Rosiglitazone
As of the edition of 20 October 2026, Rosiglitazone is a small molecule: marketed, first approved in 1999 (US); acts on PPARG; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1999
- Kind
- Small molecule
- Brand name
- Avandia
- First approved
- 25 May 1999 (US)
- Approvals on record
- 13 in 1 region
- Holder of the most recent approval
- SB PHARMCO PUERTO RICO INC; 2 holders in all
- Withdrawn from market
- 11 July 2015 (in some regions)
- Registered trials
- 147, 23 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Heart and blood vessels; Nervous system; Urinary and reproductive; 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.
Companies that need a new molecule because of this drug
1 company on route B and 1 company on route A because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Rosiglitazone.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Companies on route A for this drug
In the product1 company is on route A because of Rosiglitazone.
See the 1 company on route A for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PPARG | Peroxisome proliferator-activated receptor gamma | P37231 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 29 | 20 | 0 | 5 |
| Phase 1 | 18 | 17 | 0 | 1 |
| Phase 2 | 29 | 20 | 1 | 4 |
| Phase 3 | 43 | 32 | 0 | 8 |
| Phase 4 | 28 | 22 | 0 | 5 |
| All trials | 147 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator and Lead sponsor of trials | 1999 to now |
| Woodward Pharma | Acquired holder | 2021 to now |