Drug intelligence / Profile preview

IS-5-MN T2

Development stage
Unknown
Lead developer
Qilu Pharmaceutical
Modality
Small Molecules
Administration
Oral
01

Overview

**IS-5-MN T2** is an internal study designation for an extended-release (ER) formulation of **isosorbide-5-mononitrate** (40 mg tablets) developed by **Qilu Pharmaceutical**. Isosorbide-5-mononitrate is an organic nitrate vasodilator that acts as a prodrug to release nitric oxide (NO). NO activates soluble guanylyl cyclase (sGC), increasing intracellular cyclic GMP (cGMP) levels and leading to the relaxation of vascular smooth muscle. This predominantly dilates veins and peripheral vessels, reducing cardiac preload and myocardial oxygen demand, making it effective for the prevention and treatment of angina pectoris. IS-5-MN T2 was evaluated in a completed Phase 1 randomized, open-label, 3-way crossover bioequivalence study (NCT03557580) comparing it and another test formulation (T1) against the reference product ISMO Retard under fed conditions in healthy Chinese subjects.

Other names
IS-5-MN Test Formulation 2IS5-MN Test Formulation 2IS 5-MN Test Formulation 2isosorbide mononitrate extended-release tablet (test formulation 2)isosorbide-5-mononitrate extended-release tablet (test formulation 2)
02

Targets

PKG (cGMP-dependent protein kinase I alpha)sGC (Soluble Guanylyl Cyclase)

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