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Foundation for Prader-Willi Blog | Clinical Trials (3)

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Harmony Biosciences Announces Topline Results From Phase 2 Pitolisant Study

Today, Harmony Biosciences announced topline data on the primary outcome, excessive daytime sleepiness, from their Phase 2 proof-of-concept trial in patients with Prader-Willi syndrome, or PWS. The study included 65 volunteers, ages 6 to 65, who were...
November 1, 2022 Read More

Topics: Research, Clinical Trials

New Study of ARD-101 Now Enrolling Participants Ages 17-65

ARD-101 is a new, oral therapeutic that has shown promising activity in reducing appetite and promoting weight loss in preclinical (animal model) studies.
February 4, 2022 Read More

Topics: Research, Clinical Trials

Encouraging Update from Soleno Therapeutics Regarding DCCR

Soleno Therapeutics has provided an update following recent interactions with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi synd...
January 24, 2022 Read More

Topics: Research, Clinical Trials

Saniona Initiates Phase 2b Clinical Trial of Tesomet for PWS

Saniona, a clinical-stage biopharmaceutical company focused on rare diseases, has announced the initiation of a Phase 2b clinical trial of Tesomet in patients with Prader-Willi syndrome (PWS).
January 7, 2022 Read More

Topics: Research, Clinical Trials

PWS Clinical Trial Opportunity: Pitolisant

A phase 2 study of Pitolisant is enrolling patients ages 6 to 65 years old to evaluate the safety and impact of an investigational medicine, Pitolisant, for excessive daytime sleepiness, cognition, and behavioral function in people with PWS. A live w...
August 3, 2021 Read More

Topics: Research, Clinical Trials

FDA Encourages Submission of Additional Data for DCCR

Soleno Therapeutics has announced that the FDA will accept additional data from their DESTINY PWS and C602 extension study to determine if the data generated are sufficient to support a potential New Drug Application (NDA) for diazoxide choline contr...
July 6, 2021 Read More

Topics: News, Clinical Trials

FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 for the Treatment of Prader-Willi Syndrome

Levo Therapeutics has announced the FDA has granted Priority Review for its New Drug Application (NDA) for LV-101 (intranasal carbetocin) as a treatment for hyperphagia and behavioral distress associated with PWS. A 6-month Priority Review will accel...
July 6, 2021 Read More

Topics: News, Clinical Trials

Pitolisant for Excessive Daytime Sleepiness in PWS [2020 CONFERENCE VIDEO]

In this 30‑minute video, Albena Patroneva from Harmony Biosciences explains what pitolisant is and how it works, and describes Harmony's Phase 2 clinical trial of pitolisant in patients with PWS. The session includes Q&A from participants in the ...
June 15, 2021 Read More

Topics: Research, Clinical Trials, Family Conference

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The Foundation for Prader-Willi Research (federal tax id 31-1763110) is a nonprofit corporation with federal tax exempt status as a public charity under section 501(c)(3).

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The mission of FPWR is to eliminate the challenges of Prader-Willi syndrome through the advancement of research and therapeutic development.

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