Drugs / ADS-5102
ADS-5102
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT03567057 | Jul 2018 → Nov 2020 | multiple sclerosis | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02274766 | Oct 2014 → Mar 2016 | Parkinson disease, drug-induced dyskinesia, movement disorder | Adamas Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT02202551 | Jul 2014 → Feb 2018 | Parkinson disease, drug-induced dyskinesia, movement disorder | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02136914 | May 2014 → Dec 2015 | Parkinson disease, drug-induced dyskinesia, movement disorder | Adamas Pharmaceuticals, Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT01397422 Comparator | Jul 2011 → May 2013 | Parkinson disease, drug-induced dyskinesia, movement disorder | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-08-28 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Amantadine extended-release capsules 68.5 mg and tentative approval for 137 mg zyduslife.com ↗ |
| 2022-10-04 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Amantadine Extended-Release Capsules zyduslife.com ↗
Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Amantadine Extended-Release Capsules USP 68.5 mg and 137 mg (USRLD: Gocovri®). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-08-28 | Zydus Lifesciences Limited | Zydus receives final approval from USFDA for Amantadine extended-release capsules 68.5 mg and tentative approval for 137 mg zyduslife.com ↗ |
| 2022-10-04 | Zydus Lifesciences Limited | Zydus receives tentative approval from the USFDA for Amantadine Extended-Release Capsules zyduslife.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ADS-5102 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03567057 ↗ |
| Known as | amantadine | “This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16...” NCT03567057 ↗3“ADS-5102 (amantadine) extended-release (ER) capsules (GOCOVRITM) is a recent US FDA-approved treatment for dyskinesia in PD patients.” PMID 29532440 ↗ Apr 2018 “ADS-5102 (extended release amantadine HCl)” NCT01397422 ↗ “ADS-5102 (amantadine)” NCT02202551 ↗ |
| Known as | amantadine HCl | “ADS-5102 (extended release amantadine HCl)” NCT01397422 ↗ |
| Known as | Gocovri | “ADS-5102 (amantadine) extended-release (ER) capsules (GOCOVRITM) is a recent US FDA-approved treatment for dyskinesia in PD patients.” PMID 29532440 ↗ Apr 2018 |
| Known as | GOCOVRITM | “ADS-5102 (amantadine) extended-release (ER) capsules (GOCOVRITM) is a recent US FDA-approved treatment for dyskinesia in PD patients.” PMID 29532440 ↗ Apr 2018 |
| Route | Oral | “Oral capsules to be administered once daily at bedtime, for 8 weeks” NCT01397422 ↗ |