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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","year":"2020","type":"Not Applicable","leadProduct":"Olanzapine","moa":"5-HT2C receptor","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved","graph3":"Alkermes Plc","amount2":0,"therapeuticAreaNew":"Psychiatry\/Psychology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Psychiatry","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Alkermes Plc \/ Not 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molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Alkermes Plc \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Alkermes P.."},{"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":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","year":"2020","type":"Not Applicable","leadProduct":"Samidorphan L-Malate","moa":"Mu-opioid receptor","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III","graph3":"Alkermes Plc","amount2":0,"therapeuticAreaNew":"Psychiatry\/Psychology","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph 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Plc","amount2":0,"therapeuticAreaNew":"Psychiatry\/Psychology","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Psychiatry","productSubType":"","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Alkermes Plc \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Alkermes P.."},{"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":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","year":"2020","type":"Not Applicable","leadProduct":"Samidorphan L-Malate","moa":"Mu-opioid receptor","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase 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2021","year":"2021","type":"Not Applicable","leadProduct":"Olanzapine","moa":"Mu-opioid receptor","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved","graph3":"Alkermes Plc","amount2":0,"therapeuticAreaNew":"Psychiatry\/Psychology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Psychiatry","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Alkermes Plc \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Alkermes P.."},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"April 2022","year":"2022","type":"Not Applicable","leadProduct":"Olanzapine","moa":"Mu-opioid receptor","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved","graph3":"Alkermes Plc","amount2":0,"therapeuticAreaNew":"Psychiatry\/Psychology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Psychiatry","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Alkermes Plc \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Alkermes P.."},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"January 2024","year":"2024","type":"Not Applicable","leadProduct":"Olanzapine","moa":"","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved","graph3":"Alkermes Plc","amount2":0,"therapeuticAreaNew":"Psychiatry\/Psychology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Psychiatry","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Alkermes Plc \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Alkermes P.."}]

    Find Clinical Drug Pipeline Developments & Deals for CCDC 710249, HCl salt

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                            01

                            Alkermes Plc

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                            26th North American ISSX
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                            Alkermes Plc

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                            26th North American ISSX
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                            Lead Product(s) : Olanzapine,Samidorphan L-Malate

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Approved

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Alkermes Announces Topline Results From Long-Term, Open-Label Safety and Durability of Treatment E...

                            Details : 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 d...

                            Product Name : Lybalvi

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            January 03, 2024

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Approved

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            02

                            Alkermes Plc

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                            26th North American ISSX
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                            Alkermes Plc

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                            26th North American ISSX
                            Not Confirmed
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                            Lead Product(s) : Olanzapine,Samidorphan L-Malate

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Approved

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Alkermes Presents New Data From Psychiatry Portfolio at 2022 Congress of the Schizophrenia Interna...

                            Details : 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.

                            Product Name : Lybalvi

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            April 07, 2022

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Approved

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            Alkermes Plc

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                            26th North American ISSX
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                            Alkermes Plc

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                            26th North American ISSX
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                            Lead Product(s) : Olanzapine,Samidorphan L-Malate

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Approved

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Alkermes Announces FDA Approval of LYBALVI™ for the Treatment of Schizophrenia and Bipolar Disor...

                            Details : In the ENLIGHTEN clinical development program, LYBALVI demonstrated antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain than olanzapine in patients with...

                            Product Name : Lybalvi

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            June 01, 2021

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Approved

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            Alkermes Plc

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                            26th North American ISSX
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                            Alkermes Plc

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                            26th North American ISSX
                            Not Confirmed
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                            Lead Product(s) : Olanzapine,Samidorphan L-Malate

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Alkermes to Showcase Data From Psychiatry Portfolio at Upcoming Scientific Conferences Throughout ...

                            Details : Highlights of the presentations include: A clinical overview of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831, consisting of 18 clinical studies, evaluating LYBALVI's antipsychoti...

                            Product Name : Lybalvi

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            May 03, 2021

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            Alkermes Plc

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                            26th North American ISSX
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                            Alkermes Plc

                            Ireland arrow
                            26th North American ISSX
                            Not Confirmed
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                            Lead Product(s) : Olanzapine,Samidorphan L-Malate

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Alkermes Presents New Data From Psychiatry Portfolio at Virtual 2021 Congress of the Schizophrenia...

                            Details : The company's presentations included new exploratory analyses from the phase 3 ENLIGHTEN-2 study of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831.

                            Product Name : Lybalvi

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            April 20, 2021

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            Alkermes Plc

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                            26th North American ISSX
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                            26th North American ISSX
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                            Lead Product(s) : Samidorphan L-Malate,Olanzapine

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831

                            Details : U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophre...

                            Product Name : ALKS 3831

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            December 29, 2020

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Alkermes Plc

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                            26th North American ISSX
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                            Lead Product(s) : Samidorphan L-Malate,Olanzapine

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review

                            Details : The AdCom will likely question whether or not ALKS-3831, a formulation of samidorphan and generically available olanzapine, provided a clinically meaningful reduction in the common weight gain side effect...

                            Product Name : ALKS 3831

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            November 17, 2020

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            08

                            Alkermes Plc

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                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipola...

                            Details : The committees voted 16-1 that samidorphan meaningfully mitigates olanzapine-associated weight gain and also ruled that the safety profile of the drug has been adequately characterised by 13-3.

                            Product Name : ALKS 3831

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            October 09, 2020

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            Alkermes Plc

                            Ireland arrow
                            26th North American ISSX
                            Not Confirmed

                            Alkermes Plc

                            Ireland arrow
                            26th North American ISSX
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
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                            Lead Product(s) : Samidorphan L-Malate,Olanzapine

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            Alkermes Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on ALKS 3831

                            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.

                            Product Name : ALKS 3831

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            October 07, 2020

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            10

                            Alkermes Plc

                            Ireland arrow
                            26th North American ISSX
                            Not Confirmed

                            Alkermes Plc

                            Ireland arrow
                            26th North American ISSX
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            Alkermes Presents New Psychiatry Data at Psych Congress 2020 Virtual Experience

                            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...

                            Product Name : ALKS 3831

                            Product Type : Small molecule

                            Upfront Cash : Not Applicable

                            September 14, 2020

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

                            Therapeutic Area : Psychiatry/Psychology

                            Highest Development Status : Phase III

                            Partner/Sponsor/Collaborator : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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