Fosinopril - PharmaKB

Fosinopril

Fosinopril (fosinopril) is a small molecule pharmaceutical. Fosinopril was first approved as Monopril on 1991-05-16. 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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Therapeutic Areas

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

Trade Name

FDA

EMA

Fosinopril (discontinued: Fosinopril, Monopril)

Combinations

Fosinopril hydrochlorothiazide (discontinued: Fosinopril hydrochlorothiazide, Monopril-hct)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Fosinopril sodium

Tradename	Company	Number	Date	Products
MONOPRIL	Bristol Myers Squibb	N-019915 DISCN	1991-05-16	3 products, RLD

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Fosinopril sodium

Hydrochlorothiazide

Tradename	Company	Number	Date	Products
MONOPRIL-HCT	Bristol Myers Squibb	N-020286 DISCN	1994-11-30	2 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
fosinopril sodium	ANDA	2024-10-28
fosinopril sodium and hydrochlorothiazide	ANDA	2024-04-28

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	HP_0001635	D006333	I50
diabetic nephropathies	EFO_0000401	D003928	—
hypertension	EFO_0000537	D006973	I10
left ventricular dysfunction	—	D018487	—
nephrotic syndrome	EFO_0004255	D009404	N04
edema	HP_0000969	D004487	R60.9

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

— C09AA09: Fosinopril

— C09B: Ace inhibitors, combinations

— C09BA: Ace inhibitors and diuretics

— C09BA09: Fosinopril and diuretics

HCPCS

No data

Clinical

No data

Drug

General

Drug common name	Fosinopril
INN	fosinopril
Description	Fosinopril is a phosphinate ester-containing N-acyl derivative of (4S)-cyclohexyl-L-proline. It is used for the treatment of hypertension and heart failure. A pro-drug, it is hydrolysed in vivo to the corresponding phosphininc acid, fosinoprilat, which is the active metabolite. It has a role as an EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor, a prodrug and an antihypertensive agent. It is a phosphinic ester and a L-proline derivative. It is functionally related to a fosinoprilat. It is a conjugate acid of a fosinopril(1-).
Classification	Small molecule
Drug class	phosphoro-derivatives; antihypertensives (ACE inhibitors)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCC(=O)O[C@@H](O[P@](=O)(CCCCc1ccccc1)CC(=O)N1C[C@H](C2CCCCC2)C[C@H]1C(=O)O)C(C)C

Identifiers

PDB	—
CAS-ID	98048-97-6
RxCUI	—
ChEMBL ID	CHEMBL3039598
ChEBI ID	—
PubChem CID	55891
DrugBank	DB00492
UNII ID	R43D2573WO (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

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Financial

Revenue by drug

€

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No data

Estimated US medical usage

Fosinopril

Total medical expenditures per year (USD, in millions)

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Fosinopril

Hydrochlorothiazide

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Tabular view

Trends

No data

Safety

Black-box Warning

Black-box warning for: Fosinopril sodium, Fosinopril sodium and hydrochlorothiazide

Adverse Events

0 adverse events reported