Gabapentin enacarbil
As of the edition of 20 October 2026, Gabapentin enacarbil is a small molecule: marketed, first approved in 2011 (US); acts on CACNA2D1; US protection ends in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Horizant
- First approved
- 6 April 2011 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Astellas; 2 holders in all
- Registered trials
- 29, 2 stopped early
- Disease areas
- Nervous system; Mental health; Hormones; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2026.
The last listed US drug-substance patent ends in 2026. The application that gives this date is held by Azurity Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Gabapentin enacarbil.
See the 2 companies 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 | 3 | 3 | 0 | 0 |
| Phase 1 | 5 | 4 | 0 | 1 |
| Phase 2 | 7 | 6 | 0 | 1 |
| Phase 3 | 6 | 6 | 0 | 0 |
| Phase 4 | 8 | 4 | 1 | 0 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Applicant and Lead sponsor of trials | 2007 to now |
| Azurity Pharmaceuticals | Acquired holder | 2022 to now |
| GSK | Originator | 2011 to 2022 |