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[{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Journal of Clinical Psychiatry Publishes Data from Alkermes' Phase 3 ENLIGHTEN-1 Efficacy Study","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Data From Schizophrenia Portfolio at Virtual 2020 Congress of the Schizophrenia International Research Society","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Impel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Impel NeuroPharma Announces Publication of Positive Results of SNAP 101 Study for INP105","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Indoco Remedies Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Indoco Remedies Gets USFDA Nod for Schizophrenia, Bipolar Disorder Treatment Drug","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"American Journal of Psychiatry Publishes Data From Alkermes' Phase 3 ENLIGHTEN-2 Weight Study of ALKS 3831 in Patients With Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Virtual FDA Advisory Committee Meeting to Review Alkermes' New Drug Application for ALKS 3831 in Schizophrenia and Bipolar I Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Psychiatry Data at Psych Congress 2020 Virtual Experience","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on ALKS 3831","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Starton Therapeutics","sponsor":"Haisco Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Starton Therapeutics and Haisco Pharmaceutical Ink Licensing Agreement to Develop & Commercialize STAR-OLZ for Nausea and Vomiting in China","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase I"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Data From Psychiatry Portfolio at Virtual 2021 Congress of the Schizophrenia International Research Society","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes to Showcase Data From Psychiatry Portfolio at Upcoming Scientific Conferences Throughout Mental Health Awareness Month","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces FDA Approval of LYBALVI\u2122 for the Treatment of Schizophrenia and Bipolar Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Starton Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Starton Therapeutics Phase 2 TROPIC-I Clinical Study will be First to Use Total Control Primary Endpoint in Superiority Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"MedinCell","sponsor":"Teva Pharmaceutical Industries","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Phase 3 Study to Be Initiated for Second Long-acting Injectable Antipsychotic Using Medincell\u2019s Technology","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Cheplapharm Arzneimittel Gmbh","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$825.9 million","upfrontCash":"Undisclosed","newsHeadline":"Cheplapharm Places Notes in A Volume of \u20ac750m in Challenging Market Environment","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Starton Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Starton Therapeutics Announces FDA Clearance of IND Application for STAR-OLZ TDS for the Treatment of CINV","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Presents New Data From Psychiatry Portfolio at 2022 Congress of the Schizophrenia International Research Society","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Teva Pharmaceutical Industries","sponsor":"Royalty Pharma","pharmaFlowCategory":"D","amount":"$125.0 million","upfrontCash":"Undisclosed","newsHeadline":"Teva and Royalty Pharma Collaborate to Further Accelerate Olanzapine LAI Program","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Teva Pharmaceutical Industries","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"$1,500.0 million","upfrontCash":"$500.0 million","newsHeadline":"Teva Completes Closing of Exclusive Collaboration Deal to Deliver Inflammatory Bowel Disease Treatment","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Impel Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Impel Pharmaceuticals Announces First Patient Dosed in Phase 2a Study Evaluating INP105 to Treat Acute Agitation in Adolescents With Autism Spectrum Disorder (ASD)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"MedinCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Initiation Of the Phase 3 Study for The Second Long-Acting Injectable Antipsychotic Using Medin Cell\u2019s Technology (Program mdc-TJK)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zydus receives final approval from the USFDA for Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alkermes Announces Topline Results From Long-Term, Open-Label Safety and Durability of Treatment Effect Study of LYBALVI\u00ae (olanzapine and samidorphan)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"MedinCell","sponsor":"Teva Pharmaceutical Industries","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MedinCell\u2019s Partner Teva Announces Recruitment Completion of Phase 3 Clinical Study of mdc-TJK \/ Olanzapine Long-Acting Injectable (LAI)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"}]

Find Clinical Drug Pipeline Developments & Deals for DSSTox_CID_3388

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            TEV-44749 (olanzapine) is a novel D2/5-HT2 receptor inhibitor which is under phase 3 clinical development for the treatment of patients with Schizophrenia.

            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: TEV-44749

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 09, 2024

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            Lybalvi (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug. It is approved by USFDA for treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder.

            Lead Product(s): Olanzapine,Samidorphan L-Malate

            Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 03, 2024

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            The collaboration aims to co-develop and co-commercialize asset TEV’574, a novel anti-TL1A therapy, currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn's Disease, two types of inflammatory bowel disease.

            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: TEV-‘749

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: $1,500.0 million Upfront Cash: $500.0 million

            Deal Type: Collaboration November 30, 2023

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            The collaboration aims to accelerate the clinical research program for Teva’s TEV-‘749 (olanzapine), a once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine that is currently in Phase 3 for the treatment of schizophrenia.

            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: TEV-‘749

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Royalty Pharma

            Deal Size: $125.0 million Upfront Cash: Undisclosed

            Deal Type: Collaboration November 13, 2023

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            The proceeds from the new bonds will be used to finance the acquisition of the worldwide commercial rights for Zyprexa (olanzapine), an antipsychotic medication, from Eli Lilly and Company.

            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: Zyprexa

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $825.9 million Upfront Cash: Undisclosed

            Deal Type: Private Placement April 28, 2023

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            Olanzapine is an atypical antipsychotic that exerts its action primarily on dopamine and serotonin receptors. It works on dopamine D2 receptors in the mesolimbic pathway as an antagonist, blocking dopamine from potential action at the post-synaptic receptor.

            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: Olanzapine-Generic

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 11, 2023

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            mdc-TJK (olanzapine) is a thienobenzodiazepine classified as an atypical or second-generation antipsychotic agent. It works on dopamine D2 receptors in the mesolimbic pathway as an antagonist, blocking dopamine from potential action at the post-synaptic receptor.

            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: TV-44749

            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 January 24, 2023

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            The Phase 3 study will assess the efficacy and safety of potentially the first subcutaneous long-acting Injectable (LAI) formulation of mdc-TJK (olanzapine) for the treatment of patients with schizophrenia.

            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: mdc-TJK

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration August 29, 2022

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            INP105 (olanzapine) is being developed as an acute treatment for agitation in persons with autism spectrum disorder (ASD) using Impel’s proprietary Precision Olfactory Delivery (POD®) technology which delivers drugs to the upper nasal space.

            Lead Product(s): Olanzapine

            Therapeutic Area: Neurology Product Name: INP105

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 19, 2022

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            LYBALVI (olanzapine and samidorphan), an atypical antipsychotic drug approved in U.S. for treatment of adults with schizophrenia and for treatment of adults with bipolar I disorder.

            Lead Product(s): Olanzapine,Samidorphan L-Malate

            Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 07, 2022

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