MN-001 (Tipelukast) - (NATG-202)

Sept. 28, 2026: MediciNova (NASDAQ: MNOV; Tokyo: 4875) reported topline results from the Phase 2 MN-001-NATG-202 trial of MN-001 (tipelukast) in 40 patients with hypertriglyceridemia and nonalcoholic fatty liver disease associated with type 2 diabetes. In the 24-week randomized, double-blind, placebo-controlled study, triglycerides fell 45.8 mg/dL (21.78%) with MN-001 vs 14.4 mg/dL (6.97%) with placebo at Week 24, a nonsignificant difference (p=0.113), while the Week 4 triglyceride reduction was statistically significant: 54.7 mg/dL vs 23.8 mg/dL (p=0.015). HDL-C increased 3.3 mg/dL with MN-001 and fell 2.4 mg/dL with placebo (difference 5.7 mg/dL; p=0.0048), and HDL particle concentration increased 3.62 µmol/L vs a 0.9 µmol/L decrease with placebo (difference 4.52 µmol/L; p=0.018). Liver fat by FibroScan CAP and body weight showed numerical but nonsignificant improvement versus placebo (p=0.2438 and p=0.082, respectively). MN-001 was generally safe and well tolerated, with mild to moderate treatment-related adverse events and no drug-related serious adverse events. The company said the exploratory proof-of-concept results support evaluating efficacy in a larger study and it will assess next-stage development.