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Soleno Therapeutics Announces Publication of Results from Pivotal Study of VYKAT™ XR in the Journal of Clinical Endocrinology and Metabolism
REDWOOD CITY, Calif., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced a publication in the peer-reviewed Journal of Clinical Endocrinology and Metabolism (JCEM). The paper, titled, “Diazoxide Choline Extended-Release Tablets in Prader-Willi Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal Period Study,” details results from the 16-week randomized withdrawal study (C602-RWP) of VYKAT™ XR (also known as diazoxide choline extended-release tablets, or DCCR) in children and adults 4 years and older with hyperphagia in Prader-Willi syndrome (PWS). The paper can be accessed online here. The randomized withdrawal period study was a key part of the comprehensive Phase 3 clinical program that established the efficacy and safety of VYKAT XR and supported its approval by the U.S. Food and Drug Administration (FDA) as the first and only treatment for hyperphagia in people living with PWS. This clinical program included 127 participants with over 400 patient years of drug exposure, including individuals with nearly six years of continuous treatment. “This important study provided additional controlled data confirming the safety and efficacy of VYKAT XR in people with PWS, and we are pleased that the positive results have been accepted for publication in JCEM, the world’s leading peer-reviewed journal focused on cutting-edge endocrine and metabolic research,” said Dr. Anish Bhatnagar, Chief Executive Officer and Chairman of the Board of Soleno Therapeutics. “Our strong momentum since commercial launch reflects both the significant unmet need that VYKAT XR addresses as the first FDA-approved treatment for the hallmark feature of PWS – hyperphagia – as well as the meaningful therapeutic benefit that it can offer to people living with this rare and complex genetic condition.” Dr. Jennifer Miller, M.D., Professor of Pediatric Endocrinology at the University of Florida, Gainesville, and lead author of the paper, added, “The compelling results of the randomized withdrawal study highlighted in JCEM further reinforce the meaningful and sustained benefit of VYKAT XR in people living with hyperphagia caused by PWS. Notably, when study participants were transitioned to placebo during the ra...