Foundation for Prader-Willi Blog

Six-Month Setmelanotide Data Show Benefits in PWS

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 ...

June 16, 2026 Read More

Topics: Research, Clinical Trials, PWS Research, Hyperphagia, Trial Results

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

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, an...

May 22, 2026 Read More

Topics: Clinical Trials

Aardvark Therapeutics to Unblind Data Following FDA Clinical Hold

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.

May 14, 2026 Read More

Topics: Clinical Trials

Clinical Trials Matter: Three PWS Families Share Their Views

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.

May 13, 2025 Read More

Topics: Clinical Trials

Webinar Provides Details on COMPASS PWS Clinical Trial

In a recent webinar, Acadia Pharmaceuticals shared details of their COMPASS-PWS Clinical trial which is currently enrolling volunteers with PWS between the ages of 5 and 30 who experience hyperphagia. This phase 3 clinical trial aims to evaluate the ...

September 5, 2024 Read More

Topics: Clinical Trials

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

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 the efficacy of Pitoli...

June 18, 2024 Read More

Topics: Research, Clinical Trials

Clinical Trials Panel [2023 Conference Video]

In this one hour and 8-minute video, Dr. Theresa Strong, FPWR’s Director of Research Programs, explores PWS clinical trials that are already underway or enrolling participants.

April 23, 2024 Read More

Topics: Research, Clinical Trials, Family Conference

Harmony Biosciences Initiates Global Phase 3 Study of Pitolisant: TEMPO!

Harmony Biosciences has initiated its Phase 3 study of Pitolisant and is now enrolling individuals with Prader-Willi syndrome ages 6 and up who struggle with excessive daytime sleepiness. Two clinical trial sites are already open and ready to begin s...

April 3, 2024 Read More

Topics: Clinical Trials

VNS4PWS Clinical Trial Opens for Enrollment

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.

January 8, 2024 Read More

Topics: Research, Clinical Trials

Foundation for Prader-Willi Blog | Clinical Trials

Categories

Six-Month Setmelanotide Data Show Benefits in PWS

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

Aardvark Therapeutics to Unblind Data Following FDA Clinical Hold

Clinical Trials Matter: Three PWS Families Share Their Views

Webinar Provides Details on COMPASS PWS Clinical Trial

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

Clinical Trials Panel [2023 Conference Video]

Harmony Biosciences Initiates Global Phase 3 Study of Pitolisant: TEMPO!

VNS4PWS Clinical Trial Opens for Enrollment

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