Zydus Lifesciences announces WHO approval for NLRP3 inhibitor Usnoflast


Zydus Lifesciences, a discovery-based, global pharmaceutical leader, has recently received approval from the World Health Organization (WHO) International Non-proprietary Names (INN) for “Usnoflast” as the recommended name for ZYIL1, marking a significant milestone in the development of treatments for neuroinflammatory and autoinflammatory diseases. Usnoflast (ZYIL1) is an innovative oral small molecule NLRP3 inhibitor, showcasing high potency in human whole blood assays and the ability to suppress inflammation caused by the NLRP3 inflammasome.

The discovery and development of Usnoflast at Zydus highlight the company’s commitment to addressing complex health challenges through pioneering research. The compound has shown promising results in pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD), and Multiple Sclerosis (MS), demonstrating an acceptable ADME profile with a good safety margin. In Phase I studies, ZYIL1 was found to be safe and well-tolerated, laying the groundwork for further clinical investigation.

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Pankaj Patel, Chairman of Zydus Lifesciences, emphasized the significance of Usnoflast’s discovery, stating, “In keeping with our mission of creating healthier communities globally, we discovered the novel oral NLRP3 inhibitor ‘Usnoflast’ with potential to provide ‘Pipeline-in-a-pill’ treatment owing to the number of different patient populations NLRP3 mechanism can target.” The company is currently advancing clinical development in various indications, including rare autoinflammatory diseases and neurological conditions such as Amyotrophic Lateral Sclerosis (ALS), Parkinson’s Disease, and Ulcerative Colitis.

Zydus’s innovative approach has led to the establishment of Phase 2 proof-of-concept in Cryopyrin-associated periodic syndromes (CAPS) patients, with the US Food and Drug Administration (FDA) granting Orphan Drug Designation for Usnoflast to treat CAPS. Furthermore, Usnoflast is under Phase 2 clinical trial for ALS, highlighting its potential impact on a disease affecting thousands annually in the U.S. alone. Additional studies are exploring its efficacy in treating Ulcerative Colitis and Parkinson’s disease, diseases with significant global prevalence and growing demand for effective treatments.

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The approval of Usnoflast’s name by WHO’s INN system underscores the importance of providing healthcare professionals worldwide with a universal and unique name for each pharmaceutical substance, facilitating clear communication and ensuring patient safety across borders.

The WHO’s approval of Usnoflast as the INN for ZYIL1 is a testament to the work being done by Zydus Lifesciences in the field of pharmaceutical research. This development not only represents a significant achievement for Zydus but also highlights the global pharmaceutical industry’s ongoing commitment to discovering and developing new treatments for complex diseases. The potential of Usnoflast to provide effective treatment options for multiple patient populations speaks to the innovative spirit of Zydus and its dedication to improving global health outcomes.

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In conclusion, the WHO’s recognition of Usnoflast sets a new standard in the treatment of neuroinflammatory and autoinflammatory diseases, reflecting the pharmaceutical industry’s continuous efforts to enhance patient care through innovation. As Zydus moves forward with clinical trials and further development, the global healthcare community watches with anticipation, hopeful for the positive impact Usnoflast may bring to patients worldwide.

Zydus Lifesciences’ achievement in receiving WHO approval for Usnoflast marks a significant milestone in pharmaceutical innovation, offering new hope for patients suffering from neuroinflammatory and autoinflammatory diseases. As clinical trials progress, the potential of Usnoflast to revolutionize treatment paradigms holds great promise, underscoring the importance of continued investment in research and development within the global healthcare sector.

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