Treats paroxysmal nocturnal hemoglobinuria (PNH). Sold as Fabhalta. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Iptacopan Hydrochloride (sold as Fabhalta), first approved Dec 5, 2023, with 3 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Fabhalta | Part D | $86.7M | +167% | 263 |
| Program | Updated |
|---|---|
| Fabhalta REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled | Jul 16, 2026 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan for Adult Patients With PNH in ChinaParoxysmal Nocturnal Hemoglobinuria · Novartis Pharmaceuticals | — | Recruiting | Apr 17, 2025 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Novartis