Find Psychiatry/Psychology Drugs in Phase III Clinical Development

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            Lead Product(s): Samidorphan,Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831

            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 September 14, 2020

            Details:

            The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder.

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            Lead Product(s): Amphetamine Sulfate

            Therapeutic Area: Psychiatry/Psychology Product Name: AR19

            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 September 10, 2020

            Details:

            The Phase 3 data being presented support Arbor’s New Drug Application (NDA) for AR19, which also includes data demonstrating that AR19 resists manipulation for nonmedical misuse and abuse by non-oral routes of administration.

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            Lead Product(s): Cytisinicline

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            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 September 10, 2020

            Details:

            Cytisinicline data will be featured in two presentations on Friday, September 18th, at the SRNT-E virtual conference. Both presentations evaluate positive findings from studies comparing cytisinicline to varenicline (Chantix®).

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            Lead Product(s): Lumateperone

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            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 September 09, 2020

            Details:

            Lumateperone 42 mg achieved statistically significant results in primary and key secondary endpoints in Study 402. Company expects to submit supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in late 2020 or early 2021.

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            Lead Product(s): Immune globulin, human - ifas

            Therapeutic Area: Psychiatry/Psychology Product Name: Panzyga

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            The primary objective of the trial is to evaluate if PANZYGA® is superior to placebo (0.9% w/v sodium chloride) for reducing the severity of symptoms associated with PANS in pediatric patients.

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            Lead Product(s): Samidorphan,Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831

            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 August 21, 2020

            Details:

            ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

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            Lead Product(s): Samidorphan,Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831

            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 August 17, 2020

            Details:

            ENLIGHTEN-2 is the second of two key studies included in the ALKS 3831 ENLIGHTEN clinical development program.

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            Lead Product(s): Dextromethorphan,Bupropion

            Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05

            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 August 10, 2020

            Details:

            Enrollment has been completed in the COMET (Clinical Outcomes with NMDA-based Depression Treatment) Phase 3 open-label, long-term safety trial to support the planned NDA filing of AXS-05 in MDD.

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            Lead Product(s): PH94B

            Therapeutic Area: Psychiatry/Psychology Product Name: PH94B

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Maxim Group LLC

            Deal Size: $12.5 million Upfront Cash: Undisclosed

            Deal Type: Public Offering August 05, 2020

            Details:

            VistaGen currently intends to use the net proceeds from the offering for the continued development of its CNS pipeline programs, general research and development, working capital and general corporate purposes.

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            Lead Product(s): PH94B

            Therapeutic Area: Psychiatry/Psychology Product Name: PH94B

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: EverInsight Therapeutics

            Deal Size: Undisclosed Upfront Cash: $5.0 million

            Deal Type: Licensing Agreement August 04, 2020

            Details:

            EverInsight is responsible for clinical development, regulatory submissions and commercialization of PH94B, VistaGen's rapid-onset neuroactive nasal spray, for acute treatment of anxiety in adults with social anxiety disorder, in Greater China South Korea and Southeast Asia.

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