Sandoz Group Ltd (SDZXF) announced an update on their ongoing clinical study.
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Study Overview: Sandoz Group Ltd is conducting a clinical study titled A Randomized, Multicenter, Multiple-dose, Double-blind, Placebo-controlled, Parallel-group Design, Clinical Endpoint Bioequivalence Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (Fluticasone Furoate and Vilanterol Inhalation Powder) 100 mcg/25 mcg (GlaxoSmithKline) in Adult Participants With Asthma. The study aims to assess the therapeutic equivalence and safety of Sandoz’s inhalation powder compared to BREO ELLIPTA in adults with asthma, which could have significant implications for treatment options in respiratory conditions.
Intervention/Treatment: The study tests Fluticasone Furoate and Vilanterol inhalation powder, a combination product intended to manage asthma symptoms. It is compared against BREO ELLIPTA and a placebo to determine its efficacy and safety.
Study Design: This is an interventional study with a randomized, parallel-group design. Participants and investigators are both blinded to the treatment allocation. The primary purpose is to evaluate treatment efficacy, with participants receiving either the experimental drug, an active comparator, or a placebo.
Study Timeline: The study is not yet recruiting, with the initial submission date on October 15, 2025, and the latest update on December 11, 2025. These dates are crucial as they mark the progress and regulatory compliance of the study.
Market Implications: This study could influence Sandoz’s stock performance by potentially expanding its product portfolio in the respiratory market. Positive outcomes may enhance investor sentiment, especially as it positions itself against competitors like GlaxoSmithKline. The study’s results could shift market dynamics in favor of Sandoz if therapeutic equivalence is established.
The study is ongoing, with further details available on the ClinicalTrials portal.
To learn more about SDZXF’s potential, visit the Sandoz Group Ltd drug pipeline page.