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最高研发阶段批准上市 |
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首次获批日期1995-01-20 |
A Randomized, Double-blind, Placebo-controlled, Cross-over Trial to Evaluate the Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis
Orally administered ME-015 (Suplatast Tosilate) has been available on the market as a prescription drug for allergy-related conditions in Japan since 1995 with a very good safety and tolerability profile.
There is preclinical and exploratory clinical evidence suggesting that ME-015 may be effective in treating cough caused by idiopathic pulmonary fibrosis (IPF-cough).
80% of patients with idiopathic pulmonary fibrosis (IPF) are affected by a devastating dry cough that is often not responsive to standard cough treatments and causes significant psychological and physiological suffering as well as reduced quality of life. As of July 2023, there is no approved treatment for the indication of IPF-cough. There is an enormous unmet clinical need for an effective, safe and well-tolerated oral treatment.
The COSMIC-IPF Phase 2 trial is the first clinical trial assessing ME-015 for the treatment of IPF-cough and aims to generate clinical proof-of-concept results regarding the safety and efficacy of ME-015 in this condition.
100 项与 Melius Pharma AB 相关的临床结果
0 项与 Melius Pharma AB 相关的专利(医药)
100 项与 Melius Pharma AB 相关的药物交易
100 项与 Melius Pharma AB 相关的转化医学