Haloperidol
As of the edition of 20 October 2026, Haloperidol is a small molecule: marketed, first approved in 1960 (ES); acts on DRD2, DRD3 and DRD4 and 1 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Haldol
- First approved
- 1 February 1960 (ES)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- MOKSHA8 BRASIL INDUSTRIA E COMERCIO DE MEDICAMENTOS LTDA; 6 holders in all
- Registered trials
- 61, 10 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Cancer; Inherited and neonatal; Nutrition and metabolism
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 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Haloperidol.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 15 | 14 | 0 | 1 |
| Phase 1 | 6 | 3 | 1 | 0 |
| Phase 2 | 4 | 1 | 1 | 1 |
| Phase 3 | 14 | 6 | 3 | 4 |
| Phase 4 | 22 | 13 | 2 | 4 |
| All trials | 61 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Essential Pharma | Applicant | 1960 to now |
| Johnson & Johnson | Acquired holder and Lead sponsor of trials | 2003 to now |