NDAORALTABLET
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
ISMO (isosorbide mononitrate) by Alkermes is mechanism of action isosorbide mononitrate extended-release tablet are an oral extended-release formulation of ismn, the major active metabolite of isosorbide dinitrate; most of the clinical activity of the dinitrate is attributable to the mononitrate. First approved in 1991.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISMO is an oral extended-release formulation of isosorbide mononitrate, a nitrate vasodilator used to prevent angina pectoris. It works by relaxing vascular smooth muscle, dilating peripheral arteries and veins, reducing cardiac preload and afterload while improving coronary blood flow. The product is indicated for angina prophylaxis in patients with coronary artery disease.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely transitioning to generic defense and niche market strategies.
Mechanism of Action
Mechanism of Action Isosorbide mononitrate extended-release tablet are an oral extended-release formulation of ISMN, the major active metabolite of isosorbide dinitrate; most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of ISMN…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Impact of Supplementation in Improving Metabolic Health Outcomes (ISMOS) Study
Started Jan 2026
400 enrolled
Glucose ControlMental HealthMusculoskeletal Health+1 more
Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Started Dec 2024
24 enrolled
Metastatic Lung Non-Small Cell CarcinomaRecurrent Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8
Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Started Jul 2024
40 enrolled
Regional Citrate Anticoagulation (RCA)Continuous Renal Replacement Therapy (CRRT)Acute Kidney Injury (AKI)
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
Started Apr 2024
80 enrolled
Basal Cell Carcinoma
Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial
Started Jan 2024
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.