Trospium

Syndeio Biosciences launched with $90 million in funding to develop the first synapse-targeted therapeutics for neurological and psychiatric disorders affecting over one billion people globally.

The Alzheimer's drug development landscape has expanded significantly beyond anti-amyloid antibodies, with 88 different clinical trials currently recruiting patients and twelve Phase 3 trials expected to report results in 2025.

Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) did not achieve statistical significance as an adjunctive therapy for schizophrenia in the Phase 3 ARISE trial, showing only a 2.0-point reduction in PANSS scores compared to placebo.

• Sumitomo Pharma America's ulotaront (SEP-363856), a novel TAAR1 and 5-HT1A agonist, failed to demonstrate statistical significance versus placebo in two Phase 3 trials for acute schizophrenia. • Despite showing favorable safety profile with fewer metabolic side effects compared to current antipsychotics, the drug's efficacy was masked by an unexpectedly high placebo response in the DIAMOND 1 and 2 studies. • The setback occurs amid ongoing development of other promising schizophrenia treatments, including Karuna's KarXT and Minerva's roluperidone, which are advancing toward potential market approval.

• China's NMPA has accepted Zai Lab's NDA for KarXT for treating schizophrenia in adults, addressing a significant unmet need. • Phase 3 trials in China showed KarXT significantly reduced schizophrenia symptoms compared to placebo, with a tolerable safety profile. • KarXT represents a novel class of treatment targeting muscarinic acetylcholine receptors, offering a new approach compared to traditional antipsychotics. • The NDA is supported by Phase 1 and Phase 3 China studies, along with data from global EMERGENT clinical programs, indicating robust evidence.