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Ulotaront Phase III Schizophrenia Setback For Sumitomo, Otsuka Alliance

'High Placebo Response'

 
• By Ian Haydock

Novel psychiatric drug has missed its Phase III efficacy endpoint in two Phase III trials, posing a potential blow to the Japanese firms' alliance plans in schizophrenia, although development in other CNS indications looks set to continue. 

Ulotaron's Phase III DIAMOND 1 and 2 studies missed the primary endpoints
ulotaront misses target in two Phase III trials • Source: Shutterstock

Sumitomo Pharma Co., Ltd. and Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) has failed in two Phase III trials for severe schizophrenia, posing a setback for the multi-product CNS alliance between the two Japanese firms in which it is one of the lead assets.

The DIAMOND 1 and 2 studies with the first-in-class, once-daily oral trace amine-associated receptor 1 (TAAR1) agonist were conducted in acutely psychotic adults living with

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