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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Fosinopril (discontinued: Fosinopril, Monopril)
CombinationsFosinopril 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 |
|---|---|---|---|---|
| MONOPRIL | Bristol Myers Squibb | N-019915 DISCN | 1991-05-16 | 3 products, RLD |
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Fosinopril sodium
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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 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
19 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 | — | 3 | 4 | 8 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 1 | 1 | 1 | — | 3 |
| Covid-19 | D000086382 | — | — | — | — | — | 1 | 1 | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | 1 | — | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 1 | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 1 | 1 | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | 1 | 1 | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | 1 | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | — | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | 1 | — | — | 2 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | — | — | — | 1 |
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 | — | — | — | — | — | — | — | 4 | 4 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Essential hypertension | D000075222 | — | I10 | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 1 | 1 |
| Hyperinsulinism | D006946 | HP_0000842 | E16.1 | — | — | — | — | 1 | 1 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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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
ACE
Organism
Homo sapiens
Gene name
ACE
Gene synonyms
DCP, DCP1
NCBI Gene ID
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
Mouse ortholog
Ace (11421)
angiotensin-converting enzyme (P09470)
Alternate
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Variants
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Financial
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Estimated US medical usage
Fosinopril
Total medical expenditures per year (USD, in millions)
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Fosinopril
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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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Price per prescription (USD)
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Trends
PubMed Central
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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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1,204 adverse events reported
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