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Find Psychiatry/Psychology Drugs in Phase III Clinical Development

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            Lead Product(s): Dexmedetomidine

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 19, 2020

            Details:

            More than one-third of the SERENITY I & II patients have been dosed, including over 100 bipolar patients.

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            Lead Product(s): SAGE-217

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 18, 2020

            Details:

            Expected regulatory pathway for episodic treatment of major depression remains unchanged with plan for one new additional efficacy study.

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            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 17, 2020

            Details:

            Company is modifying its pivotal Phase 3 clinical trial of the Company's lead drug candidate, AD04, for the treatment of alcohol use disorder (AUD) in genetically targeted patients.

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            Lead Product(s): Olanzapine,Samidorphan

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 04, 2020

            Details:

            ENLIGHTEN-1 was a four-week study evaluating the efficacy, safety and tolerability of ALKS 3831 compared to placebo in 403 patients experiencing an acute exacerbation of schizophrenia.

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            Lead Product(s): SAGE-217

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 27, 2020

            Details:

            The company will be evaluating path forward for the zuranolone (SAGE-217) Landscape Program.

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            Lead Product(s): Lumateperone

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 20, 2020

            Details:

            In this trial, CAPLYTA 42 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4.

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            Lead Product(s): Naloxone

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 19, 2020

            Details:

            At the face to face meeting, the Company obtained concurrence from the agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA.

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            Lead Product(s): Dexmedetomidine

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 18, 2020

            Details:

            The Phase 2 study by researchers at Yale University is designed to measure biomarkers associated with agitation in patients with schizophrenia and the response to treatment with BXCL501.

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            Lead Product(s): Trigriluzole

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 10, 2020

            Details:

            In the study, patients receiving the experimental drug, troriluzole, twice everyday did not show improvement in anxiety symptoms, compared to a placebo.

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            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 06, 2020

            Details:

            The trial is designed to validate Adial's proprietary companion diagnostic genetic test, once validated in the trial, serve to identify patients for treatment in the commercial setting.

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