Metformin
As of the edition of 20 October 2026, Metformin is a small molecule: marketed, first approved in 1960 (CH); acts on GPD2; 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 2010
- Kind
- Small molecule
- Brand name
- Glucophage
- First approved
- 22 March 1960 (CH)
- Approvals on record
- 138 in 7 regions
- Holder of the most recent approval
- Zydus Lifesciences Global Fze; 27 holders in all
- Withdrawn from market
- 22 July 2025 (in some regions)
- Registered trials
- 1,613, 167 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Cancer; Urinary and reproductive; Pregnancy and women's health; Skin and connective tissue
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.
AstraZeneca holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Metformin.
See the 4 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GPD2 | Glycerol-3-phosphate dehydrogenase, mitochondrial | P43304 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 231 | 127 | 31 | 18 |
| Phase 1 | 425 | 341 | 36 | 26 |
| Phase 2 | 325 | 154 | 60 | 67 |
| Phase 3 | 344 | 244 | 26 | 27 |
| Phase 4 | 288 | 189 | 24 | 29 |
| All trials | 1,613 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Applicant and Lead sponsor of trials | 1995 to now |
| Sanofi | Applicant and Lead sponsor of trials | 1995 to now |
| Bausch Health | Acquired holder | 1996 to now |
| Takeda | Later holder and Lead sponsor of trials | 2001 to now |
| Actavis | Later holder and Lead sponsor of trials | 2002 to now |
| Daiichi Sankyo | Later holder and Lead sponsor of trials | 2002 to now |
| Merck & Co. | Later holder and Lead sponsor of trials | 2003 to now |
| AstraZeneca | Later holder and Lead sponsor of trials | 2004 to now |
| Novartis | Later holder and Lead sponsor of trials | 2005 to now |
| Boehringer Ingelheim | Later holder and Lead sponsor of trials | 2005 to now |
| Cheplapharm Arzneimittel | Applicant | 2006 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 2007 to now |
| Dainippon Sumitomo Pharma | Applicant | 2010 to now |
| Santarus | Acquired holder | 2011 to now |
| Merck KGaA | Acquired holder and Lead sponsor of trials | 2012 to now |
| Sanwa Kagaku Kenkyusho | Later holder | 2018 to now |
| SUN Pharmaceutical Industries | Later holder | 2019 to now |
| Ranbaxy Signature | Acquired holder | 2020 to now |
| Nippon Shinyaku | Later holder |