Dihydroergotamine
As of the edition of 20 October 2026, Dihydroergotamine is a small molecule: marketed, first approved in 1946 (CA); acts on HTR1D; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- D.H.E. 45
- First approved
- 31 December 1946 (CA)
- Approvals on record
- 9 in 3 regions
- Holder of the most recent approval
- Amneal Pharmaceuticals; 7 holders in all
- Registered trials
- 14, 0 stopped early
- Disease areas
- Nervous system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Shin Nippon Biomedical holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
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 Dihydroergotamine.
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 |
|---|---|---|
| HTR1D | 5-hydroxytryptamine receptor 1D | P28221 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 5 | 4 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sterimax | Applicant | 1946 to now |
| Shin Nippon Biomedical | Later holder and Lead sponsor of trials | 2018 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Impel Pharmaceuticals | Acquired holder | 2024 to now |
| Amneal Pharmaceuticals | Later holder | 2025 to now |
| Novartis | Applicant |