Dexlansoprazole
As of the edition of 20 October 2026, Dexlansoprazole is a small molecule: marketed, first approved in 2009 (US); acts on ATP4A; no US protection is listed.
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
- Dexilant
- First approved
- 30 January 2009 (US)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Takeda; 2 holders in all
- Registered trials
- 48, 7 stopped early
- Disease areas
- Digestive system; Lungs and airways; Cancer; Blood and lymph; Ear, nose and throat; Immune system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ATP4A | Potassium-transporting ATPase alpha chain 1 | P20648 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 3 | 0 | 2 |
| Phase 1 | 13 | 11 | 0 | 1 |
| Phase 2 | 6 | 3 | 0 | 3 |
| Phase 3 | 14 | 13 | 0 | 1 |
| Phase 4 | 8 | 5 | 1 | 0 |
| All trials | 48 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Originator and Lead sponsor of trials | 2005 to now |