Irbesartan
As of the edition of 20 October 2026, Irbesartan is a small molecule: marketed, first approved in 1997 (CH); acts on AGTR1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Avalide
- First approved
- 15 August 1997 (CH)
- Approvals on record
- 25 in 7 regions
- Holder of the most recent approval
- Sanofi; 6 holders in all
- Withdrawn from market
- 17 April 2017 (in some regions)
- Registered trials
- 76, 4 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive; Hormones; Infections
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.
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 Irbesartan.
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 |
|---|---|---|
| AGTR1 | Type-1 angiotensin II receptor | P30556 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 7 | 2 | 2 |
| Phase 1 | 8 | 6 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 0 |
| Phase 3 | 23 | 19 | 0 | 2 |
| Phase 4 | 27 | 24 | 1 | 0 |
| All trials | 76 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant, Later holder and Lead sponsor of trials | 1997 to now |
| Zentiva k.s | Later holder | 2007 to now |
| Dainippon Sumitomo Pharma | Later holder | 2008 to now |
| Shionogi | Applicant | 2008 to now |