Histamine
As of the edition of 20 October 2026, Histamine is a small molecule: marketed, first approved in 1982 (US); acts on HRH1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Ceplene
- First approved
- 1 January 1982 (US)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Japan Tobacco; 5 holders in all
- Registered trials
- 36, 3 stopped early
- Disease areas
- Skin and connective tissue; Cancer; Immune system; Ear, nose and throat; Lungs and airways; Blood and lymph
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.
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 Histamine.
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 |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 25 | 11 | 12 | 2 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 5 | 1 | 1 | 1 |
| Phase 3 | 2 | 1 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alk-Abello | Applicant | 1984 to now |
| Laboratoires Delbert | Applicant | 2008 to now |
| Japan Tobacco | Applicant | 2015 to now |
| Eli Lilly | Applicant |