Atai Life Sciences and its subsidiary Recognify Life Sciences announced that their experimental drug inidascamine failed to meet the primary endpoint for improving cognitive impairment in patients with schizophrenia in a Phase 2b clinical trial1235.
The trial included 242 patients with cognitive impairment associated with schizophrenia and was conducted across the US and Europe25.
Patients on inidascamine showed some numerical improvements in cognitive and functional tests compared with placebo, but the results were not statistically significant1235.
Consistent improvement was observed across multiple cognitive domains, such as processing speed and verbal learning, though these did not translate into statistically significant primary efficacy235.
The safety profile of inidascamine was favorable, with no reports of sedation, weight gain, or extrapyramidal symptoms, which are common side effects of schizophrenia treatments35.
Atai plans to shift focus away from inidascamine and prioritize its psychedelic pipeline targeting affective disorders, while continuing exploratory analyses to identify possible responder populations or mechanistic insights13.
News of the trial failure led to a significant decline in Atai's stock price, falling between 9% and 14% in trading following the announcement124.
Sources:
1. https://www.gurufocus.com/news/3007727/atai-life-sciences-atai-stock-plunge-on-trial-failure-news
2. https://www.tradingview.com/news/reuters.com,2025:newsml_L4N3TM1JP:0-atai-life-sciences-schizophrenia-drug-fails-to-meet-main-goal-in-trial/
3. https://www.biopharmadive.com/news/atai-recognify-trial-failure-cognition-schizophrenia-drug/754184/
4. https://www.tradingview.com/news/reuters.com,2025:newsml_L4N3TM1JH:0-atai-life-sciences-schizophrenia-drug-fails-to-meet-main-goal-in-mid-stage-trial/
5. https://www.stocktitan.net/news/ATAI/recognify-life-sciences-provides-update-on-phase-2b-trial-of-yc4zk62tc15h.html