Azilsartan medoxomil
As of the edition of 20 October 2026, Azilsartan medoxomil is a small molecule: marketed, first approved in 2001 (JP); acts on AGTR1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Edarbi
- First approved
- 18 January 2001 (JP)
- Approvals on record
- 11 in 4 regions
- Holder of the most recent approval
- Bausch Health; 3 holders in all
- Withdrawn from market
- 27 October 2014 (in some regions)
- Registered trials
- 29, 2 stopped early
- Disease areas
- Heart and blood vessels; Hormones; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| AGTR1 | Type-1 angiotensin II receptor | P30556 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 0 |
| Phase 1 | 3 | 1 | 1 | 1 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 20 | 19 | 0 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Originator and Lead sponsor of trials | 2001 to now |
| Bausch Health | Acquired holder | 2012 to now |
| Azurity Pharmaceuticals | Acquired holder | 2022 to now |