Hyperphagia — an overwhelming and constant drive to eat — is one of the most challenging symptoms of Prader-Willi Syndrome (PWS). It can lead to serious health issues and often means individuals need 24/7 supervision to stay safe. That’s why finding effective treatments for hyperphagia is a top priority in PWS research.
Exciting news has been released from Tonix Pharmaceuticals who have announced plans to launch a new clinical trial in 2026 to test a potential treatment called TNX-2900.
What is TNX-2900?
TNX-2900 is a specially designed version of oxytocin, a hormone that helps regulate hunger, social bonding, and behaviour. Research has shown that people with PWS often have lower levels of natural oxytocin, making it a promising target for treatment.
You might note that Carbetocin, a drug developed by Acadia Pharmaceuticals, was also aimed to boost oxytocin levels to reduce hyperphagia. Unfortunately, that trial didn’t show strong enough results, and development was stopped. However, TNX-2900 is a different kind of oxytocin drug to Carbetocin. While it’s also delivered as a nasal spray, the oxytocin is enhanced with magnesium. The magnesium is designed to help the oxytocin work more effectively by improving how it binds to the right receptors in the brain — potentially making it more precise and consistent than previous treatments.
What Will the Trial Look Like?
This will be a Phase 2 trial, which means it is still early in the testing process and will involve a smaller group of participants. The goal is to understand how well the drug works and what the right dose might be.
Children and teens with PWS aged 8 to 17.5 years will be randomly assigned to receive one of three doses of TNX-2900 or a placebo over a 12-week period. Researchers will track changes in hunger-related behaviours using a validated questionnaire called the HQ-CT, and will also look at caregiver burden, quality of life, and safety.
Why Is This Exciting?
TNX-2900 has already received Orphan Drug and Rare Paediatric Disease designations from the U.S. FDA. These special statuses can help speed up the approval process if the trial shows positive results, potentially bringing a much-needed treatment to families sooner.
You can read Tonix’s full announcement here- https://ir.tonixpharma.com/news-events/press-releases/detail/1590/tonix-pharmaceuticals-plans-to-initiate-prader-willi and we’ll continue to follow this development closely, sharing updates as they become available.