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Isosorbide mononitrate
Bidil, Ismotic, Isordil, 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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
Trade Name
FDA
EMA
Isordil, Monoket (generic drugs available since 1987-03-12, discontinued: Dilatrate-sr, Imdur, Ismo, Ismotic, Sorbitrate)
Combinations
Bidil (generic drugs available since 1987-03-12)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydralazine hydrochloride
+
Isosorbide dinitrate
Tradename
Company
Number
Date
Products
BIDILAzurityN-020727 RX2005-06-23
1 products, RLD, RS
Isosorbide
Tradename
Company
Number
Date
Products
ISMOTICAlcon ResearchN-017063 DISCN1982-01-01
1 products
Hide discontinued
Isosorbide dinitrate
Tradename
Company
Number
Date
Products
ISORDILBausch Health CompaniesN-012093 RX1988-07-29
2 products, RLD
Show 7 discontinued
Isosorbide mononitrate
Tradename
Company
Number
Date
Products
MONOKETECI PharmaceuticalsN-020215 RX1993-06-30
2 products, RLD
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bidilNew Drug Application2022-07-19
ismotic2006-03-23
isordilNew Drug Application2019-08-08
isosorbide mononitrateANDA2022-10-31
monoketNew Drug Application2015-02-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
angina pectorisEFO_0003913D000787I20
coronary diseaseD003327
cyanosisD003490R23.0
diffuse esophageal spasmEFO_1001785D015155K22.4
gastroesophageal refluxEFO_0003948D005764K21
heart failureEFO_0003144D006333I50
poisoningEFO_0008546D011041T65.91
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
C01DA14: Isosorbide mononitrate
HCPCS
No data
Clinical
Clinical Trials
68 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I50121318
Coronary diseaseD0033271214
Coronary artery diseaseD003324I25.1134
Portal hypertensionD006975EFO_0000666K76.6112
Unstable anginaD000789EFO_1000985I20.011
Metabolic syndromeD024821EFO_0000195E88.8111
Coronary stenosisD023921EFO_100088211
Pre-eclampsiaD011225EFO_0000668O1411
Premature obstetric laborD007752O6011
Coronary artery bypassD001026EFO_000377611
Show 6 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cerebral small vessel diseasesD059345212
Cardio-renal syndromeD059347112
ContraceptionD00326711
RuptureD01242111
Lacunar strokeD059409I63.81111
Diabetic footD017719EFO_100145911
OligohydramniosD016104EFO_0007401O41.0111
Stable anginaD060050I20.811
Left ventricular dysfunctionD01848711
Cardiovascular diseasesD002318EFO_0000319I9811
Show 2 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10224
Cervical ripeningD020070112
Induced laborD007751122
ProteinuriaD011507HP_0000093R8011
Acute kidney injuryD058186HP_0001919N1711
TachycardiaD013610HP_0001649R00.0111
Orthostatic intoleranceD054971111
StrokeD020521EFO_0000712I63.911
Cognitive dysfunctionD060825G31.8411
Missed abortionD000030O02.111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients527
Therapeutic equivalencyD01381011
Fissure in anoD005401HP_0012390K60.211
Duchenne muscular dystrophyD02038811
PharmacokineticsD01059911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atopic dermatitisD003876EFO_0000274L2022
HeadacheD006261HP_0002315R5122
ObesityD009765EFO_0001073E66.911
Type 2 diabetes mellitusD003924EFO_0001360E1111
GlaucomaD005901EFO_0000516H4011
Migraine disordersD008881EFO_0003821G4311
PancreatitisD010195EFO_0000278K8511
Acute coronary syndromeD054058EFO_000567211
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
Image (chem structure or protein)
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
RxCUI28004
ChEMBL IDCHEMBL1311
ChEBI ID6062
PubChem CID27661
DrugBankDB01020
UNII IDLX1OH63030 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 7,589 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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11,075 adverse events reported
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