Policy & Regulation
Theravance Biopharma receives approval for velusetrag (TD-5108)
8 December 2016 -

It was reported on Wednesday that Theravance Biopharma, a biopharmaceutical company, has received approval for its velusetrag (TD-5108) from the US Food and Drug Administration.

The product is intended for the treatment of symptoms associated with idiopathic and diabetic gastroparesis. It is an oral investigational drug in development for the treatment of gastroparesis, and is presently being examined in a large, multinational Phase 2b study in patients with confirmed gastroparesis of either diabetic or idiopathic origin. It is being developed by Theravance Biopharma in collaboration with Alfa Wassermann.

According to the terms of the contract, Alfa Wassermann pays for the majority of the Phase 2 clinical costs and has an exclusive option to develop and commercialise velusetrag in the European Union, Russia, China, Mexico and certain other countries, while Theravance Biopharma retains full rights to velusetrag in the United States, Canada, Japan and certain other countries.

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