CARBIDOPA
Carbidopa tablets are indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.
Details
- Status
- Prescription
- First Approved
- 2014-03-10
- Routes
- ORAL
- Dosage Forms
- TABLET
CARBIDOPA Approval History
What CARBIDOPA Treats
7 FDA approvalsOriginally approved for its first indication in 2014 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Mar 2014)
- • Approved indication (Jan 2016)
- • Approved indication (Feb 2016)
- • Approved indication (Oct 2017)
- • Approved indication (May 2018)
- • Approved indication (Oct 2019)
- • Approved indication (Dec 2023)
Clinical Trial Registry
17 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 |
| 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 |
| 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 |
| 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.
CARBIDOPA FDA Label Details
Indications & Usage
Carbidopa tablets are indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Carbidopa tablets are for use with carbidopa-levodopa in patients for whom the dosage of carbidopa-levodopa provides less than adequate daily dosage (usually 70 mg daily) of carbidopa. Carbidopa tablets are for use with levodopa in the occasional patient whose ...
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CARBIDOPA AND LEVODOPA
Full clinical data, patents, trials, and competitive landscape for carbidopa.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.