SINEMET (carbidopa)
SINEMET is indicated for the treatment of Parkinson's Disease; Post-Encephalitic Parkinsonism; Parkinsonism; Carbon Monoxide Intoxication; Manganese Intoxication; Nausea; Vomiting.
How SINEMET Works
Parkinson's disease symptoms are characterized by the depletion of dopamine in the corpus striatum. Because exogenous dopamine cannot cross the blood-brain barrier, it is ineffective as a direct treatment. Levodopa, the metabolic precursor of dopamine, is able to cross the blood-brain barrier, where it is converted into dopamine to alleviate motor symptoms. Carbidopa functions as an aromatic amino acid decarboxylase inhibitor, specifically blocking the peripheral conversion of levodopa to dopamine before it reaches the central nervous system. This mechanism increases the bioavailability of levodopa for the brain without carbidopa exerting a primary effect on the nervous system itself.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1975-05-02
- Routes
- ORAL
- Dosage Forms
- TABLET
SINEMET Approval History
What SINEMET Treats
7 indicationsSINEMET is approved for 7 conditions since its original approval in 1975. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinson's Disease
- Post-Encephalitic Parkinsonism
- Parkinsonism
- Carbon Monoxide Intoxication
- Manganese Intoxication
- Nausea
- Vomiting
SINEMET Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SINEMET
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04520178 5-HTP only | Pro00119483/00125176 | Ph 2, Ph 3 | recruiting | Effects of 5HTP on the Injured Human Spinal Cord |
| NCT04325503 RES results posted | HUM00156490 5U01AG061393-05 | Ph 1, Ph 2 | completed | Neurobiological Drivers of Mobility Resilience: The Dopaminergic System |
| NCT01323374 FMS201 | Droxidopa FMS201 | Ph 2 | completed | Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia |
| NCT04000919 | 18.1268 | Ph 2, Ph 3 | suspended | Effects of 5HTP and LDOPA on CNS Excitability After SCI |
| NCT03007888 results posted | IPX203-B16-01 | Ph 2 | completed | A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease |
| NCT00685919 results posted | 101499 HL071784-05A1 | Ph 2, Ph 3 | completed | Peripheral Dopamine in Postural Tachycardia Syndrome |
| NCT03055936 COMDOS1 results posted | 3112005 | Ph 1 | completed | Dose-finding Pharmacokinetic Study in Healthy Males |
| NCT03266965 | 20161186 W81XWH-16-1-0462 | Ph 1 | completed | Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach |
| NCT03115827 results posted | VUMC54580 | Ph 4 | completed | Norepinephrine-targeted Therapy for Action Control in Parkinson Disease |
| NCT01399905 results posted | IRB00004133 | Ph 2 | completed | High and Low Dose Carbidopa Treatment of Parkinson's Disease |
| NCT03887884 | CVT-301-012 | Ph 1 | completed | Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) |
| NCT00845000 results posted | P05550 MK-3814-023 | Ph 1 | completed | Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) |
| NCT02633839 | CVT-301-007 | Ph 1 | completed | A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults |
| NCT02633007 | CVT-301-008 | Ph 1 | completed | A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma |
| NCT01212484 results posted | 09-0011 | Ph 3 | completed | Carbidopa for the Treatment of Nausea and Vomiting in Familial Dysautonomia |
| NCT01227655 BIPARKII results posted | BIA-91067-302 2010-022366-27, BIA-91067-302 | Ph 3 | completed | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients. |
| NCT01568073 results posted | BIA-91067-301 2010-021860-13 | Ph 3 | completed | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon |
| NCT02116790 | STU00083465 R01DE022746 | Ph 2 | withdrawn | Efficacy of Co-administration of an NSAID With a Dopamine Agonist In Healthy Subjects |
| NCT01229332 | ND0611/002 | Ph 1, Ph 2 | completed | A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients |
| NCT01296464 PARTEST | 2939136 | Ph 2 | completed | Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SINEMET FDA Label Details
Indications & Usage
FDA Label (PDF)SINEMET is indicated for the treatment of Parkinson's Disease; Post-Encephalitic Parkinsonism; Parkinsonism; Carbon Monoxide Intoxication; Manganese Intoxication; Nausea; Vomiting.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment