Isordil

(Isosorbide Dinitrate)

ApprovedSmall molecule

Isosorbide dinitrate is used to prevent and relieve chest pain caused by heart disease by relaxing blood vessels and improving blood flow to the heart.[2] Isordil is currently approved and in use across 13 indications[4].[1]

Isordil is one of 291 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

Total Trials

Active Trials

290

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceCompleted

Coronary Artery DiseaseActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Coronary StenosisActive, not recruiting

HemorrhoidActive, not recruiting

Anal FissureActive, not recruiting

Acute Coronary SyndromeActive, not recruiting

Angina PectorisActive, not recruiting

Pulmonary EdemaActive, not recruiting

PancreatitisActive, not recruiting

Insulin ResistanceApproved

Completed

Coronary Artery DiseaseApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Coronary StenosisApproved

Active, not recruiting

HemorrhoidApproved

Active, not recruiting

Anal FissureApproved

Active, not recruiting

Acute Coronary SyndromePreclinical

Active, not recruiting

Angina PectorisApproved

Active, not recruiting

Pulmonary EdemaApproved

Active, not recruiting

PancreatitisPreclinical

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

Isordil

AstraZeneca

Approved

3 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Medrol

Pfizer

Preclinical

1 5

Amidate

Pfizer

Preclinical

1 6

Zemplar

Adriamycin

Savaysa

Xifaxan

2 10

Xylocaine

MMEDRx USA, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Treatment

NCT06218199

Q2 2027

ApprovedRecruiting

Pulmonary Edema

NCT05276219

Q4 2029

PreclinicalActive, not recruiting

Tachycardia

NCT00262470

Clinical

Trials by Indication[1]

Heart Failure3 trials

Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure

Unknown status·UUniversity of Cape Town·Phase 3·NCT01822808·500 enrolled

Hypertensive Heart Failure Treatment in SSA

Completed·UUniversity of Abuja·Phase 4·NCT06400784·50 enrolled

Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction

Completed·—·Phase 2·NCT01516346·44 enrolled

Exercise1 trial

Nitrate Effect on Exercise Capacitance

Completed·—·Phase 2·NCT04297241·20 enrolled

Intravenous1 trial

Adequate Hydration Therapy Combined With Intravenous Infusion of Isosorbide Dinitrate Prevention for CIN

Unknown status·—·N/A·NCT02718521·400 enrolled

Treatment1 trial

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Recruiting·HHeart Center Research, LLC·Phase 4·NCT06218199·80 enrolled

Efficacy1 trial

Short-term Efficacy of Furosemide, Isosorbide Dinitrate and Their Combination in ADHF

Withdrawn·—·N/A·NCT02649998

13 more indications

Ischemia1 trial

Asymptomatic Cardiac Ischemia Pilot (ACIP) Study

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000478

Hemodynamic1 trial

Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects

Completed·MMedical University of Vienna·N/A·NCT00810381·14 enrolled

Coronary Stenosis1 trial

A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis

Completed·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·Phase 4·NCT01513070·120 enrolled

Pancreatitis1 trial

Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis

Unknown status·TTehran University of Medical Sciences·N/A·NCT02368795·400 enrolled

Diabetic Foot1 trial

Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers

Completed·UUniversity of Guadalajara·Phase 3·NCT02789033·68 enrolled

Tics1 trial

To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20

Completed·PParent Project, Italy·Phase 1·NCT01478022·12 enrolled

Indomethacin1 trial

Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention

Unknown status·—·N/A·NCT04425993·2,700 enrolled

Insulin resistance1 trial

Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease

Completed·UUkrainian Medical Stomatological Academy·Phase 4·NCT03011775·43 enrolled

Death1 trial

Medical Management of Late Intrauterine Death.

Completed·NNational Institute of Perinatology·Phase 4·NCT02488642·60 enrolled

Acute Coronary Syndrome1 trial

Intensive Arterial Pressure Control in Acute Coronary Syndrome

Completed·UUniversity of Monastir·N/A·NCT02135315·1,500 enrolled

CAR1 trial

Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study

Unknown status·NNational University Hospital, Singapore·Phase 3·NCT02343393·100 enrolled

Pulmonary Edema1 trial

Vasodilatation or Loop-Diuretics for Initial Treatment of Pulmonary Congestion Due to Acute Heart Failure - A Randomized Placebo-Controlled Trial

Recruiting·JJohannes Grand·Approved·NCT05276219·1,041 enrolled

Tachycardia1 trial

Treatment of Orthostatic Intolerance

Active, not recruiting·SSatish R. Raj·Preclinical·NCT00262470·150 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 29, 1988

ISORDIL

NDA NDA012093

Jul 29, 1988

ISORDIL

NDA NDA012882

Jul 29, 1988

ISORDIL

NDA NDA012940

Sep 2, 1988

DILATRATE-SR

NDA NDA019790

Apr 1, 1996

SORBITRATE

NDA NDA016192

Apr 1, 1996

SORBITRATE

NDA NDA016776

Apr 1, 1996

SORBITRATE

NDA NDA016191

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Isosorbide Dinitrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Isordil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Isosorbide Dinitrate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Isosorbide Dinitrate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA016192). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Soluble Guanylate Cyclase Activator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Isordil

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2029

Trials by Indication[1]

Heart Failure3 trials

Exercise1 trial

Intravenous1 trial

Treatment1 trial

Efficacy1 trial

Ischemia1 trial

Hemodynamic1 trial

Coronary Stenosis1 trial

Pancreatitis1 trial

Diabetic Foot1 trial

Tics1 trial

Indomethacin1 trial

Insulin resistance1 trial

Death1 trial

Acute Coronary Syndrome1 trial

CAR1 trial

Pulmonary Edema1 trial

Tachycardia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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