MONOKET (isosorbide mononitrate)
MONOKET is indicated for the treatment of Angina Pectoris; Coronary Artery Disease.
Details
- Status
- Prescription
- First Approved
- 1993-06-30
- Routes
- ORAL
- Dosage Forms
- TABLET
MONOKET Approval History
What MONOKET Treats
2 indicationsMONOKET is approved for 2 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Angina Pectoris
- Coronary Artery Disease
MONOKET Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MONOKET
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07456852 | MC250411 NCI-2026-01065, MC250411 | Ph 1, Ph 2 | not yet recruiting | Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy |
| NCT07252544 | 2023ZD0504802 | Ph 3 | not yet recruiting | Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT) |
| NCT03544606 | ISMN and labor induction | Ph 4 | completed | Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor |
| NCT02573051 | ANP | Ph 2 | withdrawn | Termination Of Anembryonic Pregnancy |
| NCT04051957 results posted | HSC-MS-19-0429 | Ph 2 | terminated | Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury |
| NCT04729088 | CAEP 56.003.19PC | Ph 1 | withdrawn | Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects |
| NCT04312048 | 00249 | Ph 3 | completed | the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion |
| NCT03665779 | AN1988 | Ph 3 | completed | Nitric Oxide Donor Isosorbide Mono Nitrate for Induction of Labor With Pre-labor Rupture of Membranes |
| NCT03407521 | R02 MH12345 | Ph 4 | completed | Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion |
| NCT02481323 Prevent-SVD | PrevSVD-2015 2015-001953-33, 252 (AS-PG-14-033) | Ph 2 | completed | Lacunar Intervention Trial 1 (LACI-1) |
| NCT02667535 | GDN 001/16 | Ph 1 | withdrawn | PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure |
| NCT02053493 NEAT-HFpeF results posted | Pro00050042 4U10HL084904-10 | Ph 2 | completed | Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction |
| NCT02712125 | Benha-023 | Ph 2, Ph 3 | completed | Nitric Oxide Donors for Treatment of Isolated Oligohydramnios |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MONOKET FDA Label Details
Indications & Usage
FDA Label (PDF)MONOKET is indicated for the treatment of Angina Pectoris; Coronary Artery Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.