Amphetamine
As of the edition of 20 October 2026, Amphetamine is a small molecule: marketed, first approved in 1982 (US); acts on SLC6A2 and SLC6A3; no US protection 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
- Biphetamine 12.5
- First approved
- 1 January 1982 (US)
- Approvals on record
- 37 in 1 region
- Holder of the most recent approval
- Tris Pharma; 6 holders in all
- Registered trials
- 39, 2 stopped early
- Disease areas
- Mental health; Chemically induced; Nervous system; Heart and blood vessels
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
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Amphetamine.
See the 2 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 | 8 | 6 | 1 | 0 |
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 4 | 3 | 0 | 0 |
| Phase 3 | 7 | 7 | 0 | 0 |
| Phase 4 | 16 | 10 | 3 | 2 |
| All trials | 39 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Arbor Pharmaceuticals | Later holder and Lead sponsor of trials | 2013 to now |
| Aytu BioPharma | Originator and Lead sponsor of trials | 2016 to now |
| Azurity Pharmaceuticals | Acquired holder | 2022 to now |