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Drug ReportsIsosorbide mononitrate
Isosorbide mononitrate
Bidil, Ismotic, Isordil, Isosorbide, Monoket (isosorbide mononitrate) is a small molecule pharmaceutical. Isosorbide mononitrate was first approved as Ismotic on 1982-01-01. It is used to treat angina pectoris, coronary disease, cyanosis, diffuse esophageal spasm, and gastroesophageal reflux amongst others in the USA.
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Safety
Events Timeline
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FDA approval date
EMA approval date
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Study first post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
bidilNew Drug Application2022-07-19
dilatrate-sr2008-01-23
ismo2007-03-31
ismotic2006-03-23
isordilNew Drug Application2019-08-08
isosorbideANDA2018-11-30
isosorbide dinitrateANDA2025-01-07
isosorbide dinitrate and hydralazine hydrochlorideNDA authorized generic2024-07-01
isosorbide mononitrateANDA2024-12-18
lisinoprilANDA2012-10-12
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01D: Vasodilators used in cardiac diseases
— C01DA: Organic nitrates used in cardiac disease
— C01DA14: Isosorbide mononitrate
HCPCS
No data
Clinical
Clinical Trials
266 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I102————2
MalnutritionD044342EFO_0008572E40-E461————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIsosorbide mononitrate
INNisosorbide mononitrate
Description
Isosorbide mononitrate is a nitrate ester and a glucitol derivative. It has a role as a nitric oxide donor and a vasodilator agent.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
O=[N+]([O-])O[C@@H]1CO[C@@H]2[C@@H](O)CO[C@H]12
Identifiers
PDB—
CAS-ID16051-77-7
RxCUI—
ChEMBL IDCHEMBL1311
ChEBI ID6062
PubChem CID27661
DrugBankDB01020
UNII IDLX1OH63030 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Isosorbide mononitrate
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 61,557 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
Top Adverse Reactions
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14,729 adverse events reported
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