PharmaRadar360

PharmaRadar360

HematologyDrug intelligence

Fabhalta

Iptacopan

Factor B inhibitor (alternative complement pathway). Developed by Novartis. Clinical, regulatory, and source evidence are connected below.

Company
Novartis
Target / MOA
Factor B · CFB
Aliases
Fabhalta
Signals
20
Clinical trials
20
Approvals
0
Evidence sources
20

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

Phase 2 · TERMINATED · Novartis Pharmaceuticals

clinical trialClinicalTrials.gov

Iptacopan in Patients With ANCA Associated Vasculitis

Phase 2 · ACTIVE_NOT_RECRUITING · Novartis Pharmaceuticals

clinical trialClinicalTrials.gov

A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain

N/A · RECRUITING · Novartis Pharmaceuticals

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Fabhalta · NDA218276 · label version 6, effective Jul 16, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Paroxysmal Nocturnal Hemoglobinuria FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 1.2 Immunoglobulin A Nephropathy FABHALTA is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. 1.3 Complement 3 Glomerulopathy FABHALTA is indicated for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.

European Union (EMA)

Fabhalta · EMEA/H/C/005764 · Authorised, authorised May 17, 2024 (Commission decision C(2024) 3465) · EPAR

Paroxysmal nocturnal haemoglobinuria Fabhalta is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Complement 3 glomerulopathy Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated (see section 5.1).

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

NDA218276 · NOVARTIS · first approved Dec 5, 2023

3 efficacy supplements approved

European Union

  • Fabhalta: Authorised since May 17, 2024

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

NDA218276 (Orange Book)

8 listed patents, latest expiry Jul 15, 2041
  • US 10093663 · expires Jul 14, 2034 · U-4161, U-3980
  • US 9682968 · expires Jul 14, 2034 · drug substance, drug product
  • US 11723901 · expires Aug 30, 2038 · U-3980
  • US 12285422 · expires Aug 30, 2038 · U-4181
  • US 12384758 · expires May 17, 2041 · U-3980, U-4161
  • US 11603363 · expires May 25, 2041 · drug substance, drug product
  • US 11951101 · expires Jul 15, 2041 · U-3895
  • US 12453726 · expires Jul 15, 2041 · U-4300

Exclusivity: I-949 until Aug 7, 2027; I-963 until Mar 20, 2028; NCE until Dec 5, 2028; ODE-456 until Dec 5, 2030; ODE-524 until Mar 20, 2032 · Orange Book entry

Generics and biosimilars

The Orange Book lists no approved generic (ANDA).

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

Fabhalta label

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA FABHALTA, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b [see Warnings and Precautions (5.1)] . Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. • Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of FABHALTA, unless the risks of delaying therapy with FABHALTA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria. • Patients receiving FABHALTA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FABHALTA REMS [see Warnings and Precautions (5.2)] .

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 20 linked records.

Phase 2TERMINATEDNCT05268289

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

Novartis Pharmaceuticals · Updated Oct 15, 2026

Phase 2ACTIVE NOT RECRUITINGNCT06388941

Iptacopan in Patients With ANCA Associated Vasculitis

Novartis Pharmaceuticals · Updated Oct 15, 2026

N/ARECRUITINGNCT07598448

A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain

Novartis Pharmaceuticals · Updated Oct 7, 2026

Phase 3RECRUITINGNCT04557462

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Novartis Pharmaceuticals · Updated Oct 5, 2026

Phase 2ACTIVE NOT RECRUITINGNCT05230537

A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration

Novartis Pharmaceuticals · Updated Sep 22, 2026

Phase 3RECRUITINGNCT06994845

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

Novartis Pharmaceuticals · Updated Sep 9, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

No regulatory event is available in this snapshot.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 15, 202620
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.