ITI-1549 / J&J - LARVOL DELTA

Discovery and biochemical characterization of ITI-1549, a novel serotonin 5-HT2a agonist, non-hallucinogenic psychedelic, for the treatment of neuropsychiatric disorders (Neuroscience 2024) - "These data indicate that ITI-1549 can impact brain plasticity and possesses enduring effects that outlast initial drug exposure. Thus, ITI-1549 may be a safe, non-hallucinogenic psychedelic lacking the potential to induce hallucinations and cardiac pathologies but retaining the potential as an acute or chronic treatment of mood, anxiety, and other neuropsychiatric disorders."

CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry

Characterization of the anti-anxiety and antidepressant properties of ITI-1549, a novel serotonin 5-HT2a agonist, non-hallucinogenic psychedelic, for the treatment of neuropsychiatric disorders (Neuroscience 2024) - "In sum, these data show that ITI-1549 is capable of attenuating anxiety and anhedonic- and depression-like behavior in male and female rodent models while not being associated with risks for adversities possessed by hallucinogenic psychedelics. To the extent that these data translate to humans, ITI-1549 may be useful for the acute and chronic treatment of certain neuropsychiatric diseases."

CNS Disorders • Cognitive Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry

Intra-Cellular Therapies Reports Second Quarter 2024 Financial Results, Provides Corporate Update and Raises 2024 CAPLYTA Sales Guidance (GlobeNewswire) - "Net product sales of CAPLYTA were $161.3 million for the second quarter of 2024, compared to $110.1 million for the same period in 2023....CAPLYTA total prescriptions increased 36% in the second quarter of 2024, compared to the same period in 2023 and 10% in the second quarter of 2024, compared to the first quarter of 2024....We anticipate submitting an sNDA with the U.S. Food and Drug Administration (FDA) in the second half of 2024....Our lead product candidate in this program, ITI-1549, continues to advance through IND enabling studies and is expected to enter human testing in 2025."

Commercial • FDA filing • New trial • Sales • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Discovery and Characterization of ITI-1549, a Novel Serotonin 5-HT2a Agonist, Non-Hallucinogenic Psychedelic, for the Treatment of Neuropsychiatric Disorders (SOBP 2024) - "ITI-1549 binds with high affinity (Ki = 10.2 nM) to 5-HT2a receptors and acts as a biased partial agonist with a strong bias toward signaling through the β-arrestin pathway and not through Gq coupled signaling. Importantly, ITI-1549 is a 5-HT2b antagonist (Ki = 4.8 nM), and not a 5-HT2b agonist; therefore it should not cause cardiac valvular pathology. Unlike hallucinogenic drugs, ITI-1549 does not elicit head twitch behaviors in mice."

Late-breaking abstract • CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry