Doxepin
As of the edition of 20 October 2026, Doxepin is a small molecule: marketed, first approved in 1970 (ES); acts on HRH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1990
- Kind
- Small molecule
- Brand name
- Sinequan
- First approved
- 1 April 1970 (ES)
- Approvals on record
- 21 in 4 regions
- Holder of the most recent approval
- Currax Pharmaceuticals; 7 holders in all
- Registered trials
- 13, 3 stopped early
- Disease areas
- Mental health; Nervous system; Cancer; Mouth and teeth; Skin and connective tissue; Digestive 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 Doxepin.
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 | 2 | 1 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 4 | 2 | 0 | 1 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Medicis Pharmaceutical | Later holder | 1994 to now |
| New River Pharmaceuticals | Acquired holder | 2003 to now |
| Somaxon Pharmaceuticals | Later holder | 2010 to now |
| Viatris | Acquired holder | 2017 to now |
| Currax Pharmaceuticals | Acquired holder | 2019 to now |
| Fisons | Later holder | |
| Pfizer | Applicant |