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Direclidine
Antipsychotic drug From Wikipedia, the free encyclopedia
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Direclidine (INN;[2] developmental code names NBI-1117568, HTL-0016878)[1] is an investigational antipsychotic drug for schizophrenia[3] that was out-licensed Nexera Pharma in to Neurocrine Biosciences, a United States-based pharmaceutical company.[4][1][5] It is administered orally.[6][7]
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Overview
It is a selective muscarinic acetylcholine M4 receptor agonist that indirectly modulates dopamine as the basis for its putative improvement of schizophrenia.[6] In April 2016, the compound was out-licensed to Allergan, an Irish pharmaceutical company. By September 2017, it had advanced to Phase I clinical trial for the indication of "neuropsychiatric symptoms associated with Alzheimer's disease and other dementias"[8] However, in May 2020, Allergan was acquired by AbbVie, and due to AbbVie's pipeline business decisions, the license was returned to Nexceris in January 2021.[9] In November 2021, the compound was newly out-licensed to Neurocrine Biosciences, a U.S. pharmaceutical company.[5] It has been under development as a treatment for schizophrenia, and as of September 2024, Phase II clinical trials have been completed.[10][11]
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History
- 2016
- April: The rights to develop and sell NBI-1117568 were transferred from its original developer to Allergan.[9]
- 2017
- September: Allergan initiated Phase I clinical trials for NBI-1117568 to treat "neurobehavioral symptoms related to Alzheimer's disease and other conditions."[8]
- 2021
- 2022
- October: Phase II clinical trials began for NBI-1117568 to treat schizophrenia.[12]
- 2024
- 2025
- May:Nexera Pharma announced the initiation of a Phase III clinical trial for NBI-1117568.[14]
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Clinical trials
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Phase II clinical trial
The Phase II clinical trial was conducted in 15 sites across the U.S. with 200 adult patients diagnosed with schizophrenia.[15] The primary endpoint was assessed by the change in the total score of the Positive and Negative Syndrome Scale (PANSS) after six weeks of treatment. The 20 mg once-daily group showed a statistically significant improvement of 7.5 points compared to the placebo group (improvement of 18.2 points from baseline, p = 0.011, effect size = 0.61).[16] However, the 40 mg once-daily group, 60 mg once-daily group, and 30 mg twice-daily group did not show statistically significant differences compared to the placebo group (p-values: 40 mg group: 0.282, 60 mg group: 0.189, 30 mg twice-daily group: 0.090).[16]
Market reaction to phase II clinical trial
With a PANSS improvement of 7.5, NBI-111758 lagged behind xanomeline/trospium (KarXT) (Karuna Therapeutics) with 8.4 and emraclidine (Cerevel Therapeutics) with 12.7, both of which were in clinical trials at the same time. Moreover, the lack of dose-dependency led to disappointment in the stock market.[17] Neurocrine Biosciences' share price dropped 19% on the day following the announcement of the Phase II clinical trial results.[18]
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References
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