Sun Pharmaceutical Industries Limited ((IN:SUNPHARMA)) announced an update on their ongoing clinical study.
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Sun Pharmaceutical Industries Limited has recently completed a post-authorization safety study titled ‘A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)’. The study aimed to collect real-world safety data on the use of sonidegib in adult patients with laBCC, focusing on major safety parameters such as treatment-related deaths, adverse events, and discontinuations due to adverse effects.
The intervention being tested is sonidegib, a drug administered orally at a dose of 200 mg once daily, with dose modifications allowed as per local prescribing information. Sonidegib is intended for patients with laBCC who are not suitable for curative surgery or radiation therapy.
This observational study followed a cohort model with a prospective time perspective. It was designed to monitor patients over a three-year period without imposing specific treatment protocols or visit schedules, reflecting routine clinical practice.
The study began on March 11, 2019, and was completed with the last update submitted on June 23, 2025. These dates are crucial as they mark the timeline of data collection and analysis, providing a comprehensive view of the long-term safety of sonidegib.
The completion of this study could positively influence Sun Pharmaceutical’s stock performance by reinforcing investor confidence in the safety profile of sonidegib, potentially enhancing its market position. The results may also impact the competitive landscape, as other companies in the oncology sector monitor these findings closely.
The study is now completed, and further details are available on the ClinicalTrials portal.