Captopril

Overview

Captopril is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Captopril may be used in the treatment of hypertension.

Indication

For the treatment of essential or renovascular hypertension (usually administered with other drugs, particularly thiazide diuretics). May be used to treat congestive heart failure in combination with other drugs (e.g. cardiac glycosides, diuretics, β-adrenergic blockers). May improve survival in patients with left ventricular dysfunction following myocardial infarction. May be used to treat nephropathy, including diabetic nephropathy.

Associated Conditions

Aldosteronism
Anatomic renal artery stenosis
Congestive Heart Failure (CHF)
Diabetic Nephropathy
Heart Failure
Hypertension
Hypertensive crisis
Non-STEMI Acute Coronary Syndrome
Raynaud's Phenomenon
Ejection fraction of 40% or less Left ventricular dysfunction

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effect of Captopril on GLS in Duchenne Myodystrophy	2024/07/03	NCT06485661	Early Phase 1	Recruiting	Ain Shams University
A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril	2024/03/04	NCT06292091	Phase 1	Completed	Seoul National University Hospital
Alpha-lipoic Acid in Diabetic Nephropathy	2024/02/12	NCT06253429	Phase 3	Recruiting	Ain Shams University
NW Roselle in Grade 1 Essential Hypertension: Phase III Clinical Trial	2023/11/21	NCT06141200	Phase 3	Not yet recruiting	Natural Wellness Egypt
Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair	2023/09/15	NCT06039592	N/A	Recruiting	China National Center for Cardiovascular Diseases
Study of Drug Therapy for Pediatric Heart Failure	2023/09/15	NCT06039540	N/A	Recruiting	China National Center for Cardiovascular Diseases
Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation	2023/09/14	NCT06037434	N/A	Recruiting	China National Center for Cardiovascular Diseases
Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans	2022/07/05	NCT05442463	N/A	Recruiting	University of Calgary
Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma	2022/02/23	NCT05253495	Phase 2	Recruiting	New York Medical College
Bioequivalence Study Between Capoten Versus Captopril Reference Product in Healthy Adult Participants Under Fasting Conditions	2021/05/07	NCT04878315	Phase 1	Withdrawn	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Captopril	Solco Healthcare US, LLC	43547-364	ORAL	25 mg in 1 1	4/20/2023
Captopril	Hikma Pharmaceuticals USA Inc.	0143-1173	ORAL	50 mg in 1 1	8/14/2021
Captopril	DOH CENTRAL PHARMACY	53808-0359	ORAL	100 mg in 1 1	1/23/2017
Captopril	Legacy Pharmaceutical Packaging	68645-162	ORAL	50 mg in 1 1	4/11/2011
Captopril	Physicians Total Care, Inc.	54868-3724	ORAL	25 mg in 1 1	10/1/2012
Captopril	Major Pharmaceuticals	0904-7105	ORAL	12.5 mg in 1 1	6/15/2021
Captopril	AvKARE	73190-027	ORAL	25 mg in 1 1	4/22/2025
Captopril	Bryant Ranch Prepack	63629-8728	ORAL	25 mg in 1 1	12/16/2019
Captopril	Bryant Ranch Prepack	71335-2358	ORAL	50 mg in 1 1	11/23/2021
Captopril	Bryant Ranch Prepack	63629-8727	ORAL	12.5 mg in 1 1	12/16/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
CATOPLIN-25 TABLETS 25 mg	BEACONS PHARMACEUTICALS PTE. LTD.	SIN10401P	TABLET	25mg	11/11/1998
APO-CAPTO TABLET 12.5 mg	APOTEX INC	SIN06667P	TABLET	12.5 mg	11/14/1991
DEXACAP TABLET 25 mg	PT DEXA MEDICA	SIN08474P	TABLET	25 mg	12/13/1995
DEXACAP TABLET 12.5 mg	PT DEXA MEDICA	SIN08473P	TABLET	12.5 mg	12/13/1995
APO-CAPTO TABLET 50 mg	APOTEX INC	SIN06665P	TABLET	50 mg	11/14/1991
APO-CAPTO TABLET 25 mg	APOTEX INC	SIN06666P	TABLET	25 mg	11/14/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
EPSITRON 25 TAB 25MG	N/A	HEALTHCARE PHARMASCIENCE LIMITED	N/A	N/A	12/21/1998
CAPTOPRIL STADA 25 TAB 25MG	N/A	STADA PHARMACEUTICALS (ASIA) LIMITED	N/A	N/A	12/30/1997

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Capoten 25mg tablet blister pack	19247	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/30/1991
Capoten 50mg tablet blister pack	19248	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/30/1991
APO-CAPTOPRIL 50mg tablet blister pack	74008	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/8/2000
APO-CAPTOPRIL 12.5mg tablet blister pack	74001	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/8/2000
Capoten 12.5mg tablet blister pack	60608	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/28/1997
ZEDACE Captopril 25mg tablet blister pack	57370	Alphapharm Pty Ltd	Medicine	A	10/10/1996
ZEDACE Captopril 50mg tablet blister pack	57371	Alphapharm Pty Ltd	Medicine	A	10/10/1996
APO-CAPTOPRIL 25mg tablet blister pack	74004	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/8/2000
CAPOTEN captopril 5mg/mL oral liquid bottle	68962	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/23/1999

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MED CAPTOPRIL - TAB 25MG	medican pharma incorporated	02188937	Tablet - Oral	25 MG	8/22/1996
FTP-CAPTOPRIL	ftp-pharmacal inc.	02238451	Tablet - Oral	50 MG	10/9/1998
CAPTOPRIL	pharmel inc	02238557	Tablet - Oral	50 MG	9/3/1998
CAPTRIL	technilab pharma inc.	02237862	Tablet - Oral	25 MG	6/30/1998
CAPTOPRIL-25 TAB 25MG	PRO DOC LIMITEE	01910337	Tablet - Oral	25 MG	12/31/1991
NU-CAPTO TAB 50MG	nu-pharm inc	01913840	Tablet - Oral	50 MG	12/31/1991
TRIA-CAPTOPRIL 50MG TABLET	laboratoires trianon inc.	02229560	Tablet - Oral	50 MG	N/A
DOM-CAPTOPRIL	dominion pharmacal	02238551	Tablet - Oral	12.5 MG	9/17/1998
CAPTOPRIL	sorres pharma inc	02242789	Tablet - Oral	25 MG	10/26/2000
CAPTOPRIL	pharmel inc	02238556	Tablet - Oral	25 MG	9/3/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DILABAR DIU 50/25 mg COMPRIMIDOS	Dari Pharma S.L.	58510	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
CAPTOPRIL STADA 100 mg COMPRIMIDOS EFG	Laboratorio Stada S.L.	61574	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
CAPTOPRIL NORMON 25 mg COMPRIMIDOS EFG	Laboratorios Normon S.A.	61470	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
CAPTOPRIL CINFA 50 mg COMPRIMIDOS EFG	Laboratorios Cinfa S.A.	62305	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
CAPTOPRIL/HIDROCLOROTIAZIDA TEVA-RATIOPHARM 50/25 mg COMPRIMIDOS EFG	Teva Pharma S.L.U.	63526	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
CAPTOPRIL SANDOZ 25 MG COMPRIMIDOS EFG	Sandoz Farmaceutica S.A.	62424	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
CAPTOPRIL / HIDROCLOROTIAZIDA STADA 50 mg/25 mg COMPRIMIDOS EFG	Laboratorio Stada S.L.	62856	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
CAPTOPRIL / HIDROCLOROTIAZIDA NORMON 50 mg/25 mg COMPRIMIDOS EFG	Laboratorios Normon S.A.	63129	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
CAPTOPRIL MABO 50 mg COMPRIMIDOS EFG	Mabo Farma S.A.	64762	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized
CAPTOPRIL MYLAN 25 mg COMPRIMIDOS EFG	Mylan Pharmaceuticals S.L.	61619	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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