Tonix plans Phase 2 trial of TNX-2900 for Prader-Willi syndrome in 2026

Tonix Pharmaceuticals Holding Corp.

TNX-2900 (intranasal magnesium-potentiated oxytocin) to enter Phase 2 in children ages 8-17.5 with PWS, starting 2026.
FDA cleared IND; Orphan Drug and Rare Pediatric Disease designations; eligible for Priority Review Voucher upon approval.
Phase 2 trial is randomized, double-blind, placebo-controlled; 12-week treatment; 3 dose arms vs placebo (1:1:1:1).
Primary endpoint: change from baseline in Hyperphagia Questionnaire (HQ-CT); secondary: behavior, caregiver burden, quality of life.
PWS affects 1 in 10,000-30,000 births; average life expectancy <30 years due to hyperphagia-driven obesity.

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