Treats Parkinson's disease. Sold as Stalevo 50, Stalevo 100, Stalevo 150, Stalevo 200, Stalevo 75 and 1 more. Every FDA application for this active ingredient: 1 branded and 7 generic.
As of Nov 15, 2026, FDA lists 8 applications for Carbidopa; Entacapone; Levodopa (sold as Stalevo 50, Stalevo 100, Stalevo 150 and others), first approved Jun 11, 2003, with 0 new uses approved and 0 published complete response letters.
| Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's DiseasePARKINSON DISEASE (Disorder) · University Hospital Tuebingen | Phase 3 | Recruiting | Sep 3, 2025 |
| Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's DiseaseAdvanced Parkinson Disease · Britannia Pharmaceuticals Ltd. | — | Active, not recruiting | Sep 14, 2021 |
| Gait Analysis in Neurological DiseaseParkinson's Disease, Parkinsonian Disorders · Beth Israel Deaconess Medical Center | — | Active, not recruiting | Dec 16, 2016 |
| Jun 11, 2003 | Stalevo 50, Stalevo 100NDA 21485 · New combination | Orion Pharma | 18 | Marketed |
| May 10, 2012 | Carbidopa, Levodopa And EntacaponeANDA 79085 | Sun Pharm | 1 | Discontinued |
| Nov 20, 2012 | Carbidopa, Levodopa And EntacaponeANDA 90786 | Wockhardt Ltd | 1 | Discontinued |
| Nov 20, 2012 | Carbidopa, Levodopa And EntacaponeANDA 90833 | Wockhardt Ltd | 1 | Discontinued |
| Aug 13, 2020 | Carbidopa, Levodopa And EntacaponeANDA 203424 | Pharmobedient | 0 | Discontinued |
| Jan 25, 2022 | Carbidopa, Levodopa And EntacaponeANDA 213212 | Rising | 1 | Marketed |
| Apr 15, 2025 | Carbidopa, Levodopa And EntacaponeANDA 214495 | Macleods Pharms | 1 | Marketed |
| Feb 5, 2026 | Carbidopa, Levodopa And EntacaponeANDA 218535 | Alembic | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Alembic