Losartan
As of the edition of 20 October 2026, Losartan is a small molecule: marketed, first approved in 1994 (CH); acts on AGTR1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1995
- Kind
- Small molecule
- Brand name
- Cozaar
- First approved
- 21 December 1994 (CH)
- Approvals on record
- 15 in 5 regions
- Holder of the most recent approval
- Scienture; 8 holders in all
- Registered trials
- 256, 29 stopped early
- Disease areas
- Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism; Hormones; Cancer
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
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 Losartan.
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 | 50 | 25 | 5 | 3 |
| Phase 1 | 48 | 34 | 8 | 4 |
| Phase 2 | 49 | 21 | 12 | 8 |
| Phase 3 | 53 | 37 | 1 | 8 |
| Phase 4 | 56 | 35 | 6 | 6 |
| All trials | 256 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 1990 to now |
| Organon | Applicant, Acquired holder and Lead sponsor of trials | 1994 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2022 to now |
| Scienture | Later holder | 2025 to now |