

Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target

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Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Lybalvi
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 03, 2024
Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Miscellaneous
Upfront Cash : Inapplicable
April 07, 2022
Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Lybalvi
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 01, 2021
Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Lybalvi
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 03, 2021
Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Miscellaneous
Upfront Cash : Inapplicable
April 20, 2021
Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 29, 2020
Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 17, 2020
Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 09, 2020
Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 07, 2020
Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 14, 2020
Lead Product(s) : Samidorphan,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
