Trandolapril

Overview

Trandolapril is a non-sulhydryl prodrug that belongs to the angiotensin-converting enzyme (ACE) inhibitor class of medications. It is metabolized to its biologically active diacid form, trandolaprilat, in the liver. Trandolaprilat inhibits 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). Trandolapril may be used to treat mild to moderate hypertension, to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction, as an adjunct treatment for congestive heart failure, and to slow the rate of progression of renal disease in hypertensive individuals with diabetes mellitus and microalbuminuria or overt nephropathy.

Indication

用于高血压、心力衰竭以及延迟和逆转高血压所引起的心脏病理变化。

Associated Conditions

Heart Failure
Hypertension
Left Ventricular Dysfunction

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fed Conditions	2010/07/19	NCT01164800	Phase 1	Completed	Dr. Reddy's Laboratories Limited
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions	2010/07/19	NCT01164787	Phase 1	Completed	Dr. Reddy's Laboratories Limited
Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)	2009/04/24	NCT00887510	Phase 4	Completed	University of Florida
Trandolapril 4 mg Tablet Under Fasting Conditions	2009/02/10	NCT00840632	Phase 1	Completed	Teva Pharmaceuticals USA
Trandolapril 4 mg Tablet Under Non-Fasting Conditions	2009/02/10	NCT00840073	Phase 1	Completed	Teva Pharmaceuticals USA
Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone	2006/10/25	NCT00391846	Phase 4	Completed	AstraZeneca
A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT)	2005/10/10	NCT00235014	Phase 4	Completed	Abbott
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)	2005/10/06	NCT00233532	Phase 4	Completed	Abbott

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Trandolapril	A-S Medication Solutions	50090-4120	ORAL	2 mg in 1 1	11/2/2018
Trandolapril and Verapamil Hydrochloride	Glenmark Pharmaceuticals Inc., USA	68462-295	ORAL	2 mg in 1 1	9/30/2019
Trandolapril	Epic Pharma, LLC	42806-054	ORAL	4 mg in 1 1	7/26/2018
Trandolapril	Rising Health, LLC	57237-090	ORAL	2 mg in 1 1	9/21/2019
Trandolapril	A-S Medication Solutions	50090-4128	ORAL	1 mg in 1 1	12/5/2019
Trandolapril	Rising Health, LLC	57237-091	ORAL	4 mg in 1 1	9/21/2019
Trandolapril	Bryant Ranch Prepack	63629-8003	ORAL	2 mg in 1 1	12/9/2021
Trandolapril	Lupin Pharmaceuticals, Inc.	68180-568	ORAL	4 mg in 1 1	8/1/2025
Trandolapril	Aurobindo Pharma Limited	65862-164	ORAL	1 mg in 1 1	7/4/2022
Mavik	Physicians Total Care, Inc.	54868-5099	ORAL	4 mg in 1 1	2/14/2012

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
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
GENRX TRANDOLAPRIL trandolapril 4 mg capsules blister pack	135987	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/13/2008
TRANDOLAPRIL- LUPIN CAPSULES trandolapril 2 mg capsules blister pack	135976	Lupin Australia Pty Limited	Medicine	A	6/13/2008
TRANDOLAPRIL-DWRN trandolapril 2 mg capsule blister pack	423110	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/3/2024
TRANDOLAPRIL-RJIC trandolapril 2 mg capsule blister pack	423051	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/3/2024
TARKA 2/180 trandolapril 2mg & verapamil hydrochloride 180mg tablet	104663	Viatris Pty Ltd	Medicine	A	10/24/2005
GENRX TRANDOLAPRIL trandolapril 0.5 mg capsules blister pack	135964	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/13/2008
TRANDOLAPRIL- LUPIN CAPSULES trandolapril 0.5 mg capsules blister pack	135859	Lupin Australia Pty Limited	Medicine	A	6/13/2008
TARKA 4/240 trandolapril 4mg & verapamil hydrochloride 240mg tablet	104664	Viatris Pty Ltd	Medicine	A	10/24/2005
GOPTEN trandolapril 1 mg capsule blister pack	45455	Viatris Pty Ltd	Medicine	A	1/24/1994
TRANALPHA trandolapril 0.5 mg capsules blister pack	198992	Alphapharm Pty Ltd	Medicine	A	8/28/2012

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AURO-TRANDOLAPRIL	auro pharma inc	02471868	Capsule - Oral	0.5 MG	9/27/2018
TEVA-TRANDOLAPRIL	teva canada limited	02415445	Capsule - Oral	2 MG	9/26/2018
TRANDOLAPRIL	sanis health inc	02525070	Capsule - Oral	4 MG	11/19/2022
PMS-TRANDOLAPRIL	Pharmascience Inc	02357771	Capsule - Oral	2 MG	5/18/2018
APO-TRANDOLAPRIL	Apotex Inc	02487187	Capsule - Oral	0.5 MG	N/A
SANDOZ TRANDOLAPRIL	Sandoz Canada, Inc.	02325721	Capsule - Oral	0.5 MG	7/12/2018
TRANDOLAPRIL	sanis health inc	02525054	Capsule - Oral	2 MG	11/10/2022
TRANDOLAPRIL	PRO DOC LIMITEE	02488698	Capsule - Oral	1 MG	7/9/2019
TRANDOLAPRIL	sanis health inc	02525038	Capsule - Oral	0.5 MG	N/A
TARKA	ABBOTT LABORATORIES, LIMITED	02240945	Tablet (Extended-Release) - Oral	1 MG	7/15/2002

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TARKA 180 mg/ 2 mg CAPSULAS DE LIBERACION MODIFICADA	Viatris Healthcare Limited	61369	CÁPSULA DURA DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica	Commercialized
GOPTEN 0,5 mg CAPSULAS DURAS	Viatris Healthcare Limited	59984	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
GOPTEN 2 mg CAPSULAS DURAS	Viatris Healthcare Limited	59985	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	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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