Lisinopril anhydrous
As of the edition of 20 October 2026, Lisinopril anhydrous is a small molecule: marketed, first approved in 1987 (FR); acts on ACE.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1991
- Kind
- Small molecule
- Brand name
- Prinivil
- First approved
- 6 October 1987 (FR)
- Approvals on record
- 21 in 4 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 7 holders in all
- Registered trials
- 72, 11 stopped early
- Disease areas
- Heart and blood vessels; Hormones; Nutrition and metabolism; Urinary and reproductive; Pregnancy and women's health; 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 Lisinopril anhydrous.
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 |
|---|---|---|
| ACE | Angiotensin-converting enzyme | P12821 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 8 | 1 | 2 |
| Phase 1 | 23 | 21 | 1 | 0 |
| Phase 2 | 11 | 5 | 2 | 2 |
| Phase 3 | 12 | 8 | 0 | 4 |
| Phase 4 | 14 | 9 | 2 | 3 |
| All trials | 72 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 1987 to now |
| AstraZeneca | Later holder and Lead sponsor of trials | 1988 to now |
| Azurity Pharmaceuticals | Acquired holder | 2020 to now |
| Twi Pharmaceuticals | Acquired holder | 2023 to now |