Omeprazole
As of the edition of 20 October 2026, Omeprazole is a small molecule: marketed, first approved in 1987 (FR); acts on ATP4A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Prilosec
- First approved
- 15 April 1987 (FR)
- Approvals on record
- 30 in 5 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 12 holders in all
- Registered trials
- 314, 29 stopped early
- Disease areas
- Digestive system; Cancer; Immune system; Skin and connective tissue; Infections; Lungs and airways
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 Omeprazole.
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 |
|---|---|---|
| ATP4A | Potassium-transporting ATPase alpha chain 1 | P20648 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 30 | 20 | 3 | 4 |
| Phase 1 | 185 | 164 | 6 | 11 |
| Phase 2 | 23 | 15 | 3 | 5 |
| Phase 3 | 30 | 20 | 2 | 4 |
| Phase 4 | 46 | 30 | 3 | 5 |
| All trials | 314 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 1989 to now |
| Merck & Co. | Earlier holder | 1989 to now |
| Cheplapharm Arzneimittel | Applicant | 1989 to now |
| Dexcel Pharma Technologies | Later holder | 2007 to now |
| Azurity Pharmaceuticals | Acquired holder | 2026 to now |