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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
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 dinitrateANDA2024-10-08
isosorbide dinitrate and hydralazine hydrochlorideNDA authorized generic2024-07-01
isosorbide mononitrateANDA2024-10-28
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
105 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333HP_0001635I501236618
Coronary artery diseaseD003324I25.115713
Myocardial ischemiaD017202EFO_1001375I20-I25117413
Coronary diseaseD003327115310
Heart diseasesD006331EFO_0003777I51.91348
HypertensionD006973EFO_0000537I10221218
Stable anginaD060050I20.891214
Angina pectorisD000787EFO_0003913I20123
Diabetes mellitusD003920HP_0000819E08-E13213
Portal hypertensionD006975EFO_0000666K76.6213
Show 31 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
IschemiaD007511EFO_0000556112
StrokeD020521EFO_0000712I63.9212
Cerebral small vessel diseasesD059345212
Cardio-renal syndromeD059347112
Ventricular dysfunctionD018754112
Diabetic footD017719EFO_1001459112
UlcerD014456MPATH_579112
Foot ulcerD016523112
SyndromeD013577112
OsteoporosisD010024HP_0000939M81.011
Show 12 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cervical ripeningD020070112
Induced laborD007751122
Missed abortionD000030O02.1112
ProteinuriaD011507HP_0000093R8011
Acute kidney injuryD058186HP_0001919N1711
Wounds and injuriesD014947T14.811
TachycardiaD013610HP_0001649R00.0111
Orthostatic intoleranceD054971111
Cognitive dysfunctionD060825HP_0001268G31.8411
Fontan procedureD01872911
Show 2 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients527
MalnutritionD044342EFO_0008572E40-E4622
Therapeutic equivalencyD01381011
Fissure in anoD005401HP_0012390K60.211
Duchenne muscular dystrophyD020388EFO_000042911
Muscular dystrophiesD009136HP_0003560G71.011
PharmacokineticsD01059911
Habitual abortionD000026EFO_1000954N9611
Indications Without Phase
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
Image (chem structure or protein)Loading
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
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Isosorbide dinitrate
+
Hydralazine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,686 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
Top Adverse Reactions
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14,295 adverse events reported
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