Esomeprazole
As of the edition of 20 October 2026, Esomeprazole is a small molecule: marketed, first approved in 2000 (FR); acts on ATP4A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Nexium
- First approved
- 12 September 2000 (FR)
- Approvals on record
- 30 in 8 regions
- Holder of the most recent approval
- COSMED INDUSTRIA DE COSMETICOS E MEDICAMENTOS S.A.; 10 holders in all
- Registered trials
- 292, 19 stopped early
- Disease areas
- Digestive system; Cancer; Bones, joints and muscles; Immune system; Lungs and airways; Skin and connective tissue
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 Esomeprazole.
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 | 45 | 25 | 5 | 6 |
| Phase 1 | 64 | 58 | 1 | 0 |
| Phase 2 | 16 | 9 | 2 | 2 |
| Phase 3 | 63 | 52 | 1 | 4 |
| Phase 4 | 104 | 73 | 5 | 7 |
| All trials | 292 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Grünenthal | Applicant | 2000 to now |
| AstraZeneca | Applicant and Lead sponsor of trials | 2000 to now |
| Hanmi Pharmaceutical | Later holder and Lead sponsor of trials | 2013 to now |
| Haleon | Applicant and Lead sponsor of trials | 2013 to now |
| Dexcel Pharma Technologies | Later holder | 2020 to now |
| Belcher Pharmatech | Acquired holder | 2020 to now |