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iso- 5 - mononitrate
iso- 5 - mononitrate is a Nitrate vasodilator Small molecule drug developed by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. It is currently FDA-approved for Angina pectoris (prophylaxis and acute relief), Coronary artery disease.
Isosorbide 5-mononitrate is a nitrate vasodilator that releases nitric oxide to relax vascular smooth muscle and improve blood flow.
Isosorbide mononitrate is being studied in clinical trials for conditions such as labor fast, IUD insertion complication, heart decompensation, coronary heart disease, and unstable angina. Specifically, it is being investigated as a potential treatment for labor induction, with one trial using a combination of isosorbide mononitrate and misoprostol for this purpose.
At a glance
| Generic name | iso- 5 - mononitrate |
|---|---|
| Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| Drug class | Nitrate vasodilator |
| Target | Soluble guanylate cyclase (via nitric oxide) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
The drug is metabolized to nitric oxide, which activates guanylate cyclase in vascular smooth muscle cells, increasing cGMP levels and causing vasodilation. This reduces preload and afterload on the heart, decreasing myocardial oxygen demand and improving coronary blood flow. It is used primarily for angina prophylaxis and symptom relief in coronary artery disease.
Approved indications
- Angina pectoris (prophylaxis and acute relief)
- Coronary artery disease
Common side effects
- Headache
- Dizziness
- Hypotension
- Tachycardia
- Nausea
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)
- Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation (NA)
- 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)
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 |
|---|---|
| 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:
- iso- 5 - mononitrate CI brief — competitive landscape report
- iso- 5 - mononitrate updates RSS · CI watch RSS
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. portfolio CI
Frequently asked questions about iso- 5 - mononitrate
What is iso- 5 - mononitrate?
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Related
- Drug class: All Nitrate vasodilator drugs
- Target: All drugs targeting Soluble guanylate cyclase (via nitric oxide)
- Manufacturer: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Angina pectoris (prophylaxis and acute relief)
- Indication: Drugs for Coronary artery disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing