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Saniona moves depression drug closer to first-in-human trial

The Swedish-Danish research company Saniona has submitted an application to the FDA to begin testing its oral drug candidate in patients with major depressive disorder.
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The company has filed an IND application (Investigational New Drug Application) and hopes to initiate a Phase 1 trial before the end of the year, pending FDA clearance.

The study will evaluate the safety, tolerability and pharmacokinetics of SAN2465 in healthy volunteers. It will also include validated cognitive tests and established pharmacodynamic measures, facilitating the definition of the dose range for future clinical studies in patients.

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