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Home » Opterion Health AG Announces First Patient enrolled in Phase 1 SPARC Trial Following CTA Approval for OPT101
Press Release

Opterion Health AG Announces First Patient enrolled in Phase 1 SPARC Trial Following CTA Approval for OPT101

By News RoomFebruary 23, 20262 Mins Read
Opterion Health AG Announces First Patient enrolled in Phase 1 SPARC Trial Following CTA Approval for OPT101
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MUTTENZ, Switzerland, Feb. 23, 2026 (GLOBE NEWSWIRE) — Opterion Health AG today announced that the first patient has been successfully enrolled in its Phase 1 SPARC trial. This marks the official start of the company’s first-in-human clinical development program for OPT101, its non-glucose-based osmotic agent designed to transform peritoneal dialysis (PD). This milestone follows the Clinical Trial Application (CTA) approval recently granted by the European health authorities, clearing the way for study initiation. 

The Phase 1 SPARC trial evaluates safety, tolerability, and pharmacokinetics across multiple OPT101 concentrations during controlled day and night dwell cycles, alongside patient-reported outcomes. The data will guide the next stages of development aimed at replacing today’s glucose-based solutions.

“First patient enrolled is a powerful and motivating moment for the entire organization,” said Peter Reinemer, Chief Executive Officer of Opterion Health AG. “For more than three decades, patients on peritoneal dialysis have had to rely on glucose-based solutions that come with significant compromises. With OPT101, we are determined to give patients with chronic kidney disease (CKD) better options. Today’s milestone proves we are well on our way.” 

Maxim Voropaiev, Chief Medical Officer, added: “First patient in gives us the clinical starting point we need. SPARC will tell us how OPT101 behaves, how patients experience it, and how we should shape future phases. Everything we learn from this study moves us closer to offering a therapy that reduces metabolic burden and supports longer-lasting, more patient-friendly PD care.” 

For more than 30 years, PD patients have relied on glucose-based solutions that drive metabolic distress, insulin spikes, weight gain, and which lead to glucose toxicity — a key driver of progressive peritoneal membrane deterioration. OPT101 is designed to change this dynamic, addressing long-standing unmet needs in a fast-growing global CKD population.

About Opterion Health AG
Opterion Health AG is a Swiss-based biopharmaceutical company focused on transforming renal care through the development of novel therapies for peritoneal dialysis patients. Its lead candidate, OPT101, is designed to improve the quality of life of patients undergoing peritoneal dialysis and changing the odds of PD outcomes for those who rely on life-saving treatments.

For further information, please contact:
[email protected]
www.opterion.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/09d91a22-d45f-4dd9-855b-2793e8b243d2

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