Rabeprazole
As of the edition of 20 October 2026, Rabeprazole is a small molecule: marketed, first approved in 1998 (FR); acts on ATP4A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Aciphex
- First approved
- 25 November 1998 (FR)
- Approvals on record
- 14 in 6 regions
- Holder of the most recent approval
- Eisai; 7 holders in all
- Registered trials
- 170, 5 stopped early
- Disease areas
- Digestive system; Cancer; Immune system; Infections; Lungs and airways; Blood and lymph
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 Rabeprazole.
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 |
|---|---|---|
| ATP4A | Potassium-transporting ATPase alpha chain 1 | P20648 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 25 | 16 | 0 | 2 |
| Phase 1 | 78 | 73 | 4 | 1 |
| Phase 2 | 10 | 9 | 1 | 0 |
| Phase 3 | 23 | 22 | 0 | 0 |
| Phase 4 | 34 | 20 | 1 | 2 |
| All trials | 170 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eisai | Applicant and Lead sponsor of trials | 1999 to now |
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2001 to now |
| Aytu BioPharma | Acquired holder | 2019 to now |
| Waylis Therapeutics | Acquired holder | 2024 to now |