Promethazine
As of the edition of 20 October 2026, Promethazine is a small molecule: marketed, first approved in 1952 (ES); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Phenergan
- First approved
- 1 July 1952 (ES)
- Approvals on record
- 18 in 4 regions
- Holder of the most recent approval
- OPELLA HEALTHCARE BRAZIL LTDA; 8 holders in all
- Registered trials
- 25, 3 stopped early
- Disease areas
- Nervous system; Digestive system; Mental health; Cancer; Skin and connective tissue; Chemically induced
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 Promethazine.
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 |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 1 |
| Phase 1 | 2 | 1 | 1 | 0 |
| Phase 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 6 | 3 | 0 | 1 |
| Phase 4 | 9 | 8 | 0 | 0 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| ANI Pharmaceuticals | Acquired holder | 2008 to now |
| Delcor Asset | Acquired holder | 2014 to now |
| Pharmobedient Consulting | Acquired holder | 2026 to now |
| Pfizer | Later holder |