(Olanzapine + samidorphan l-malate) is a Small Molecule owned by Alkermes, and is involved in 23 clinical trials, of which 18 were completed, and 5 are ongoing.

Olanzapine antipsychotic activity is likely due to a combination of antagonism at D2 receptors in the mesolimbic pathway and 5HT2A receptors in the frontal cortex. Antagonism at D2 receptors relieves positive symptoms while antagonism at 5HT2A receptors relieves negative symptoms of schizophrenia. Samidorphan targets Mu opioid receptor and antagonize its activity. The opioid receptor pathways play a key role in a broad range of nervous system disorders.

The revenue for (Olanzapine + samidorphan l-malate) is expected to reach a total of $9.5bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the (Olanzapine + samidorphan l-malate) NPV Report.

(Olanzapine + samidorphan l-malate) is currently owned by Alkermes.

(Olanzapine + samidorphan l-malate) Overview

Olanzapine and Samidorphan L-malate (Lybalvi) is a fixed dose combination, in which olanzapine is an atypical anti-psychotic agent and samidorphan l-malate is an opioid antagonist. It is formulated as tablets for oral route of administration. Lybalvi is indicated for the treatment of schizophrenia in adults and Bipolar I disorder in adults in acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate and maintenance monotherapy treatment.

ALKS 3831 is under development for the treatment of schizophrenia, schizophreniform disorder and bipolar disorder. It is a fixed dose combination of samidorphan (ALKS 33) and olanzapine. The drug candidate is administered through oral route as bilayer tablet in once a day. 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 also 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.

The company reported revenues of (US Dollars) US$1,173.8 million for the fiscal year ended December 2021 (FY2021), an increase of 13% over FY2020. The operating loss of the company was US$32.3 million in FY2021, compared to an operating loss of US$112.4 million in FY2020. The net loss of the company was US$48.2 million in FY2021, compared to a net loss of US$110.9 million in FY2020. The company reported revenues of US$252.4 million for the third quarter ended September 2022, a decrease of 8.6% over the previous quarter.

Quick View – (Olanzapine + samidorphan l-malate)

Report Segments
  • Innovator (NME)
Drug Name
  • (Olanzapine + samidorphan l-malate)
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.