Dalfampridine
As of the edition of 20 October 2026, Dalfampridine is a small molecule: marketed, first approved in 2010 (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 2012
- Kind
- Small molecule
- Brand name
- Ampyra
- First approved
- 22 January 2010 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Merz Pharma GmbH & Co. KGaA
- Registered trials
- 49, 7 stopped early
- Disease areas
- Nervous system; Immune system; Injuries; Eye; Cancer; Ear, nose and throat
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 | 9 | 5 | 1 | 2 |
| Phase 1 | 6 | 2 | 3 | 0 |
| Phase 2 | 15 | 9 | 2 | 4 |
| Phase 3 | 12 | 9 | 2 | 1 |
| Phase 4 | 7 | 7 | 0 | 0 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Acorda Therapeutics | Originator and Lead sponsor of trials | 2003 to now |
| Merz Pharma GmbH & Co. KGaA | Acquired holder | 2025 to now |