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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
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FDA approval date
EMA approval date
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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
Hide discontinued
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 mononitrateANDA2025-04-04
lisinoprilANDA2012-10-12
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
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10713414644
Heart failureD006333EFO_0003144I5045814940
Coronary artery diseaseD003324—I25.11——6815
Myocardial ischemiaD017202EFO_1001375I20-I251—18515
Healthy volunteers/patients———12——1215
Coronary diseaseD003327——1—15411
Heart diseasesD006331EFO_0003777I51.9——15410
Diabetes mellitusD003920EFO_0000400E08-E131123310
SyndromeD013577——121149
Essential hypertensionD000075222—I10—512—8
Show 84 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney diseasesD007674EFO_0003086N08181—313
Chronic renal insufficiencyD051436—N18161——8
Cardio-renal syndromeD059347———11—13
Cerebral small vessel diseasesD059345———21—13
Covid-19D000086382—U07.1—11——2
Acute kidney injuryD058186—N17—11——2
Coronavirus infectionsD018352EFO_0007224B34.2——2——2
OsteoporosisD010024EFO_0003882M81.0——1—12
Cardiovascular diseasesD002318EFO_0000319I98——1—12
Left ventricular dysfunctionD018487———11——2
Show 24 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Polycystic ovary syndromeD011085EFO_0000660E28.241——16
Diabetic nephropathiesD003928EFO_0000401——2———2
Wounds and injuriesD014947—T14.8—2———2
Pancreatic neoplasmsD010190EFO_0003860C25—2———2
Cervical ripeningD020070———1——12
Induced laborD007751——12———2
Missed abortionD000030—O02.111———2
ProteinuriaD011507—R80—1———1
Wet macular degenerationD057135EFO_0004683——1———1
CarcinomaD002277—C80.0—1———1
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperandrogenismD017588——3———14
MalnutritionD044342EFO_0008572E40-E463————3
Therapeutic equivalencyD013810——2————2
PubertyD011627EFO_0001382—2————2
PharmacokineticsD010599——2————2
Pure autonomic failureD054970——1————1
Glucose metabolism disordersD044882——1————1
Metabolic diseasesD008659EFO_0000589E88.91————1
Endocrine system diseasesD004700EFO_0001379E34.91————1
FastingD005215EFO_0002756—1————1
Show 7 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9————44
HeadacheD006261—R51————33
Membranous glomerulonephritisD015433EFO_0004254N03.2————33
AdenomaD000236——————22
Stomatognathic diseasesD009057—K08.9————22
PancreatitisD010195EFO_0000278K85————22
Atopic dermatitisD003876EFO_0000274L20————22
DermatitisD003872—L30.9————22
Acute painD059787—R52————22
Neck painD019547—M54.2————22
Show 110 more
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 63,437 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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