Pioglitazone
As of the edition of 20 October 2026, Pioglitazone 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 2010
- Kind
- Small molecule
- Brand name
- Actos
- First approved
- 15 July 1999 (US)
- Approvals on record
- 24 in 3 regions
- Holder of the most recent approval
- Takeda; 2 holders in all
- Withdrawn from market
- 22 June 2021 (in some regions)
- Registered trials
- 323, 49 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Cancer; Heart and blood vessels; Urinary and reproductive; Digestive system
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
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 Pioglitazone.
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 |
|---|---|---|
| PPARG | Peroxisome proliferator-activated receptor gamma | P37231 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 49 | 34 | 3 | 7 |
| Phase 1 | 51 | 40 | 6 | 4 |
| Phase 2 | 83 | 47 | 9 | 19 |
| Phase 3 | 62 | 48 | 3 | 10 |
| Phase 4 | 78 | 50 | 5 | 9 |
| All trials | 323 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Acquired holder and Lead sponsor of trials | 1997 to now |
| Cheplapharm Arzneimittel | Applicant | 2000 to now |