MedPath

Tipelukast

Generic Name
Tipelukast
Drug Type
Small Molecule
Chemical Formula
C29H38O7S
CAS Number
125961-82-2
Unique Ingredient Identifier
08379P260O
Background

Tipelukast is under investigation for the treatment of IPF and Idiopathic pulmonary fibrosis.

Clinical Trials
Related News

First Patient Enrolled in NIH-Funded Expanded Access Program for MN-166 in Advanced ALS

• MediciNova has enrolled the first patient in an NIH-funded Expanded Access Program trial evaluating MN-166 (ibudilast) in approximately 200 ALS patients who are ineligible for the ongoing Phase 2/3 COMBAT-ALS trial. • The EAP trial, supported through the Act for ALS, aims to provide access to MN-166 for individuals with advanced stages of amyotrophic lateral sclerosis while evaluating the drug's safety and efficacy. • MN-166 is an oral small molecule that inhibits phosphodiesterase type-4 and inflammatory cytokines, holding Orphan Drug Designation and Fast Track status from the FDA for ALS treatment.

MediciNova's Ibudilast Shows Promise in ALS Trial: Interim Analysis Reveals Strong Correlations

• MediciNova's COMBAT-ALS Phase 2/3 trial of MN-166 (ibudilast) in ALS shows positive correlations between 6-month and 12-month data for key metrics. • The Data Safety Monitoring Board (DSMB) recommended the trial continue as planned, supporting the robustness of the study design. • Patient assignments are expected to be completed by June 2025, with trial results anticipated in 2026, offering hope for ALS treatment advancements. • MediciNova is supporting continued treatment through the FDA's Expanded Access Program, ensuring access to MN-166 for more ALS patients.

NASH Treatment Market to Reach Significant Growth by 2032, Driven by Emerging Therapies

• The non-alcoholic steatohepatitis (NASH) market is poised for substantial growth, projected to expand significantly by 2032 across the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. • This growth is fueled by the introduction of novel therapies targeting NASH, with several drugs in Phase II and Phase III clinical trials showing promise for improving treatment outcomes. • Key players such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, and Novo Nordisk are actively developing innovative treatments, contributing to a dynamic and competitive market landscape. • The increasing prevalence of NASH and the growing understanding of its pathophysiology are driving the demand for effective therapies, creating opportunities for pharmaceutical companies.

MediciNova's Ibudilast (MN-166) Shows Promise in ALS Treatment: Phase 2/3 Trial Update

• MediciNova presented an update on its Phase 2/3 COMBAT-ALS trial of MN-166 (ibudilast) for amyotrophic lateral sclerosis (ALS) at the 2024 Annual NEALS Meeting. • The presentation highlighted the study design, scientific rationale, objectives, inclusion criteria, and enrollment status of the ongoing trial as of October 18, 2024. • An NIH-funded Expanded Access Protocol (EAP) is underway to provide MN-166 (ibudilast) to ALS patients ineligible for the COMBAT-ALS trial, supported by a $22 million grant. • MN-166 (ibudilast) is a small molecule compound targeting PDE4 and inflammatory cytokines, with potential benefits for neurodegenerative diseases like ALS.

FDA Approves Rezdiffra (Resmetirom) as First Treatment for NASH with Liver Fibrosis

• The FDA has granted accelerated approval to Rezdiffra (resmetirom) for adults with noncirrhotic NASH and moderate to advanced liver fibrosis. • Rezdiffra, a THR-β agonist, is the first FDA-approved medication for NASH, also known as MASH, marking a significant milestone. • Approval was based on Phase 3 MAESTRO-NASH trial data, which demonstrated improved liver fibrosis and NASH resolution compared to placebo. • Madrigal plans to launch Rezdiffra in the U.S. in April, with a patient support program to aid access and affordability.
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