MediciNova Announces Completion of Patient Enrollment in MN-001-NATG-202 Clinical Trial of MN-001 (Tipelukast)

Executive Summary

• MediciNova announced that patient enrollment is now closed for its Phase 2 trial (MN‑001‑NATG‑202) evaluating MN‑001 (tipelukast) in hypertriglyceridemia and NAFLD associated with Type 2 diabetes.
• The randomized, double‑blind, placebo‑controlled study will assess co‑primary endpoints of liver fat reduction (CAP score) and fasting triglyceride change after 24 weeks of treatment.
• Top‑line efficacy and safety data are expected in the summer of 2026.

Key Details

• Trial Design: Multi‑center, randomized 1:1, double‑blind, placebo‑controlled; 500 mg/day MN‑001 vs. placebo for 24 weeks.
• Endpoints:
• Co‑primary: (1) Change in liver fat content measured by CAP score at Week 24; (2) Change in fasting serum triglycerides at Week 24.
• Secondary: Safety/tolerability, lipid profile changes (HDL‑C, LDL‑C, total cholesterol).
• Enrollment Status: Patient recruitment is now closed; all planned participants have been enrolled.
• Data Timeline: Top‑line results anticipated in summer 2026.
• Mechanism of MN‑001: Oral small‑molecule with leukotriene receptor antagonism, PDE3/4 inhibition, 5‑LO inhibition; preclinical anti‑inflammatory and anti‑fibrotic activity.
• Related Programs: MN‑001 previously evaluated in Phase 2 IPF trial; ongoing NAFLD program continues alongside this study.

Notable Quotes

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