Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Olanzapine,Samidorphan L-Malate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
January 06, 2021
Lead Product(s) : Olanzapine,Samidorphan L-Malate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
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 : ALKS 3831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 29, 2020
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
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 : ALKS 3831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 17, 2020
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
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 : ALKS 3831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 14, 2020
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
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 : ALKS 3831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 10, 2020
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
August 21, 2020
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ENLIGHTEN-2 is the second of two key studies included in the ALKS 3831 ENLIGHTEN clinical development program.
Product Name : ALKS 3831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 17, 2020
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
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 : ALKS 3831
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 10, 2020
Lead Product(s) : Samidorphan L-Malate,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable