Valsartan
As of the edition of 20 October 2026, Valsartan is a small molecule: marketed, first approved in 1996 (BR); acts on AGTR1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2007
- Kind
- Small molecule
- Brand name
- Diovan
- First approved
- 29 November 1996 (BR)
- Approvals on record
- 57 in 7 regions
- Holder of the most recent approval
- Novartis; 7 holders in all
- Withdrawn from market
- 3 April 2017 (in some regions)
- Registered trials
- 320, 27 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Urinary and reproductive; Pregnancy and women's health; Hormones; Nervous system
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 Valsartan.
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 | 50 | 26 | 3 | 4 |
| Phase 1 | 29 | 17 | 3 | 0 |
| Phase 2 | 27 | 18 | 5 | 2 |
| Phase 3 | 92 | 70 | 7 | 10 |
| Phase 4 | 122 | 83 | 6 | 11 |
| All trials | 320 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 1996 to now |
| Ajinomoto | Applicant | 2014 to now |
| Carmel Biosciences | Later holder | 2017 to now |