Telaprevir
As of the edition of 20 October 2026, Telaprevir is a small molecule: marketed, first approved in 2011 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Incivek
- First approved
- 23 May 2011 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Mitsubishi Tanabe Pharma; 2 holders in all
- Withdrawn from market
- 22 September 2016 (in some regions)
- Registered trials
- 79, 12 stopped early
- Disease areas
- Digestive system; Infections; Urinary and reproductive; Immune system; Blood and lymph; Cancer
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 4 | 0 | 0 |
| Phase 1 | 23 | 23 | 0 | 0 |
| Phase 2 | 23 | 17 | 0 | 5 |
| Phase 3 | 24 | 20 | 0 | 4 |
| Phase 4 | 4 | 1 | 0 | 3 |
| All trials | 79 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Vertex | Originator and Lead sponsor of trials | 2005 to now |
| Mitsubishi Tanabe Pharma | Applicant | 2011 to now |