusivity Expiry
Dec 5, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
10093663
Jul 14, 2034
U-3980
9682968
Jul 14, 2034
SubstanceProduct
11723901
Aug 30, 2038
U-3980
12285422
Aug 30, 2038
U-4181
12384758
May 17, 2041
U-4161