Gocovri
(amantadine sulfate)Phase 2Small molecule
Endo Pharmaceuticals1
Indications
6
Total Trials
1
Active Trials
0
Competitors
9
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Indication
Clinical
Trials by Indication[1]
Disorders of Consciousness1 trial
Hemodynamic Response1 trial
Oral Amantadine, IV Amantadine and Hemodynamic Response to Laryngoscopy
Unknown status·—·Phase 2·NCT03612921·60 enrolled
Amantadine1 trial
Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients
Completed·—·Phase 2/3·NCT03178708·60 enrolled
Brain Injury1 trial
Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU
Completed·—·Phase 3·NCT06052787·150 enrolled
1 more indication
Cognitive Functions1 trial
Regulatory
FDA Approval Timeline[4]
Jan 1, 1982
SYMMETREL
NDA NDA016023
Jan 1, 1982
SYMMETREL
NDA NDA016020
Jan 1, 1982
SYMMETREL
NDA NDA018101
Aug 24, 2017
GOCOVRI
NDA NDA208944
Aug 24, 2017
GOCOVRI
NDA NDA208944
Feb 16, 2018
OSMOLEX ER
NDA NDA209410
Mar 10, 2020
GOCOVRI
NDA NDA208944
Feb 1, 2021
GOCOVRI
NDA NDA208944
Jul 10, 2025
GOCOVRI
NDA NDA208944
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for amantadine sulfate. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[2]
- Highest Phase
- Phase 2[1]
- Company