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Adalvo begins Diroximel Fumarate dossier development to expand Multiple Sclerosis treatment options

Business
29 December 2025

Adalvo has commenced dossier development for Diroximel Fumarate (DRF), a next-generation treatment for Relapsing Remitting Multiple Sclerosis (MS).  

Diroximel Fumarate (DRF) is an orally administered prodrug of the active metabolite Monomethyl Fumarate (MMF). Based on EMA’s CHMP assessment, its efficacy is comparable to Dimethyl Fumarate (DMF). 

This strategic addition strengthens Adalvo's CNS portfolio and reinforces the company's promise to offer a full range of high-quality, differentiated MS therapies to patients worldwide. 

Multiple sclerosis is a chronic CNS disease affecting some 2.8 million people globally. Symptoms typically appear between 20 and 40 years of age and are characterised by relapsing and remitting episodes, and progressive neurological decline, which can significantly impact patients’ quality of life. 

According to IQVIA MAT Q2 2025, global DRF sales exceeded $1 billion, with a compound annual growth rate of 14%, highlighting a strong and growing market demand. 

Adalvo is pursuing an innovative development strategy targeting Day-1 market access

For licensing opportunities or to explore Adalvo's neurology portfolio, contact the team today