Phentolamine
As of the edition of 20 October 2026, Phentolamine is a small molecule: marketed, first approved in 1982 (US); acts on ADRA1A, ADRA1B and ADRA1D and 3 more; 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 1982
- Kind
- Small molecule
- Brand name
- Regitine
- First approved
- 1 January 1982 (US)
- Approvals on record
- 3 in 1 region
- Holder of the most recent approval
- Viatris; 3 holders in all
- Registered trials
- 30, 1 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Eye; Nutrition and metabolism; Lungs and airways; Chemically induced
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.
Viatris holds a later exclusivity on its own new formulation or combination product, which ended in 2026; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Phentolamine.
See the 3 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 | 6 | 4 | 1 | 0 |
| Phase 1 | 6 | 0 | 4 | 1 |
| Phase 2 | 7 | 7 | 0 | 0 |
| Phase 3 | 8 | 4 | 3 | 0 |
| Phase 4 | 3 | 2 | 1 | 0 |
| All trials | 30 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novalar Pharmaceuticals | Later holder and Lead sponsor of trials | 2003 to now |
| Ocuphire Pharma | Later holder and Lead sponsor of trials | 2007 to now |
| Septodont | Acquired holder | 2011 to now |
| Viatris | Acquired holder | 2024 to now |
| Novartis | Applicant |