TheraRadar
Data updated: May 26, 2026

CARBIDOPA AND LEVODOPA (carbidopa)

CNS Approved 1992-08-28
Jump to: Indications Approvals Trials Competitors Safety Patents
24
Indications
--
Phase 3 Trials
33
Years on Market

Details

Status
Discontinued
First Approved
1992-08-28
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE, TABLET, CAPSULE, EXTENDED RELEASE, TABLET, ORALLY DISINTEGRATING

Companies

Apotex IMPAX LABS Sun Pharma ACCORD HLTHCARE Novartis BIOCON PHARMA LIMITED KV PHARM IDT AUSTRALIA LTD Teva ZYDUS PHARMS RUBICON RESEARCH Dr. Reddy's ALEMBIC WATSON LABS SCIEGEN PHARMS ASCENT PHARMS INC Aurobindo Pharma ANI PHARMS SCS Viatris RISING PHARMOBEDIENT
Active Ingredient: CARBIDOPA , LEVODOPA

CARBIDOPA AND LEVODOPA Approval History

1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
244 FDA actions from 1992 to 2026
May 2026 SUPPL
Label · Labeling
Mar 2025 SUPPL
Label · Labeling
Jan 2025 ORIGINAL
Update

What CARBIDOPA AND LEVODOPA Treats

24 FDA approvals

Originally approved for its first indication in 1992 . Covers 24 distinct patient populations.

  • Other (24)
📋

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

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 AND LEVODOPA FDA Label Details

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Data Sources

FDA Approval: ANDA076212 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.