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Monoket (ISOSORBIDE MONONITRATE)
Monoket (Isosorbide Mononitrate) is a nitrate vasodilator medication that targets the atrial natriuretic peptide receptor 1. It is a small molecule modality that was originally developed and is currently owned by Schering Plough. Monoket is FDA-approved for the prevention and treatment of angina pectoris, and it has been off-patent since its approval in 1991. The medication has a bioavailability of 93% and a half-life of 4.1 hours. Monoket is available from 18 generic manufacturers.
At a glance
| Generic name | ISOSORBIDE MONONITRATE |
|---|---|
| Sponsor | Schering Plough |
| Drug class | Nitrate Vasodilator [EPC] |
| Target | Atrial natriuretic peptide receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Angina Pectoris Prevention
- Angina pectoris
Common side effects
- Headache
- Dizziness
- Fatigue
- Nausea
- Diarrhea
- Abdominal pain
- Constipation
- Dyspepsia
- Flatulence
- Gastritis
- Glossitis
- Hemorrhoids
Drug interactions
- sildenafil
Key clinical trials
- Baroreflex Activation Therapy for Heart Failure (NA)
- Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy (PHASE1,PHASE2)
- DANHEART (H-HeFT and Met-HeFT) (PHASE4)
- Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies (PHASE3)
- Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT) (PHASE3)
- Treatment of Orthostatic Intolerance (PHASE1,PHASE2)
- Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After CABG (PHASE4)
- Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Monoket CI brief — competitive landscape report
- Monoket updates RSS · CI watch RSS