Gabapentin
As of the edition of 20 October 2026, Gabapentin is a small molecule: marketed, first approved in 1993 (US); acts on CACNA2D1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Neurontin
- First approved
- 30 December 1993 (US)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- VIATRIS FARMACEUTICA DO BRASIL LTDA; 7 holders in all
- Registered trials
- 265, 43 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Chemically induced; Urinary and reproductive; Injuries
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
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 Gabapentin.
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 |
|---|---|---|
| CACNA2D1 | Voltage-dependent calcium channel subunit alpha-2/delta-1 | P54289 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 60 | 43 | 7 | 5 |
| Phase 1 | 22 | 19 | 0 | 2 |
| Phase 2 | 40 | 28 | 3 | 7 |
| Phase 3 | 71 | 43 | 6 | 15 |
| Phase 4 | 72 | 46 | 6 | 14 |
| All trials | 265 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 1993 to now |
| Abbott | Later holder | 2011 to now |
| Almatica Pharma | Acquired holder | 2020 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 2021 to now |