(Olanzapine + samidorphan l-malate) is under clinical development by Alkermes and currently in Phase III for Bipolar I Disorder. According to GlobalData, Phase III drugs for Bipolar I Disorder have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how (Olanzapine + samidorphan l-malate)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
(Olanzapine + samidorphan l-malate) overview
Olanzapine and Samidorphan L-malate (Lybalvi) is a fixed dose combination, under development for the treatment of pediatric schizophrenia and bipolar I disorder. Samidorphan acts by targeting Mu opioid. Olanzapine targets 5-HT2A and D2 dopamine receptors. The drug is developed based on opioid modulator platform.
Alkermes overview
Alkermes is a biopharmaceutical company that focuses on the research, development, and commercialization of drugs for the treatment of cancer, neurodegenerative and central nervous system (CNS) diseases. The company’s proprietary products include Aristada and Aristada Initio an extended-release intramuscular injectable suspension for the treatment of schizophrenia; and Vivitrol, a once-monthly, non-addictive, injectable medication for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence. It grants licenses under its proprietary technologies to enable third parties to develop, commercialize, and manufacture products. Alkermes sells its products primarily to pharmaceutical wholesalers, treatment providers, specialty distributors and pharmacies. The company has global operations. Alkermes is headquartered in Dublin, Ireland.
For a complete picture of (Olanzapine + samidorphan l-malate)’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
