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AboutPricing
Drug ReportsFosinopril
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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Events Timeline
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3M
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YTD
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
cardiovascular diseasesD002318
endocrine system diseasesD004700
Trade Name
FDA
EMA
Fosinopril (discontinued: Fosinopril, Monopril)
Combinations
Fosinopril hydrochlorothiazide (discontinued: Fosinopril hydrochlorothiazide, Monopril-hct)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fosinopril sodium
Tradename
Company
Number
Date
Products
MONOPRILBristol Myers SquibbN-019915 DISCN1991-05-16
3 products, RLD
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Fosinopril sodium
+
Hydrochlorothiazide
Tradename
Company
Number
Date
Products
MONOPRIL-HCTBristol Myers SquibbN-020286 DISCN1994-11-30
2 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
fosinopril sodiumANDA2025-10-10
fosinopril sodium and hydrochlorothiazideANDA2024-04-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
diabetic nephropathiesEFO_0000401D003928—
hypertensionEFO_0000537D006973I10
left ventricular dysfunction—D018487—
nephrotic syndromeEFO_0004255D009404N04
edema—D004487R60.9
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
Clinical Trials
20 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———————44
DiseaseD004194EFO_0000408R69————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFosinopril
INNfosinopril
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 classphosphoro-derivatives; antihypertensives (ACE inhibitors)
Image (chem structure or protein)Loading
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-ID98048-97-6
RxCUI—
ChEMBL IDCHEMBL3039598
ChEBI ID—
PubChem CID55891
DrugBankDB00492
UNII IDR43D2573WO (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
No data
Financial
Revenue by drug
$
€
£
₣
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Estimated US medical usage
Fosinopril
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Price per prescription (USD)
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Fosinopril
+
Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,146 documents
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Safety
Black-box Warning
Black-box warning for: Fosinopril sodium, Fosinopril sodium and hydrochlorothiazide
Adverse Events
Top Adverse Reactions
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1,327 adverse events reported
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