Glatiramer acetate
As of the edition of 20 October 2026, Glatiramer acetate is a small molecule: marketed, first approved in 1996 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Copaxone
- First approved
- 20 December 1996 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Takeda; 2 holders in all
- Registered trials
- 46, 9 stopped early
- Disease areas
- Nervous system; Immune system; Eye; Inherited and neonatal; Nutrition and metabolism; Bones, joints and muscles
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 7 | 1 | 1 |
| Phase 1 | 3 | 0 | 0 | 0 |
| Phase 2 | 11 | 7 | 0 | 3 |
| Phase 3 | 12 | 9 | 0 | 2 |
| Phase 4 | 9 | 5 | 0 | 3 |
| All trials | 46 |