Wendelsheim, Rhineland-Palatinate, September 9, 2025
Emrusolmin for the treatment of MSA reaches the next
important milestone
MODAG GmbH and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted
Fast Track designation to the jointly developed drug candidate Emrusolmin (TEV-56286) for the treatment of multiple system atrophy (MSA). Emrusolmin had already received orphan drug designation in 2022 and is currently being clinically tested in a Phase 2 study.
Fast Track designation is a special FDA program reserved for drugs addressing a high unmet medical need and with the potential to change the course of serious diseases. It enables closer collaboration with the agency, accelerated development processes, and prioritized review to make new therapies available to patients as early as possible.
Emrusolmin is a small molecule that targets pathological alpha-synuclein oligomers, which play a key role in the development and progression of MSA. The current development thus ties in directly with the Phase 2 study launched in Oktober 2024 and confirms the strategic value of the partnership between MODAG and Teva.
„The Fast Track Designation underscores the high relevance of our research work and marks another significant milestone. It shows that our approach is considered particularly promising by health authorities. Together with Teva, we are doing everything we can to advance the development of Emrusolmin as quickly as possible and make a truly disease-modifying therapy available to people with MSA.“
– Dr. Torsten Matthias, Managing Director of MODAG GmbH
Living with MSA
Multiple system atrophy is a rare, rapidly progressive neurodegenerative disease that affects the central nervous system. Those affected suffer from Parkinson’s-like symptoms, ataxia, speech and balance disorders, and severe autonomic impairments. Diagnosis is often challenging, and life expectancy after diagnosis is 7–10 years on average. To date, there is no approved therapy that can slow or halt the progression of the disease-treatment remains purely symptomatic. Fast Track designation therefore emphasizes the urgency of making new approaches such as Emrusolmin available as quickly as possible.
About MODAG
MODAG, a privately held German biotech company, is focused on the research and development of therapeutics and diagnostics for neurodegenerative diseases. MODAG’s innovative approach offers a unique combination of early diagnosis and targeted disease-modifying therapies for severe neurological disorders. MODAG’s collaborations with the top-tier US and European research institutions, combined with its founders and management team’s interdisciplinary research and development expertise, provide ideal conditions for accelerated implementation of clinical applications. Built upon an extensive portfolio of patented active compounds, MODAG is developing new oligomer modulators for MSA, PD and other neurodegenerative diseases such as Alzheimer’s disease, intending to deliver novel, first-in-class drugs with the potential to halt disease progression.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
