Imdur

(Isosorbide mononitrate)

ApprovedSmall molecule

Isosorbide mononitrate is used to prevent and treat chest pain (angina) caused by heart disease. It works by relaxing blood vessels to improve blood flow to the heart.[2] Imdur is currently approved and in use across 19 indications[4].[1]

Imdur is one of 407 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

406

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

ContraceptionApproved

Cardiovascular DiseaseActive, not recruiting

Left Ventricular HypertrophyActive, not recruiting

Premature Rupture of MembranesApproved

HydrocephalusActive, not recruiting

Anal FissureActive, not recruiting

StrokeActive, not recruiting

OligohydramniosActive, not recruiting

Angina PectorisActive, not recruiting

Coronary Artery DiseasePhase 1

Active, not recruiting

ContraceptionApproved

Approved

Cardiovascular DiseaseApproved

Active, not recruiting

Left Ventricular HypertrophyPhase 2

Active, not recruiting

Premature Rupture of MembranesApproved

Approved

HydrocephalusApproved

Active, not recruiting

Anal FissurePhase 1

Active, not recruiting

StrokePhase 3

Active, not recruiting

OligohydramniosPhase 2

Active, not recruiting

Angina PectorisApproved

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

687 competitors in Heart Failure

#DrugCompanyPhaseTrials

Imdur

OOmnivium

Approved

1 2

Amidate

Pfizer

Preclinical

1 3

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

4 4

Xifaxan

SSalix

Preclinical

2 5

Zoloft

VViatris Specialty LLC

Preclinical

2 6

Neo-Synephrine

EExela Pharma Sciences, LLC.

Sulfonylureas

1 8

Thiazolidinediones

Sanofi

Preclinical

1 9

Alpha-Glucosidase Inhibitors

Sanofi

Preclinical

1 10

Meglitinides

Sanofi

Preclinical

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

Timeline

Expected Milestones

Q3 2026

N/AActive, not recruiting

Randomized Controlled Trial

NCT07121634

Q1 2028

Phase 3Not yet recruiting

Stroke

NCT07252544

Q1 2030

Phase 1/2Not yet recruiting

Intestinal Cancer

NCT07456852

Clinical

Trials by Indication[1]

Induction of Labor3 trials

Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women

Unknown status·AAbdelrahman Ali Fadel Youssef Mohamed·Phase 2·NCT03854383·100 enrolled

Nitric Oxide Donor Isosorbide Mono Nitrate for Induction of Labor With Pre-labor Rupture of Membranes

Completed·Aahmed nagy shaker ramadan·Phase 3·NCT03665779·140 enrolled

Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor

Completed·Aahmed nagy shaker ramadan·Phase 4·NCT03544606·160 enrolled

Trial2 trials

Lacunar Intervention Trial 1 (LACI-1)

Completed·UUniversity of Edinburgh·Phase 2·NCT02481323·57 enrolled

Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects

Withdrawn·BBiolab Sanus Farmaceutica·Phase 1·NCT04729088

Headache2 trials

Headache Provocation of People Who Are Unable to Have Headache

Completed·DDanish Headache Center·N/A·NCT04217668·58 enrolled

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

Completed·DDanish Headache Center·N/A·NCT04218760·58 enrolled

Intestinal Cancer1 trial

Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy

Not yet recruiting·MMayo Clinic·Phase 1/2·NCT07456852·60 enrolled

Anal fissure1 trial

PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure

Withdrawn·BBiolab Sanus Farmaceutica·Phase 1·NCT02667535

17 more indications

Pregnancy1 trial

Termination Of Anembryonic Pregnancy

Withdrawn·—·Phase 2·NCT02573051

Prophylaxis1 trial

Secondary Prophylaxis After Variceal Bleeding in Non-Responders

Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 4·NCT00450164·50 enrolled

Cesarean Section1 trial

Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section

Unknown status·—·N/A·NCT03587077·113 enrolled

Oligohydramnios1 trial

Nitric Oxide Donors for Treatment of Isolated Oligohydramnios

Completed·—·Phase 2/3·NCT02712125·100 enrolled

Heart Failure1 trial

Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction

Completed·AAdrian Hernandez·Phase 2·NCT02053493·110 enrolled

Pain1 trial

the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion

Completed·—·Phase 3·NCT04312048·110 enrolled

Randomized Controlled Trial1 trial

Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial

Active, not recruiting·RRaid M. Al-Ani·N/A·NCT07121634·80 enrolled

Abortion1 trial

Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

Completed·—·Phase 4·NCT03407521·60 enrolled

Kidney Injury1 trial

Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury

Terminated·TThe University of Texas Health Science Center, Houston·Phase 2·NCT04051957·9 enrolled

ART1 trial

Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients With URPL

Unknown status·—·Phase 1·NCT05341856·60 enrolled

Stroke1 trial

Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)

Not yet recruiting·—·Phase 3·NCT07252544·3,156 enrolled

Left Ventricular Hypertrophy1 trial

Effect of Isosorbide Mononitrate on Hypertension to Improve Left Ventricular Hypertrophy, Fibrosis and Myocardial Function

Withdrawn·—·Phase 2·NCT01961453

Coronary Artery Disease1 trial

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

Completed· Bayer logo

Bayer·Phase 1·NCT03255512·41 enrolled

Induction of Labour1 trial

Isosorbide Mononitrate in Induction of Labour

Unknown status·—·Phase 1·NCT04482881·130 enrolled

Homeostasis1 trial

Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00871871·64 enrolled

Safety and Efficacy1 trial

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

Unknown status·—·Phase 3·NCT04311658·88 enrolled

Coronary Artery Bypass Graft1 trial

Effect of Nicorandil, Diltiazem or Isosorbide Mononitrate for Oral Antispastic Therapy After Coronary Artery Bypass Grafting Using Radial Artery Grafts - A Pilot Randomized Controlled Trial

Completed·RRuijin Hospital·Approved·NCT04310995·150 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ISMOTIC

NDA NDA017063

Dec 30, 1991

ISMO

NDA NDA019091

Jun 30, 1993

MONOKET

NDA NDA020215

Aug 12, 1993

IMDUR

NDA NDA020225

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Isosorbide mononitrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Imdur drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Isosorbide mononitrate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Isosorbide mononitrate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020225). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Omnivium 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: OOmnivium

Imdur

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2028

Q1 2030

Trials by Indication[1]

Induction of Labor3 trials

Trial2 trials

Headache2 trials

Intestinal Cancer1 trial

Anal fissure1 trial

Pregnancy1 trial

Prophylaxis1 trial

Cesarean Section1 trial

Oligohydramnios1 trial

Heart Failure1 trial

Pain1 trial

Randomized Controlled Trial1 trial

Abortion1 trial

Kidney Injury1 trial

ART1 trial

Stroke1 trial

Left Ventricular Hypertrophy1 trial

Coronary Artery Disease1 trial

Induction of Labour1 trial

Homeostasis1 trial

Safety and Efficacy1 trial

Coronary Artery Bypass Graft1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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