Olmesartan medoxomil
As of the edition of 20 October 2026, Olmesartan medoxomil is a small molecule: marketed, first approved in 2002 (US); acts on AGTR1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Small molecule
- Brand name
- Benicar
- First approved
- 25 April 2002 (US)
- Approvals on record
- 16 in 2 regions
- Holder of the most recent approval
- Cosette Pharmaceuticals; 2 holders in all
- Registered trials
- 58, 5 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Hormones; Pregnancy and women's health; Urinary and reproductive
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 because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Olmesartan medoxomil.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| AGTR1 | Type-1 angiotensin II receptor | P30556 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 3 | 2 | 1 |
| Phase 1 | 8 | 7 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 26 | 23 | 0 | 3 |
| Phase 4 | 17 | 15 | 0 | 1 |
| All trials | 58 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Daiichi Sankyo | Originator and Lead sponsor of trials | 2000 to now |
| Cosette Pharmaceuticals | Acquired holder | 2022 to now |