Domperidone
As of the edition of 20 October 2026, Domperidone is a small molecule: marketed, first approved in 1979 (CH); acts on DRD2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Motilium
- First approved
- 30 May 1979 (CH)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- KENVUE LTDA.; 4 holders in all
- Registered trials
- 50, 12 stopped early
- Disease areas
- Digestive system; Nervous system; Pregnancy and women's health; Urinary and reproductive; Heart and blood vessels; Immune system
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 Domperidone.
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 |
|---|---|---|
| DRD2 | Dopamine receptor D2 | P14416 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 21 | 6 | 2 | 3 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 12 | 7 | 0 | 5 |
| Phase 3 | 8 | 2 | 2 | 3 |
| Phase 4 | 6 | 4 | 0 | 1 |
| All trials | 50 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Aché Laboratórios Farmacêuticos | Applicant | 2019 to now |