Friday, July 10, 2026

Drug profile · INN

iptacopan hydrochloride

iptacopan hydrochloride (FABHALTA) is a complement factor b inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — iptacopan hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
4
Data quality
0.84

Quick answer

iptacopan hydrochloride (FABHALTA) is a complement factor b inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN iptacopan hydrochloride
Brand FABHALTA
Mechanism Complement factor B inhibitor
Target Complement factor B
Route ORAL
Formulation CAPSULE

Mechanism of action

Complement factor B inhibitor

Primary target: Complement factor B

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. CLNP023B12301 Phase 3 · Novartis India · complement 3 glomerulopathy
  2. IPTACOPAN HYDROCHLORIDE Phase 3 · Novartis India · Paroxysmal Nocturnal Hemoglobinuria (PNH)
  3. IPTACOPAN HYDROCHLORIDE, IPTACOPAN Approved · Novartis India · C3 Glomerulopathy or idiopathic immune-complex membranoproli
  4. iptacopan Unknown · First People's Hospital · Thrombotic Microangiopathy

Related & competitor drugs

  1. iptacopan Antineoplastic and immunomodulating agents (L04)
  2. iptacopan hydrochloride hydrate Complement factor B inhibitor

Frequently asked questions

What is iptacopan hydrochloride?

iptacopan hydrochloride (FABHALTA) is a complement factor b inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for iptacopan hydrochloride?

FABHALTA is a marketed brand name for iptacopan hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of iptacopan hydrochloride?

iptacopan hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.