Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
April 20, 2021
Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
March 05, 2021
Lead Product(s) : Olanzapine,Samidorphan
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : BP-101
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
First Patient Enrolled in Ovoca Bio's Phase II Study - BP-101
Details : The double-blind placebo-controlled study is expected to enrol 476 patients across 13 sites. BP-101 is a synthetic peptide administered through a nasal spray and has been supplied for this study by well established peptide manufacturers in Switzerland an...
Product Name : BP-101
Product Type : Antibody
Upfront Cash : Inapplicable
January 29, 2021
Lead Product(s) : BP-101
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan,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,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan,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,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan,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,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan,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,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan,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,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan,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,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Samidorphan,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,Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable