Pegcetacoplan
As of the edition of 20 October 2026, Pegcetacoplan is a protein: marketed, first approved in 2021 (US); acts on C3; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Protein
- Brand name
- Empaveli
- First approved
- 14 May 2021 (US)
- Approvals on record
- 8 in 6 regions
- Holder of the most recent approval
- PINT PHARMA PRODUTOS MEDICO-HOSPITALARES E FARMACEUTICOS LTDA; 5 holders in all
- Registered trials
- 32, 3 stopped early
- Disease areas
- Blood and lymph; Eye; Pregnancy and women's health; Urinary and reproductive; Immune system; Cancer
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Biogen.
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 product30 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Pegcetacoplan.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| C3 | Complement C3 | P01024 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 0 | 2 | 0 |
| Phase 1 | 6 | 4 | 1 | 1 |
| Phase 2 | 13 | 6 | 5 | 2 |
| Phase 3 | 9 | 8 | 1 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 32 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Biogen | Originator and Lead sponsor of trials | 2021 to now |
| Swedish Orphan Biovitrum | Applicant and Lead sponsor of trials | 2021 to now |