Telmisartan
As of the edition of 20 October 2026, Telmisartan is a small molecule: marketed, first approved in 1998 (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 2018
- Kind
- Small molecule
- Brand name
- Micardis
- First approved
- 10 November 1998 (US)
- Approvals on record
- 38 in 7 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 5 holders in all
- Withdrawn from market
- 17 February 2014 (in some regions)
- Registered trials
- 230, 20 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Hormones; Urinary and reproductive; Pregnancy and women's health; Lungs and airways
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 Telmisartan.
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 | 53 | 44 | 2 | 5 |
| Phase 1 | 53 | 47 | 3 | 1 |
| Phase 2 | 20 | 14 | 2 | 4 |
| Phase 3 | 57 | 47 | 2 | 5 |
| Phase 4 | 47 | 36 | 1 | 5 |
| All trials | 230 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Originator and Lead sponsor of trials | 1997 to now |
| Bayer | Applicant and Lead sponsor of trials | 1998 to now |