Isosorbide

Generic Name: Isosorbide

Drug Type: Small Molecule

Chemical Formula: C_₆H_₁₀O_₄

CAS Number: 652-67-5

Unique Ingredient Identifier: WXR179L51S

Background: Isosorbide was previously available in an oral formulation for the reduction of intraocular pressure. It was approved by the FDA in 1980, but has since been discontinued. Currently, isosorbide is an organic nitrate currently available in the isosorbide mononitrate and isosorbide dinitrate forms, and is used for the prevention of angina. Refer to these drug entries for more information.

Indication: Isosorbide was previously indicated for temporary reduction of intraocular pressure and used to interrupt an acute glaucoma attack, however, this is not a currently approved indication. Refer to isosorbide mononitrate and isosorbide dinitrate drug entries for more isosorbide indications.

Associated Conditions: Angina Pectoris

Clinical Trials

Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris

Phase 4

Conditions: Coronary Heart Disease
Unstable Angina
Chinese Herbal Medicine

Interventions: Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
Drug: Wen Xin granule
Drug: Atorvastatin Calcium
Drug: Isosorbide Mononitrate Tab 20 MG
Drug: Metoprolol Tartrate Tab 25 MG
Drug: Aspirin Enteric-coated Tablets
Drug: WXG placebo
Drug: Trimetazidine Dihydrochloride Tablets
Drug: glyceryl trinitrate

First Posted Date: 2020-12-10

Last Posted Date: 2021-01-25

Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Target Recruit Count: 502

Registration Number: NCT04661709

Isosorbide Mononitrate in Induction of Labour

Early Phase 1

Conditions: Labor Fast

Interventions: Drug: Isosorbide Mononitrate 40 MG
Drug: Isosorbide Mononitrate 60 MG
Drug: Misoprostol

First Posted Date: 2020-07-23

Last Posted Date: 2020-07-23

Lead Sponsor: Aljazeera Hospital

Target Recruit Count: 130

Registration Number: NCT04482881

Locations: 🇪🇬
Algazeerah, Giza, Egypt

Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention

Not Applicable

Conditions: Post-ERCP Acute Pancreatitis

Interventions: Drug: Isosorbide Dinitrate 5 MG
Drug: Indomethacin 100 MG
Drug: Rectal placebo
Drug: Sublingual Placebo

First Posted Date: 2020-06-11

Last Posted Date: 2020-10-22

Lead Sponsor: Air Force Military Medical University, China

Target Recruit Count: 2700

Registration Number: NCT04425993

Locations: 🇨🇳
Xijing Hoapital, Xi'an, Shaanxi, China
🇨🇳
Lanzhou University Second Hospital, Lanzhou, Gansu, China
🇨🇳
Xi'an Central Hospital, Xi'an, Shaanxi, China

and more 1 locations

Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion

Phase 3

Conditions: Contraception

Interventions: Drug: Placebo
Drug: Isosorbide Mononitrate 40 MG

First Posted Date: 2020-03-17

Last Posted Date: 2020-03-17

Lead Sponsor: Cairo University

Target Recruit Count: 88

Registration Number: NCT04311658

Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts

Phase 4

Completed

Conditions: Antispastic Therapy
Coronary Artery Bypass Graft
Radial Artery Grafts
Pilot Study

Interventions: Drug: Nicorandil 5mg tid
Drug: Isosorbide Mononitrate 50mg qd
Drug: Diltiazem 180mg qd

First Posted Date: 2020-03-17

Last Posted Date: 2024-12-12

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 150

Registration Number: NCT04310995

Locations: 🇨🇳
Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China

Multiomics After Headache Provocation of People Who Are Unable to Have Headache

Not Applicable

Completed

Conditions: Headache
Healthy

Interventions: Drug: Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]
Other: Blood sample

First Posted Date: 2020-01-06

Last Posted Date: 2021-03-25

Lead Sponsor: Danish Headache Center

Target Recruit Count: 58

Registration Number: NCT04218760

Locations: 🇩🇰
Danish Headache Center, Glostrup, Region H, Denmark

Headache Provocation of People Who Are Unable to Have Headache

Not Applicable

Completed

Conditions: Headache
Healthy

Interventions: Drug: Isosorbide Mononitrate 60 MG

First Posted Date: 2020-01-03

Last Posted Date: 2021-03-25

Lead Sponsor: Danish Headache Center

Target Recruit Count: 58

Registration Number: NCT04217668

Locations: 🇩🇰
Danish Headache Center, Glostrup, Region H, Denmark

Intravaginal Isosorbide Mononitrate in Addition to Misoprostol Versus Misoprostol Only for Induction of Labor

Phase 1

Conditions: Induction of Labor

Interventions: Drug: Isosorbide Mononitrate 40 MG to study group

First Posted Date: 2018-05-14

Last Posted Date: 2018-08-07

Lead Sponsor: Dina Yahia Mansour

Target Recruit Count: 50

Registration Number: NCT03523754

Locations: 🇪🇬
Department of Obs & Gyn,Faculty of Medicine, Ain shams University., Cairo, Egypt

LACunar Intervention (LACI-2) Trial-2

Phase 2

Completed

Conditions: Cerebral Small Vessel Diseases
Stroke, Lacunar

Interventions: Drug: Isosorbide Mononitrate XL (ISMN)
Drug: ISMN XL and Cilostazol
Other: Neither ISMN nor cilostazol
Drug: Cilostazol

First Posted Date: 2018-03-02

Last Posted Date: 2024-11-11

Lead Sponsor: University of Edinburgh

Target Recruit Count: 363

Registration Number: NCT03451591

Locations: 🇬🇧
Royal Infirmary, Edinburgh, Lothian, United Kingdom

Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients

Phase 1

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: Vericiguat (BAY1021189)
Drug: Placebo
Drug: Isosorbide mononitrate (ISMN)

First Posted Date: 2017-08-21

Last Posted Date: 2021-12-29

Lead Sponsor: Bayer

Target Recruit Count: 41

Registration Number: NCT03255512

Locations: 🇩🇪
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
🇩🇪
Medizinische Einrichtungen der Universität Bonn, Bonn, Nordrhein-Westfalen, Germany
🇩🇪
SocraTec R&D GmbH, Erfurt, Thüringen, Germany

and more 3 locations

Drug Development Updates

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