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Clinical Trials

Six-Month Setmelanotide Data Show Benefits in PWS

June 16, 2026

Rhythm Pharmaceuticals recently shared encouraging six-month results from its ongoing Phase 2 clinical trial of setmelanotide in people with Prader-Willi syndrome (PWS). The findings, presented at ENDO 2026, suggest that treatment with setmelanotide may help improve not only weight and

Phase 2 Clinical Trial for Prader-Willi Syndrome Now Enrolling: CSTI-500

May 22, 2026

A new phase 2 study is evaluating CSTI-500, an investigational medication being developed to address some of the most challenging symptoms of PWS, including hyperphagia and behavioral dysregulation. Researchers will study the safety, tolerability, and potential effectiveness of the medication

Aardvark Therapeutics to Unblind Data Following FDA Clinical Hold

May 14, 2026

Aardvark Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company’s previously announced voluntary pause. The clinical hold applies to

Caregiver Perspectives: Insights on the COMPASS-PWS Trial

November 13, 2025

Background In response to Acadia Pharmaceuticals’ announcement that the COMPASS-PWS Phase 3 trial of intranasal carbetocin did not meet its primary or secondary endpoints and would not advance further, the Foundation for Prader-Willi Research (FPWR) convened a patient forum to

Clinical Trials Matter: Three PWS Families Share Their Views

May 13, 2025

Harmony Biosciences recently met with three families impacted by Prader-Willi syndrome (PWS) to better understand their views on clinical trials for PWS symptoms including excessive daytime sleepiness. A lot has changed since PWS was first identified and named in 1956,

Webinar: What You Can Expect if You Participate in TEMPO, a Phase 3 Trial of Pitolisant

June 18, 2024

If your loved one with PWS struggles with daytime sleepiness, you may be interested in learning more about TEMPO, a phase 3 study of Pitolisant, now enrolling volunteers with PWS ages 6 to 65 years old. This study will evaluate

VNS4PWS Clinical Trial Opens for Enrollment

January 8, 2024

The Foundation for Prader-Willi Research is pleased to announce our VNS4PWS clinical trial is now open and enrolling participants with PWS ages 10-40 who experience disruptive behaviors and temper outbursts. Vagus Nerve Stimulation (VNS) uses brief electrical impulses to stimulate

Soleno Therapeutics Announces Positive Statistically Significant Top-line Results from Randomized Withdrawal Period of Study C602 of DCCR for Prader-Willi Syndrome

September 26, 2023

We are excited to share the news that Soleno has announced positive, statistically significant top-line results from the randomized withdrawal period of study c602 of DCCR for Prader-Willi Syndrome. In the study, patients taking DCCR showed a highly significant improvement

Aardvark Announces Rare Disease Designation and Expands Ongoing Phase 2 Trial

August 3, 2023

Aardvark Therapeutics, a clinical stage biopharmaceutical company, has reported receipt of a Rare Pediatric Disease Designation in Prader-Willi Syndrome (PWS) from the FDA for its lead program ARD-101. This designation means Aardvark is eligible for a Rare Pediatric Disease Priority

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