Metoclopramide
As of the edition of 20 October 2026, Metoclopramide is a small molecule: marketed, first approved in 1964 (ES); acts on DRD2.
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
- Reglan
- First approved
- 1 December 1964 (ES)
- Approvals on record
- 14 in 5 regions
- Holder of the most recent approval
- Baxter Healthcare; 10 holders in all
- Registered trials
- 81, 14 stopped early
- Disease areas
- Nervous system; Digestive system; Urinary and reproductive; Cancer; Pregnancy and women's health; 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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Metoclopramide.
See the 3 companies 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 | 12 | 2 | 5 |
| Phase 1 | 2 | 1 | 1 | 0 |
| Phase 2 | 12 | 8 | 1 | 2 |
| Phase 3 | 20 | 12 | 0 | 5 |
| Phase 4 | 26 | 16 | 5 | 2 |
| All trials | 81 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Later holder | 1983 to now |
| UCB | Later holder and Lead sponsor of trials | 2005 to now |
| Bausch Health | Later holder | 2009 to now |
| ANI Pharmaceuticals | Acquired holder | 2011 to now |
| Viatris | Acquired holder | 2011 to now |
| QOL Medical | Later holder and Lead sponsor of trials | 2014 to now |
| Hikma Pharmaceuticals | Acquired holder | 2021 to now |
| Baxter Healthcare | Applicant | 2022 to now |