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AboutPricing
Drug ReportsIsosorbide
Isosorbide
Bidil, Ismotic, Isordil, Isosorbide, Monoket (isosorbide) is a small molecule pharmaceutical. Isosorbide 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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update 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
Isordil, Isosorbide, Monoket (discontinued: Dilatrate-sr, Imdur, Ismo, Ismotic, Isordil, Isosorbide, Sorbitrate)
Combinations
Bidil, Isosorbide hydralazine
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Isosorbide dinitrate
Tradename
Company
Number
Date
Products
ISORDILBausch Health CompaniesN-012093 RX1988-07-29
2 products, RLD
Show 7 discontinued
Isosorbide
Tradename
Company
Number
Date
Products
ISMOTICAlcon ResearchN-017063 DISCN1982-01-01
1 products
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Isosorbide mononitrate
Tradename
Company
Number
Date
Products
MONOKETGenus LifesciencesN-020215 RX1993-06-30
2 products, RLD
Show 2 discontinued
Hydralazine hydrochloride
+
Isosorbide dinitrate
Tradename
Company
Number
Date
Products
BIDILAzurityN-020727 RX2005-06-23
1 products, RLD, RS
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 mononitrateANDA2025-03-05
lisinoprilANDA2012-10-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
coronary disease—D003327—
angina pectorisEFO_0003913D000787I20
gastroesophageal refluxEFO_0003948D005764K21
diffuse esophageal spasmEFO_1001785D015155K22.4
poisoningEFO_0008546D011041T65.91
cyanosis—D003490R23.0
pulmonary hypertensionEFO_0001361D006976I27.20
malignant hypertensionEFO_1001031D006974—
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
— C01DA14: Isosorbide mononitrate
— 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
No data
Clinical
Clinical Trials
268 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
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
INNisosorbide
Description
Isosorbide is an organic molecular entity.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O[C@H]1CO[C@@H]2[C@H](O)CO[C@H]12
Identifiers
PDB—
CAS-ID652-67-5
RxCUI—
ChEMBL IDCHEMBL1200660
ChEBI ID—
PubChem CID12597
DrugBankDB09401
UNII IDWXR179L51S (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 63,126 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
Top Adverse Reactions
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5,989 adverse events reported
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