Cocaine
As of the edition of 20 October 2026, Cocaine is a small molecule: marketed, first approved in 2017 (US); acts on SCN10A, SCN11A and SCN1A and 7 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Goprelto
- First approved
- 14 December 2017 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Omnivium Pharmaceuticals; 2 holders in all
- Registered trials
- 42, 5 stopped early
- Disease areas
- Chemically induced; Mental health; Heart and blood vessels; Injuries; Nutrition and metabolism
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.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| SCN1A | Sodium channel protein type 1 subunit alpha | P35498 |
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
| SCN7A | Sodium channel protein type 7 subunit alpha | Q01118 |
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
| SCN9A | Sodium channel protein type 9 subunit alpha | Q15858 |
| SCN2A | Sodium channel protein type 2 subunit alpha | Q99250 |
| SCN3A | Sodium channel protein type 3 subunit alpha | Q9NY46 |
| SCN11A | Sodium channel protein type 11 subunit alpha | Q9UI33 |
| SCN8A | Sodium channel protein type 8 subunit alpha | Q9UQD0 |
| SCN10A | Sodium channel protein type 10 subunit alpha | Q9Y5Y9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 29 | 24 | 1 | 3 |
| Phase 2 | 7 | 6 | 0 | 1 |
| Phase 3 | 2 | 1 | 1 | 0 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 42 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lannett | Later holder and Lead sponsor of trials | 2015 to now |
| Omnivium Pharmaceuticals | Acquired holder | 2023 to now |
| Lxo Ireland Designated Activity | Acquired holder | 2026 to now |
| Genus Life Sciences | Originator | 2017 to 2026 |