Celecoxib
As of the edition of 20 October 2026, Celecoxib is a small molecule: marketed, first approved in 1998 (US); acts on PTGS2; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2000
- Kind
- Small molecule
- Brand name
- Celebrex
- First approved
- 31 December 1998 (US)
- Approvals on record
- 15 in 4 regions
- Holder of the most recent approval
- Carwin Pharmaceutical Associates; 9 holders in all
- Withdrawn from market
- 28 November 2008 (in some regions)
- Registered trials
- 418, 84 stopped early
- Disease areas
- Cancer; Digestive system; Bones, joints and muscles; Lungs and airways; Skin and connective tissue; Nervous system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
KOWA PHARMACEUTICALS AMERICA INC holds a later exclusivity on its own new formulation or combination product, ending 2030; it does not protect the original drug.
This is the US only.
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 Celecoxib.
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 |
|---|---|---|
| PTGS2 | Prostaglandin G/H synthase 2 | P35354 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 46 | 24 | 3 | 10 |
| Phase 1 | 66 | 44 | 5 | 15 |
| Phase 2 | 178 | 103 | 20 | 40 |
| Phase 3 | 65 | 46 | 3 | 10 |
| Phase 4 | 63 | 43 | 5 | 9 |
| All trials | 418 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Applicant and Lead sponsor of trials | 2010 to now |
| Dr. Reddy's | Later holder and Lead sponsor of trials | 2015 to now |
| Viatris | Acquired holder | 2021 to now |
| Scilex Pharmaceuticals | Acquired holder | 2024 to now |
| Carwin Pharmaceutical Associates | Acquired holder | 2025 to now |