Drugs / Sinemet
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SINEMET | — | 1975-05-02 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01533077 | Mar → Oct 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03007888 | Nov 2016 → Aug 2017 | Parkinson disease | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01171313 | Jul 2010 → Oct 2011 | Parkinson disease | XenoPort, Inc. | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT01070628 Comparator | Dec 2009 → Feb 2010 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02169453 Background | Oct 2008 → Jan 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1/2 | NCT05369533 Comparator | Aug 2022 → Mar 2024 | stroke disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT02116790 Comparator | May 2014 → Jan 2015 | — | Northwestern University | Withdrawn | No outcome recorded |
| Phase 2 | NCT01617135 Comparator | May → Nov 2012 | Parkinson disease | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02834507 Background | Mar → Nov 2005 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2004-05-17 | Impax Laboratories, LLC | IMPAX Receives Final FDA Approval for Generic Version of Sinemet CR; Sixth ANDA Approval in 2004 amneal.com ↗ |
| 2003-04-09 | Impax Laboratories, LLC | IMPAX Announces Merck's Withdrawal of Lawsuit Related to Generic Version of Sinemet CR amneal.com ↗ |
| 2003-02-24 | Impax Laboratories, LLC | IMPAX Comments on Merck's Lawsuit Related to Generic Version of Sinemet CR amneal.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sinemet | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02116790 ↗ |