Carbidopa

Overview

Carbidopa presents a chemical denomination of N-amino-alpha-methyl-3-hydroxy-L-tyrosine monohydrate. It potently inhibits aromatic amino acid decarboxylase (DDC) and due to its chemical properties, it does not cross the blood-brain barrier. Due to its activity, carbidopa is always administered concomitantly with levodopa. An individual formulation containing solely carbidopa was generated to treat nausea in patients where the combination therapy levodopa/carbidopa is not efficient reducing nausea. The first approved product by the FDA containing only carbidopa was developed by Amerigens Pharmaceuticals Ltd and approved on 2014. On the other hand, the combination treatment of carbidopa/levodopa was originally developed by Watson Labs but the historical information by the FDA brings back to the approval of this combination therapy developed by Mayne Pharma in 1992.

Indication

Carbidopa is indicated with levodopa for the treatment of symptoms of idiopathic Parkinson disease, postencephalitic parkinsonism and symptomatic parkinsonism followed by carbon monoxide or manganese intoxication. The combination therapy is administered for the reduction of levodopa-driven nausea and vomiting. The product of carbidopa should be used in patients where the combination therapy of carbidopa/levodopa provide less than the adequate daily dosage. As well carbidopa can be used in patients where the dosages of carbidopa and levodopa require individual titration.

Associated Conditions

Parkinson's Disease (PD)
Parkinsonism post encephalitic
Symptomatic Parkinson Disease
Levodopa-driven nausea and vomiting

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Supplemental Open-Label Arm	2024/09/19	NCT06587217	Phase 1	Completed	University of Michigan
Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease	2024/05/29	NCT06432309	Not Applicable	Completed	University Hospital of Ferrara
Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease	2024/02/01	NCT06236230	Phase 4	Recruiting	Second Affiliated Hospital of Soochow University
Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Placebo-Controlled Arm	2024/01/23	NCT06219915	Phase 1	Completed	University of Michigan
A TQT Study to Evaluate the Electrocardiographic Effects of Carbidopa in Healthy Subjects	2023/12/07	NCT06161220	Phase 1	Completed	Impax Laboratories, LLC
Dopaminergic Therapy for Anhedonia - 2	2023/10/10	NCT06075771	Phase 4	Recruiting	Emory University
Personalized Real-Time DBS and PD Mechanisms	2023/08/28	NCT06013956	Phase 4	Recruiting	David Escobar
Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke	2022/05/11	NCT05369533	Phase 1	Completed	University of California, Los Angeles
Treating Early Stage Diabetic Retinopathy	2021/11/24	NCT05132660	Early Phase 1	ENROLLING_BY_INVITATION	VA Office of Research and Development
Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease	2021/07/07	NCT04952194	Phase 4	Recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Carbidopa and levodopa	Aphena Pharma Solutions - Tennessee, LLC	71610-579	ORAL	25 mg in 1 1	8/5/2021
Carbidopa and levodopa	Major Pharmaceuticals	0904-7257	ORAL	25 mg in 1 1	5/17/2022
CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	16571-691	ORAL	25 mg in 1 1	2/1/2022
Carbidopa and levodopa	Actavis Pharma, Inc.	0228-2540	ORAL	25 mg in 1 1	9/1/2020
Stalevo	Almatica Pharma LLC	52427-842	ORAL	50 mg in 1 1	12/31/2019
Carbidopa, levodopa and entacapone	Sun Pharmaceutical Industries, Inc.	47335-001	ORAL	12.5 mg in 1 1	3/1/2019
Carbidopa, levodopa and entacapone	Sun Pharmaceutical Industries, Inc.	47335-005	ORAL	37.5 mg in 1 1	3/1/2019
Carbidopa and Levodopa	Physicians Total Care, Inc.	54868-2866	ORAL	10 mg in 1 1	2/2/2012
Carbidopa, Levodopa, and Entacapone	Sandoz Inc	0781-5637	ORAL	25 mg in 1 1	2/1/2016
Stalevo	Almatica Pharma LLC	52427-827	ORAL	31.25 mg in 1 1	12/31/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)	Orion Corporation,Orionintie 1,02 200 Espoo,Finland	Authorised	11/11/2013
Stalevo	Orion Corporation,Orionintie 1,FI-02200 Espoo,Finland	Authorised	10/17/2003
Levodopa/Carbidopa/Entacapone Orion	Orion Corporation,Orionintie 1,FI-02200 Espoo,Finland	Authorised	8/23/2011

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TIDOMET FORTE TABLET	TORRENT PHARMACEUTICALS LTD	SIN12575P	TABLET	25 mg	7/31/2004
CREDANIL 25/250 TABLET	REMEDICA LTD	SIN10286P	TABLET	25 mg	10/14/1998
Stalevo Film Coated Tablets 100/25/200 mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN13142P	TABLET, FILM COATED	25 mg	8/29/2005
Stalevo Film Coated Tablets 50/12.5/200 mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN13143P	TABLET, FILM COATED	12.5 mg	8/29/2005
CREDANIL 25/100 TABLET	REMEDICA LTD	SIN10285P	TABLET	25 mg	10/14/1998
ANTIPAR FILM COATED TABLET 100 mg/25 mg/200 mg	İlko İlaç Sanayi ve Ticaret A. Ş.	SIN16956P	TABLET, FILM COATED	25mg	2/20/2024
ANTIPAR FILM COATED TABLET 150 mg/37.5 mg/200 mg	İlko İlaç Sanayi ve Ticaret A. Ş.	SIN16957P	TABLET, FILM COATED	37.5mg	2/20/2024
Stalevo Film Coated Tablet 200/50/200mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN13566P	TABLET, FILM COATED	50mg	11/3/2008
SINEMET CR 50/200 TABLET	MERCK SHARP & DOHME (AUSTRALIA) PTY LTD, Savio Industrial S.r.L	SIN07202P	TABLET	50 mg	10/12/1992
Stalevo Film Coated Tablets 150/37.5/200 mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN13141P	TABLET, FILM COATED	37.5 mg	8/29/2005

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Carbidopa Tablets	精华制药集团股份有限公司	国药准字H10970017	化学药品	片剂	6/2/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
LECTEVA levodopa/carbidopa/entacapone 200 mg/50 mg/200 mg tablet bottle	238866	Teva Pharma Australia Pty Ltd	Medicine	A	4/7/2016
CARLEVENT levodopa/carbidopa/entacapone 150/37.5/200 mg tablet bottle	195749	Medis Pharma Pty Ltd	Medicine	A	10/3/2013
LECTEVA levodopa/carbidopa/entacapone 75 mg/18.75 mg/200 mg tablet bottle	238861	Teva Pharma Australia Pty Ltd	Medicine	A	4/7/2016
Carbidopa and Levodopa Tablets, USP, 25mg/ 100mg	303437	Mayne Pharma International Pty Ltd	Medicine	A	5/25/2018
LEVODOPA/CARBIDOPA GenPar 100/25 levodopa 100 mg and carbidopa (as monohydrate) 25 mg tablet blister pack	275987	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/11/2018
LEVODOPA/CARBIDOPA GxP 100/25 levodopa 100 mg and carbidopa (as monohydrate) 25 mg tablet blister pack	275976	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/11/2018
LEVODOPA/CARBIDOPA-WGR 100/25 levodopa 100 mg / carbidopa (as monohydrate) 25 mg tablet bottle	275978	GM Pharma International Pty Ltd	Medicine	A	1/11/2018
SINADOPA 250/25 levodopa 250 mg and carbidopa (as monohydrate) 25 mg tablet bottle	275966	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/11/2018
Levodopa 250 mg with Carbidopa 25 mg tablet bottle	387019	Alphapharm Pty Ltd	Medicine	A	4/12/2022
L.C.E. SANDOZ 150/37.5/200 levodopa 150 mg, carbidopa (as carbidopa monohydrate) 37.5 mg and entacapone 200 mg film-coated tablet bottle	192176	Sandoz Pty Ltd	Medicine	A	11/14/2013

Related News

Indian-Origin Scientists Develop Weekly Injectable for Parkinson's Disease Treatment

2 months ago

Scientists at the University of South Australia, led by Indian-origin researchers, have developed a once-weekly injectable formulation that delivers levodopa and carbidopa for Parkinson's disease treatment.

Amneal's CREXONT Shows Significant Sleep Quality Improvements in Parkinson's Disease Patients

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New Phase 3 RISE-PD study data reveals CREXONT (carbidopa/levodopa extended-release) significantly improved sleep quality in Parkinson's disease patients compared to immediate-release formulations, with a mean difference of -2.35 in PDSS-2 scores (p<0.0001).

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