Fabhalta (iptacopan)
An approved treatment for IgA Nephropathy, C3 Glomerulopathy and Paroxysmal Nocturnal Hemoglobinuria.
The same compound appears under different names depending on the context. Here is how to identify Iptacopan wherever you encounter it, plus the key facts at a glance.
- Generic name
- Iptacopan
- Brand name
- Fabhalta
- Development code
- LNP023
- Drug class
- Complement factor B inhibitor
- Manufacturer
- Novartis
- How it's taken
- Fabhalta is taken as a 200 mg capsule by mouth twice daily, with or without food.
An oral medication that blocks complement factor B, a key immune protein that overreacts in both IgA nephropathy and C3 glomerulopathy. In IgAN, the prespecified interim analysis showed iptacopan reduced proteinuria by 38.3% versus placebo (44% reduction with iptacopan vs 9% with placebo). The FDA granted accelerated approval for IgAN in August 2024, converted it to traditional (full) approval on July 16, 2026 based on 2-year kidney function data, and approved iptacopan for C3 glomerulopathy on March 20, 2025, making it one of the first targeted therapies for that disease.
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Where Iptacopan fits
First oral complement inhibitor for IgA nephropathy, targeting the alternative complement pathway. Represents a new mechanistic approach beyond immunosuppression and RAS blockade.
How Iptacopan works
Fabhalta targets the complement system, a part of your immune system that normally attacks bacteria but also mistakenly damages your kidneys in IgA nephropathy. Iptacopan blocks factor B, a key component that amplifies this attack. It's like shutting down one of the main attack routes your immune system is using against your own kidneys.
Mechanism: Selective oral inhibitor of complement factor B, preventing activation of the alternative complement pathway that amplifies kidney inflammation
Side effects and safety
Fabhalta carries a boxed warning for serious and life-threatening infections caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b. Patients must complete or update vaccinations against these bacteria at least 2 weeks before the first dose, and the drug is only available through a restricted program (the FABHALTA REMS). Get medical care right away for signs of serious infection. In the IgA nephropathy trial, the most common side effects more frequent than with placebo were abdominal pain, dizziness and nausea, and serious infections with encapsulated bacteria occurred in 3 patients (1.2%) on Fabhalta and none on placebo. The label also advises periodic cholesterol and lipid checks. People with PNH who stop Fabhalta need close monitoring for at least 2 weeks for signs of red blood cell breakdown (hemolysis), which can include blood clots, stroke or heart attack, so talk to your doctor before stopping.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Iptacopan
Fabhalta is taken as a 200 mg capsule by mouth twice daily, with or without food. Vaccinations against encapsulated bacteria must be completed or updated at least 2 weeks before the first dose, and the drug is only available through the FABHALTA REMS program. Treatment is ongoing to maintain benefits.
Availability and cost
Only available as the brand-name product.
First-in-class oral complement factor B inhibitor. Novel targeted therapy in a rare kidney disease with limited treatment options.
Help paying for Fabhalta
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Co-Pay Plus: eligible privately insured patients may pay as little as $0; up to $20,000 a year for Fabhalta plus up to $1,000 for required vaccinations. Not for government insurance.
For: private insurance · source - Bridge or quick-start supply
Privately insured patients with a prior authorization or initial denial may get up to 12 months of Fabhalta free while coverage is pursued.
For: private insurance · source - Insurance and case manager help
A dedicated Novartis Patient Support team helps with coverage and ongoing support. Mon-Fri 8 AM-8 PM ET.
The official page does not say who qualifies. Ask the program. · source - Free medicine program
Novartis Patient Assistance Foundation provides Fabhalta free to eligible patients who are uninsured or have government insurance and meet income limits.
For: no insurance, Medicare, Medicaid · source
Good to know: Free drug is through the separate Novartis Patient Assistance Foundation (1-800-277-2254); income limits apply.
- From a charity · NORD RareCareIgA Nephropathy Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · NORD RareCareIgA Nephropathy Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · The Assistance FundImmunoglobulin A Nephropathy (IgAN) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.” - From a charity · IgA Nephropathy FoundationIgA Nephropathy Foundation Patient Aid Grant fundApply directly
Pays for: Out-of-pocket medical costs and non-medical costs of treatment such as childcare or transportation (Foundation membership required).
The foundation says: “Status not shown on page” - From a charity · NORD RareCarePNH Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · NORD RareCarePNH Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · NORD RareCareParoxysmal Nocturnal Hemoglobinuria (PNH) Emergency Relief fundOpen
Pays for: Emergency relief.
The foundation says: “Accepting Applications” - From a charity · The Assistance FundParoxysmal Nocturnal Hemoglobinuria (PNH) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.” - From a charity · TotalAssist (formerly PAN Foundation)Paroxysmal Nocturnal Hemoglobinuria fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $9,500 per year. Requires health insurance (any kind).
- From a charity · Aplastic Anemia & MDS International FoundationPNH Patient Travel Assistance Fund fundApply directly
Pays for: Travel to a PNH specialist or second opinion (patient plus one companion), up to $800 per year.
The foundation says: “Status not shown on page”
How IgA nephropathy treatments compare
As of 2026, five FDA-approved medicines are available for IgA nephropathy, plus active investigational programs. The right choice depends on your proteinuria level, kidney function (eGFR), prior treatments, biopsy findings, and personal preferences around oral pills versus injections. Your nephrologist will help match a treatment to your specific situation. This chart compares the practical differences between options.
5 FDA-approved iga nephropathy treatments are available: Tarpeyo (budesonide (delayed release), approved 2021); Filspari (sparsentan, approved 2023); Fabhalta (iptacopan, approved 2024); Vanrafia (atrasentan, approved 2025); Voyxact (sibeprenlimab, approved 2025); BHV-1400 (BHV-1400, Phase 1). Tarpeyo is typically used as standard corticosteroid considerations apply (immunosuppression, infection risk, glucose changes); first disease-modifying therapy approved specifically for igan.
| Drug | What makes it different | How it works | How it’s given | How often | Where you get it | Safety highlights | FDA approved |
|---|---|---|---|---|---|---|---|
Tarpeyo budesonide (delayed release) | Targets the disease at its source in the gut | Targeted-release corticosteroid that suppresses Gd-IgA1 antibody production in gut-associated lymphoid tissue (Peyer’s patches) | Oral capsule (taken on an empty stomach) | Once daily | Home (specialty pharmacy delivery) | Standard corticosteroid considerations apply (immunosuppression, infection risk, glucose changes); first disease-modifying therapy approved specifically for IgAN | 2021 |
Filspari sparsentan | Dual ETA + AT1 receptor block in one pill (non-immunosuppressive) | Dual endothelin-A and angiotensin-II AT1 receptor antagonist that reduces glomerular pressure and proteinuria | Oral tablet (REMS program) | Once daily | Home (REMS-certified specialty pharmacy) | Boxed warnings for hepatotoxicity and major birth defects; monthly liver enzyme monitoring; confirmed contraception required (pregnancy contraindicated) | 2023 |
Fabhalta iptacopan You are here | First oral complement inhibitor for IgAN | Selective oral inhibitor of complement factor B that blocks alternative-pathway activation driving kidney inflammation | Oral capsule (REMS program) | Twice daily | Home (REMS-certified specialty pharmacy) | Boxed warning for serious encapsulated-bacteria infections; meningococcal, pneumococcal, and Hib vaccinations required at least 2 weeks before starting | 2024 |
Vanrafia atrasentan | Selective ETA blocker, no REMS or routine liver monitoring required | Selective endothelin-A receptor antagonist that reduces glomerular hypertension and fibrosis | Oral tablet (no REMS required) | Once daily | Home (specialty pharmacy delivery) | Boxed warning for major birth defects (pregnancy contraindicated); contraception required during and for 2 weeks after treatment; warnings include hepatotoxicity, fluid retention, and decreased sperm counts | 2025 |
Voyxact sibeprenlimab | First APRIL antagonist; self-injected at home once a month | Monoclonal antibody that blocks APRIL signaling, reducing B-cell production of pathogenic Gd-IgA1 antibodies | Subcutaneous injection (self-administered, no REMS required) | Every 4 weeks | Home (after training from care team) | Routine vaccinations should be up-to-date before starting; live vaccines avoided during treatment; immunoglobulin levels are monitored periodically | 2025 |
BHV-1400 BHV-1400 | Selectively removes only the disease-driving antibody; spares normal immunity | TRAP degrader that selectively binds Gd-IgA1 and routes it to the liver for clearance, sparing normal antibodies | Subcutaneous injection | Phase 1 expansion cohort enrolling IgAN patients; pivotal regimen TBD | Clinical trial site only (not commercially available) | Investigational — Phase 1 healthy-volunteer single-dose data showed up to 81% Gd-IgA1 reduction; spares normal IgA, IgG, IgE, and IgM; pivotal trial planned for 2026 | Phase 1 |
This chart compares FDA-approved IgA nephropathy treatments and one advanced investigational program (BHV-1400). It is not medical advice. All approved IgAN therapies require background renin-angiotensin system (RAS) blockade with an ACE inhibitor or ARB, and many patients also take an SGLT2 inhibitor. Treatment selection should be made with your nephrologist based on your kidney function, biopsy results, proteinuria level, comorbidities, and prior therapies.
Clinical trial results
The Phase 3 APPLAUSE-IgAN trial enrolled approximately 518 patients overall. Over 2 years, kidney function (eGFR) declined 3.0 points a year with iptacopan versus 5.7 on placebo, a 48% slower decline, and the FDA granted traditional approval on July 16, 2026. Earlier, the prespecified interim analysis on the first 250 patients (125 per arm) at 9 months showed iptacopan reduced proteinuria by 38.3% versus placebo (a 44% reduction from baseline with iptacopan vs 9% with placebo, p<0.0001). FDA granted accelerated approval in August 2024 based on this interim data.
Development history
Novartis developed iptacopan as the first complement factor B inhibitor for IgA nephropathy. The FDA granted accelerated approval in August 2024 based on the rapid reduction in proteinuria, and granted traditional (full) approval on July 16, 2026, after 2-year data showed iptacopan slowed kidney function decline.
Explore IgA Nephropathy and C3 Glomerulopathy and Paroxysmal Nocturnal Hemoglobinuria trials
Other IgA Nephropathy & C3 Glomerulopathy treatments
Iptacopan in Trial Friend News and Guides
- 6 Approved Drugs for IgA Nephropathy and What Their Labels Actually PromiseSeptember 16, 2026
- A Quiet Crisis in Rare Disease Research: Trial Enrollment Is Slowing Just as Treatments Start WorkingApril 13, 2026
- From Zero Treatments to 5 in 3 Years: The IgA Nephropathy Breakthrough Nobody Saw ComingMarch 31, 2026
Common questions about Iptacopan
▸What is Iptacopan (Fabhalta)?
An oral medication that blocks complement factor B, a key immune protein that overreacts in both IgA nephropathy and C3 glomerulopathy. In IgAN, the prespecified interim analysis showed iptacopan reduced proteinuria by 38.3% versus placebo (44% reduction with iptacopan vs 9% with placebo). The FDA granted accelerated approval for IgAN in August 2024, converted it to traditional (full) approval on July 16, 2026 based on 2-year kidney function data, and approved iptacopan for C3 glomerulopathy on March 20, 2025, making it one of the first targeted therapies for that disease.
▸How does Iptacopan work?
Fabhalta targets the complement system, a part of your immune system that normally attacks bacteria but also mistakenly damages your kidneys in IgA nephropathy. Iptacopan blocks factor B, a key component that amplifies this attack. It's like shutting down one of the main attack routes your immune system is using against your own kidneys.
▸What are the side effects of Iptacopan?
Fabhalta carries a boxed warning for serious and life-threatening infections caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b. Patients must complete or update vaccinations against these bacteria at least 2 weeks before the first dose, and the drug is only available through a restricted program (the FABHALTA REMS). Get medical care right away for signs of serious infection. In the IgA nephropathy trial, the most common side effects more frequent than with placebo were abdominal pain, dizziness and nausea, and serious infections with encapsulated bacteria occurred in 3 patients (1.2%) on Fabhalta and none on placebo. The label also advises periodic cholesterol and lipid checks. People with PNH who stop Fabhalta need close monitoring for at least 2 weeks for signs of red blood cell breakdown (hemolysis), which can include blood clots, stroke or heart attack, so talk to your doctor before stopping.
▸How is Iptacopan taken?
Fabhalta is taken as a 200 mg capsule by mouth twice daily, with or without food. Vaccinations against encapsulated bacteria must be completed or updated at least 2 weeks before the first dose, and the drug is only available through the FABHALTA REMS program. Treatment is ongoing to maintain benefits.
▸Is Iptacopan FDA approved?
Yes, Iptacopan (Fabhalta) is FDA approved (2023) for the treatment of IgA Nephropathy and C3 Glomerulopathy and Paroxysmal Nocturnal Hemoglobinuria.
▸What is complement factor B and why block it?
Complement factor B is a key component of the alternative complement pathway, part of the immune system that gets overactivated in IgA nephropathy and amplifies kidney inflammation. By blocking factor B, iptacopan shuts down this attack pathway to protect the kidneys.
▸What did the APPLAUSE-IgAN trial show?
APPLAUSE-IgAN enrolled approximately 518 patients overall. The prespecified interim analysis on the first 250 patients at 9 months showed iptacopan reduced proteinuria by 38.3% versus placebo (44% reduction from baseline with iptacopan vs 9% with placebo, p<0.0001). FDA granted accelerated approval in August 2024 based on this interim data. The final 2-year results showed kidney function declined 3.0 points a year with Fabhalta versus 5.7 on placebo, and the FDA granted traditional approval on July 16, 2026.
▸Is iptacopan also approved for other conditions?
Yes. Fabhalta was first approved in December 2023 for adults with paroxysmal nocturnal hemoglobinuria (PNH), a blood disorder. It is also approved for adults with IgA nephropathy and for adults with C3 glomerulopathy, both kidney diseases involving complement overactivation.
▸How is iptacopan taken?
Iptacopan (Fabhalta) is taken as a capsule by mouth twice daily, with or without food. Treatment is ongoing to maintain the benefits of complement inhibition.
▸Were there infection concerns with iptacopan?
Yes. Fabhalta has a boxed warning because it raises the risk of serious, life-threatening infections from encapsulated bacteria such as pneumococcus and meningococcus. Vaccinations must be completed or updated at least 2 weeks before starting, prescribers must enroll in the FABHALTA REMS program, and vaccination does not remove the risk entirely. In the IgA nephropathy trial, 3 patients (1.2%) on Fabhalta and none on placebo had serious infections with encapsulated bacteria. Seek medical care right away for fever, severe headache, stiff neck or other signs of serious infection.
▸What patient support is available for Fabhalta?
Novartis Patient Support provides copay assistance plus a bridge program for coverage delays. The Novartis Patient Assistance Foundation may provide medication at no cost for eligible patients who are uninsured or have government insurance and cannot afford their costs.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Novartis · 2026-07-17. Novartis Fabhalta (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN. https://www.novartis.com/news/media-releases/novartis-fabhalta-iptacopan-receives-fda-traditional-approval-first-and-only-complement-inhibitor-significantly-slow-kidney-function-decline-primary-igan