It has an anti-inflammatory and neuroprotective effect on the brain. It has been granted orphan drug designation* for the treatment of ALS by the European EMA, and the American FDA.
A bile salt that is found naturally occurring in the body. It has been granted orphan designation* by the European Medicines Authority (EMA) for the treatment of ALS.
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✢ Generic drugs are medicines created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. A generic medicine works in the same way and provides the same clinical benefit as its brand-name version.
* Orphan drugs are medicines targeting conditions which are so rare that they are unlikely to generate sufficient profit to justify research and development costs. Each regulatory agency (e.g. the FDA or EMA) has an independent process for assigning orphan drug status. Sponsors of these medicines receive incentives from the agencies to support and facilitate the development and authorisation of these therapeutics.