Trandolapril - PharmaKB

Trandolapril

Trandolapril (trandolapril) is a small molecule pharmaceutical. Trandolapril was first approved as Mavik on 1996-04-26. It is used to treat diabetic nephropathies, heart failure, hypertension, and left ventricular dysfunction in the USA. The pharmaceutical is active against angiotensin-converting enzyme.

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Drug

Target

Variants

Financial

Trends

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Events Timeline

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
urogenital diseases	D000091642
cardiovascular diseases	D002318
endocrine system diseases	D004700

Trade Name

FDA

EMA

Trandolapril (discontinued: Mavik, Trandolapril)

Combinations

Trandolapril verapamil (discontinued: Tarka)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Trandolapril

Tradename	Company	Number	Date	Products
MAVIK	AbbVie	N-020528 DISCN	1996-04-26	3 products, RLD

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Trandolapril

Verapamil hydrochloride

Tradename	Company	Number	Date	Products
TARKA	AbbVie	N-020591 DISCN	1996-10-22	4 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
mavik	New Drug Application	2012-02-14
tarka	New Drug Application	2012-02-13
trandolapril	ANDA	2025-09-05
trandolapril and verapamil hydrochloride	ANDA	2019-09-30

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	EFO_0003144	D006333	I50
diabetic nephropathies	EFO_0000401	D003928	—
hypertension	EFO_0000537	D006973	I10
left ventricular dysfunction	—	D018487	—
atrial fibrillation	EFO_0000275	D001281	I48.0
myocardial infarction	EFO_0000612	D009203	I21
atrial flutter	EFO_0003911	D001282	—
supraventricular tachycardia	—	D013617	I47.1
variant angina pectoris	—	D000788	I20.1

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

C: Cardiovascular system drugs

— C09: Agents acting on the renin-angiotensin system

— C09A: Ace inhibitors, plain

— C09AA: Ace inhibitors, plain

— C09AA10: Trandolapril

— C09B: Ace inhibitors, combinations

— C09BB: Ace inhibitors and calcium channel blockers

— C09BB10: Trandolapril and verapamil

HCPCS

No data

Clinical

Clinical Trials

26 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	—	—	1	9	5	15
Covid-19	D000086382	—	U07.1	—	—	1	1	1	3
Heart failure	D006333	EFO_0003144	I50	—	—	1	1	—	2
Metabolic syndrome	D024821	EFO_0000195	E88.810	—	—	—	2	—	2
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	—	—	2	—	2
Hypotension	D007022	EFO_0005251	I95	—	—	—	1	1	2
Coronavirus infections	D018352	EFO_0007224	B34.2	—	—	—	1	—	1
Cardiovascular diseases	D002318	EFO_0000319	I98	—	—	—	1	—	1
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	—	—	1	—	1
Heart diseases	D006331	EFO_0003777	I51.9	—	—	—	1	—	1

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Obesity	D009765	EFO_0001073	E66.9	—	—	1	—	1	2
Pneumonia	D011014	EFO_0003106	J18	—	—	1	—	—	1
Body-weight trajectory	D000077962	—	—	—	—	1	—	—	1

Indications Phases 2

No data

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	4	—	—	—	—	4
Malnutrition	D044342	EFO_0008572	E40-E46	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Essential hypertension	D000075222	—	I10	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Trandolapril
INN	trandolapril
Description	Trandolapril is a heterobicylic compound that is (2S,3aR,7aS)-1-[(2S)-2-aminopropanoyl]octahydro-1H-indole-2-carboxylic acid in which the hydrogen of the amino group is substituted by a (2R)-1-ethoxy-1-oxo-4-phenylbutan-2-yl group. It is a angiotensin-converting enzyme inhibitor and a prodrug used for the treatment of hypertension. It has a role as a prodrug, an antihypertensive agent and an EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor. It is a dicarboxylic acid monoester, a dipeptide, an ethyl ester, a secondary amino compound, a tertiary carboxamide and an organic heterobicyclic compound. It is functionally related to a trandolaprilat.
Classification	Small molecule
Drug class	antihypertensives (ACE inhibitors)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCOC(=O)[C@H](CCc1ccccc1)N[C@@H](C)C(=O)N1[C@H](C(=O)O)C[C@H]2CCCC[C@@H]21

Identifiers

PDB	—
CAS-ID	87679-37-6
RxCUI	—
ChEMBL ID	CHEMBL1519
ChEBI ID	—
PubChem CID	5484727
DrugBank	DB00519
UNII ID	1T0N3G9CRC (ChemIDplus, GSRS)

Target

Agency Approved

ACE

Organism

Homo sapiens

Gene name

ACE

Gene synonyms

DCP, DCP1

NCBI Gene ID

1636

Protein name

angiotensin-converting enzyme

Protein synonyms

angiotensin I converting enzyme (peptidyl-dipeptidase A) 1, carboxycathepsin, CD143, CD143 antigen, dipeptidyl carboxypeptidase 1, Dipeptidyl carboxypeptidase I, Kininase II, peptidase P

Uniprot ID

Q7M4L4

Mouse ortholog

Ace (11421)

angiotensin-converting enzyme (P09470)

Alternate

No data

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Trandolapril

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Trandolapril

Verapamil

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Refill frequency

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Safety

Black-box Warning

Black-box warning for: Mavik, Tarka, Trandolapril, Trandolapril and verapamil hydrochloride

Adverse Events

Top Adverse Reactions

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1,915 adverse events reported

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