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Drug ReportsIsosorbide dinitrate
Isosorbide dinitrate
Bidil, Ismotic, Isordil, Isosorbide, Monoket (isosorbide dinitrate) is a small molecule pharmaceutical. Isosorbide dinitrate 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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Events Timeline
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FDA approval 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 dinitrateANDA2025-01-10
isosorbide dinitrate and hydralazine hydrochlorideNDA authorized generic2024-07-01
isosorbide mononitrateNDA authorized generic2025-02-12
lisinoprilANDA2012-10-12
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
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
— C01DA08: Isosorbide dinitrate
— C01DA58: Isosorbide dinitrate, combinations
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AE: Muscle relaxants for treatment of hemorrhoids and anal fissures for topical use
— C05AE02: Isosorbide dinitrate
HCPCS
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Clinical
Clinical Trials
109 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
Coronary diseaseD003327——1————1
Coronary artery diseaseD003324—I25.11————1
Myocardial ischemiaD017202EFO_1001375I20-I251————1
HypertensionD006973EFO_0000537I101————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIsosorbide dinitrate
INNisosorbide dinitrate
Description
Isosorbide dinitrate is a nitrate ester and a glucitol derivative. It has a role as a vasodilator agent and a nitric oxide donor.
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]1OC[C@H]2O[N+](=O)[O-]
Identifiers
PDB—
CAS-ID87-33-2
RxCUI—
ChEMBL IDCHEMBL6622
ChEBI ID6061
PubChem CID6883
DrugBankDB00883
UNII IDIA7306519N (ChemIDplus, GSRS)
Target
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Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Isosorbide dinitrate
+
Hydralazine
Total medical expenditures per year (USD, in millions)
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Isosorbide dinitrate
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,878 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
Top Adverse Reactions
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14,743 adverse events reported
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