Iptacopan
As of the edition of 20 October 2026, Iptacopan is a small molecule: marketed, first approved in 2023 (US); acts on CFB; US protection ends in 2041.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Fabhalta
- First approved
- 5 December 2023 (US)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 31, 2 stopped early
- Disease areas
- Blood and lymph; Pregnancy and women's health; Urinary and reproductive; Immune system; Nervous system; Cancer
US protection
US protection ends in 2041.
The last listed US drug-substance patent ends in 2041. The application that gives this date is held by Novartis.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product7 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 7 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Iptacopan.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CFB | Complement factor B | P00751 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 0 | 4 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 10 | 5 | 3 | 2 |
| Phase 3 | 15 | 5 | 10 | 0 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2022 to now |