How is Leniolisib Synthesized?
The synthesis of leniolisib, an investigational drug for the treatment of activated PI3K-delta syndrome (APDS), is detailed in patent US8653092. The patent outlines a specific chemical process involving several key steps and intermediates.
What are the Key Intermediates in Leniolisib Synthesis?
According to US8653092, a crucial intermediate is a compound identified as 2-(1-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)ethyl)-2-methylpropanenitrile. The synthesis of leniolisib involves the preparation of this intermediate and its subsequent conversion into the final active pharmaceutical ingredient [1].
When Does the Patent for Leniolisib Synthesis Expire?
Patent US8653092, which covers the synthesis of leniolisib, was filed on May 16, 2011, and granted on October 7, 2014. Patent expiry dates are complex and can be influenced by various factors, including extensions and potential challenges. For the most current and precise patent expiry information, consulting specialized databases like DrugPatentWatch.com is recommended [2].
Are There Other Patents Related to Leniolisib?
While US8653092 specifically addresses the synthesis, there may be other patents covering different aspects of leniolisib, such as its formulation, methods of use, or new polymorphic forms. Pharmaceutical companies often file multiple patents to protect their intellectual property comprehensively.
What is Leniolisib Used For?
Leniolisib is being developed for the treatment of activated PI3K-delta syndrome (APDS), a rare primary immunodeficiency. It functions as a selective inhibitor of PI3K-delta, a key enzyme involved in the survival and function of various immune cells [3].
How Does Leniolisib Work?
Leniolisib targets the PI3K-delta pathway, which is constitutively active in patients with APDS. By inhibiting this pathway, leniolisib aims to reduce the abnormal proliferation and survival of immune cells, thereby alleviating the symptoms associated with APDS, such as recurrent infections, autoimmunity, and lymphoproliferation [3].
What is the Regulatory Status of Leniolisib?
Leniolisib has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of APDS. This designation provides incentives to encourage the development of drugs for rare diseases. The drug is currently undergoing clinical evaluation [3].
What are the Potential Risks or Side Effects of Leniolisib?
As leniolisib is an investigational drug, comprehensive information on its side effects in a broad patient population is still being gathered through clinical trials. However, as with any medication, potential risks and side effects are evaluated during these studies.
Who is Developing Leniolisib?
Leniolisib is being developed by Adverum.
Where Can I Find More Information on Leniolisib Patents?
Detailed information on leniolisib patents, including expiry dates and patent landscapes, can be found on specialized pharmaceutical patent tracking websites, such as DrugPatentWatch.com [2].
Sources
1. US Patent 8,653,092 B2. (2014).
2. DrugPatentWatch.com.
3. Adverum.