Pregabalin
As of the edition of 20 October 2026, Pregabalin is a small molecule: marketed, first approved in 2004 (EU); acts on CACNA2D1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Lyrica
- First approved
- 5 July 2004 (EU)
- Approvals on record
- 28 in 5 regions
- Holder of the most recent approval
- VIATRIS FARMACEUTICA DO BRASIL LTDA; 12 holders in all
- Withdrawn from market
- 4 October 2023 (in some regions)
- Registered trials
- 335, 42 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Mental health; Hormones; Cancer; Chemically induced
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
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 Pregabalin.
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 | 63 | 24 | 19 | 5 |
| Phase 1 | 37 | 32 | 3 | 0 |
| Phase 2 | 42 | 21 | 3 | 8 |
| Phase 3 | 106 | 84 | 1 | 11 |
| Phase 4 | 87 | 55 | 3 | 18 |
| All trials | 335 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Later holder and Lead sponsor of trials | 1997 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 2004 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2014 to now |
| Adium | Later holder | 2014 to now |
| Apsen Farmaceutica | Later holder | 2020 to now |
| Libbs Farmacêutica LTDA | Later holder | 2023 to now |