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Trandolapril
Mavik, Tarka (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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
cardiovascular diseasesD002318
endocrine system diseasesD004700
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Trandolapril
Tradename
Company
Number
Date
Products
MAVIKAbbVieN-020528 DISCN1996-04-26
3 products, RLD
Hide discontinued
Trandolapril
+
Verapamil hydrochloride
Tradename
Company
Number
Date
Products
TARKAAbbVieN-020591 DISCN1996-10-22
4 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
mavikNew Drug Application2012-02-14
tarkaNew Drug Application2012-02-13
trandolaprilANDA2022-07-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
diabetic nephropathiesEFO_0000401D003928—
heart failureEFO_0003144D006333I50
hypertensionEFO_0000537D006973I10
left ventricular dysfunction—D018487—
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
Heart failureD006333EFO_0003144I502—25110
HypertensionD006973EFO_0000537I10———4—4
Chronic renal insufficiencyD051436N181——1—2
Cardiovascular diseasesD002318EFO_0000319I98———1—1
Tricuspid valve insufficiencyD014262HP_0005180———1—1
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pre-eclampsiaD011225EFO_0000668O14—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138102————2
Type 2 diabetes mellitusD003924EFO_0001360E111————1
Food-drug interactionsD0185651————1
Renal insufficiencyD051437HP_0000083N191————1
Body weight changesD0018361————1
Healthy volunteers/patients—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EdemaD004487R60.9————22
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTRANDOLAPRIL
INNtrandolapril
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 classantihypertensives (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-ID87679-37-6
RxCUI38454
ChEMBL IDCHEMBL1519
ChEBI ID—
PubChem CID5484727
DrugBankDB00519
UNII ID1T0N3G9CRC (ChemIDplus, GSRS)
Target
Agency Approved
ACE
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 2,529 documents
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Safety
Black-box Warning
Black-box warning for: Mavik, Tarka, Trandolapril
Adverse Events
Top Adverse Reactions
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7,355 adverse events reported
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