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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
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start 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
Isordil, Isosorbide (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
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
ISMOPromius PharmaN-019091 DISCN1991-12-30
1 products
IMDURMerck & CoN-020225 DISCN1993-08-12
3 products, RLD
Hide 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 dinitrateANDA2025-09-18
isosorbide dinitrate and hydralazine hydrochlorideANDA2025-06-03
isosorbide mononitrateANDA2025-10-01
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
207 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I5011———2
HyperkalemiaD006947—E87.5—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————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 9,900 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
Top Adverse Reactions
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6,079 adverse events reported
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