Baclofen
As of the edition of 20 October 2026, Baclofen is a small molecule: marketed, first approved in 1970 (CH); acts on GABBR1 and GABBR2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1994
- Kind
- Small molecule
- Brand name
- Lioresal
- First approved
- 18 December 1970 (CH)
- Approvals on record
- 20 in 4 regions
- Holder of the most recent approval
- ROSEMOUNT PHARMACEUTICALS LLC; 9 holders in all
- Registered trials
- 68, 11 stopped early
- Disease areas
- Nervous system; Mental health; Chemically induced; Bones, joints and muscles; Digestive system; Injuries
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
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Baclofen.
See the 1 company-target row 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 | 14 | 7 | 3 | 2 |
| Phase 1 | 10 | 8 | 1 | 0 |
| Phase 2 | 14 | 8 | 1 | 4 |
| Phase 3 | 19 | 14 | 2 | 2 |
| Phase 4 | 11 | 6 | 0 | 3 |
| All trials | 68 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Medtronic | Later holder | 1992 to now |
| Novartis | Acquired holder | 2003 to now |
| UCB | Later holder and Lead sponsor of trials | 2003 to now |
| Amneal Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2007 to now |
| CNS Pharmaceuticals | Later holder | 2010 to now |
| Piramal Critical Care | Acquired holder and Lead sponsor of trials | 2012 to now |
| Metacel Pharmaceuticals | Later holder | 2019 to now |
| Azurity Pharmaceuticals | Later holder | 2022 to now |
| Strides Pharma | Acquired holder | 2026 to now |
| GEIGY Pharmaceuticals | Earlier holder |