Amantadine
As of the edition of 20 October 2026, Amantadine is a small molecule: marketed, first approved in 1967 (ES); acts on GRIN1, GRIN2A and GRIN2B and 4 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1987
- Kind
- Small molecule
- Brand name
- Symmetrel
- First approved
- 1 December 1967 (ES)
- Approvals on record
- 12 in 3 regions
- Holder of the most recent approval
- Supernus Pharmaceuticals; 5 holders in all
- Registered trials
- 66, 11 stopped early
- Disease areas
- Nervous system; Infections; Mental health; Lungs and airways; Injuries; Digestive system
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.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| GRIN2D | Glutamate receptor ionotropic, NMDA 2D | O15399 |
| GRIN3B | Glutamate receptor ionotropic, NMDA 3B | O60391 |
| GRIN1 | Glutamate receptor ionotropic, NMDA 1 | Q05586 |
| GRIN2A | Glutamate receptor ionotropic, NMDA 2A | Q12879 |
| GRIN2B | Glutamate receptor ionotropic, NMDA 2B | Q13224 |
| GRIN2C | Glutamate receptor ionotropic, NMDA 2C | Q14957 |
| GRIN3A | Glutamate receptor ionotropic, NMDA 3A | Q8TCU5 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 15 | 5 | 3 | 2 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 19 | 10 | 1 | 3 |
| Phase 3 | 20 | 12 | 1 | 4 |
| Phase 4 | 10 | 4 | 0 | 2 |
| All trials | 66 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Endo | Acquired holder | 2003 to now |
| Supernus Pharmaceuticals | Later holder and Lead sponsor of trials | 2009 to now |
| Osmotica Pharmaceutical | Later holder | 2018 to now |
| Dupont Merck | Earlier holder |