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    [{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"IRELAND","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Olanzapine","moa":"5-HT2C receptor","graph1":"Psychiatry\/Psychology","graph2":"Approved","graph3":"Alkermes Plc","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Alkermes Plc \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Alkermes Plc \/ Not Applicable"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"IRELAND","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Olanzapine","moa":"5-HT2C receptor","graph1":"Psychiatry\/Psychology","graph2":"Approved","graph3":"Alkermes 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Plc","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Alkermes Plc \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Alkermes Plc \/ Not Applicable"},{"orgOrder":0,"company":"Alkermes Plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Olanzapine","moa":"","graph1":"Psychiatry\/Psychology","graph2":"Approved","graph3":"Alkermes Plc","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Alkermes Plc \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Alkermes Plc \/ Not Applicable"}]

    Find Clinical Drug Pipeline Developments & Deals for Samidorphan L-Malate

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    Samidorphan L-Malate

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                            01

                            Alkermes Plc

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                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Approved

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Alkermes Announces Topline Safety Results for LYBALVI® in Long-Term Study

                            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 adults with bipolar I disorder.

                            Brand Name : Lybalvi

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            02

                            Alkermes Plc

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                            American Pharma Summit
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                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Approved

                            Sponsor : 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 International Resea...

                            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.

                            Brand Name : Lybalvi

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Approved

                            Sponsor : 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 Disorder

                            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 schizophrenia in the ENLIGHTEN-2 study.

                            Brand Name : Lybalvi

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Phase III

                            Sponsor : 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 Mental Healt...

                            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 antipsychotic efficacy and weight mitigation profile along wit...

                            Brand Name : Lybalvi

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            Alkermes Plc

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                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Phase III

                            Sponsor : 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 Internation...

                            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.

                            Brand Name : Lybalvi

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Phase III

                            Sponsor : 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 schizophrenia and adults with bipolar I disorder.

                            Brand Name : ALKS 3831

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Phase III

                            Sponsor : 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 versus olanzapine.

                            Brand Name : ALKS 3831

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            08

                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder

                            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.

                            Brand Name : ALKS 3831

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            09

                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            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.

                            Brand Name : ALKS 3831

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            Alkermes Plc

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

                            Therapeutic Area : Psychiatry/Psychology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            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 patients living with schizophrenia or bipolar I d...

                            Brand Name : ALKS 3831

                            Molecule 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

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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