Current Report No. 17/2026 – Positive Results of the Bioequivalence Study of Celon Semaglutide (Reduzek)

Legal basis: Article 17(1) of the Market Abuse Regulation (MAR) – Inside Information
Date and time: 20 August 2026, 11:33

The Management Board of Celon Pharma S.A. (the “Company”) hereby announces that the Company has obtained positive results from a bioequivalence study of its semaglutide-containing medicinal product, Reduzek, currently under development by the Company.

The objective of the study was to demonstrate the bioequivalence of Celon Semaglutide 0.5 mg (Reduzek) to the reference medicinal products Wegovy® (semaglutide) 0.5 mg and Ozempic® (semaglutide) 0.5 mg, administered subcutaneously.

The study was designed as a randomized, open-label, single-dose, parallel-group bioequivalence study and was conducted under fasting conditions in 91 healthy volunteers in Canada.

The study demonstrated the bioequivalence of Celon Semaglutide 0.5 mg (Reduzek) to both Wegovy® and Ozempic®. For the primary pharmacokinetic parameters, AUC(0–t) and Cmax, the 90% confidence intervals for the ratios of geometric means fell within the predefined bioequivalence acceptance range of 80.00%–125.00%, in accordance with the ICH M13A guideline.

The results confirm that the rate and extent of absorption of Celon Semaglutide (Reduzek) are comparable to those of the reference medicinal products Wegovy® and Ozempic®, thereby confirming that the applicable bioequivalence criteria have been met.

The positive results of the study enable the bioequivalence findings to be extrapolated to the remaining strengths of the products, in accordance with the applicable bioequivalence guidelines.

The study represents a significant milestone in the development of Celon Semaglutide (Reduzek) as an equivalent of Novo Nordisk’s Ozempic® and Wegovy® medicinal products and constitutes an important element of the Company’s strategy for the future commercialization of the product in global markets.