NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
IMDUR (isosorbide mononitrate) by Merck & Co. 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 1993.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMDUR is an extended-release oral tablet containing isosorbide mononitrate, a nitrate vasodilator used to prevent angina pectoris. It works by relaxing vascular smooth muscle to dilate peripheral arteries and veins, reducing cardiac preload and afterload while improving coronary blood flow. The drug is indicated for patients with chronic stable angina requiring regular prophylactic therapy.
LOE Approaching
Product approaching loss of exclusivity with modest competitive pressure (30) and limited linked job openings suggests a mature franchise in defensive posture.
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 (5)
Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial
Started Jan 2024
Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects
Started Dec 2020
0PharmacokineticsHealthy Subjects
Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury
Started Sep 2019
9 enrolled
Kidney InjuryProteinuriaHypertension
PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure
Started Jul 2017
0Anal Fissure
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)
Started Mar 2009
64 enrolled
Hypertension
Worked on IMDUR at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
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.