Prader-Willi syndrome

Last reviewed

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ORPHA:739OMIM:176270Q87.1
Who is this for?
Show terms as
2FDA treatments19Active trials20Specialists8Treatment centers2Financial resources

Where are you in your journey?

UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Prader-Willi syndrome is treated with 1 medication in our database, including VYKAT XR. 1 of these has manufacturer assistance programs available to help reduce out-of-pocket costs. Medications are manufactured by AstraZeneca. Patients and caregivers can find copay cards, patient assistance programs, and travel grants for Prader-Willi syndrome treatment below.

Also known as:

Clinical phenotype terms— hover any for plain English:

Abnormal rapid eye movement sleepHP:0002494GastroparesisHP:0002578Increased susceptibility to fracturesHP:0002659Obstructive sleep apneaHP:0002870External genital hypoplasiaHP:0003241Borderline intellectual disabilityHP:0006889Central sleep apneaHP:0010536Impaired temperature sensationHP:0010829Small pituitary glandHP:0012506Perisylvian polymicrogyriaHP:0012650Abdominal obesityHP:0012743Decreased circulating gonadotropin concentrationHP:0030339Reduced circulating growth hormone concentrationHP:0034323
Inheritance

Variable

Can be inherited in different ways depending on the underlying gene

Age of Onset

Neonatal

Begins at or shortly after birth (first 4 weeks)

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Mar 2026A Study of CSTI-500 in Patients With Prader-Willi Syndrome

ConSynance Therapeutics — PHASE2

TrialNOT YET RECRUITING
Jan 2026A 2-Part Study to Assess Efficacy, Safety and Tolerability of BMB-101 for the Treatment of Patients With Prader-Willi Syndrome.

Bright Minds Biosciences Pty Ltd — PHASE2

TrialNOT YET RECRUITING
Nov 2025Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome

Soleno Therapeutics, Inc.

TrialENROLLING BY INVITATION
Aug 2025A Study of Pitolisant in Participants With Prader-Willi Syndrome

Harmony Biosciences Management, Inc. — PHASE3

TrialENROLLING BY INVITATION
Jun 2025Brain Olfactory Pathways in Prader-Willi Syndrome

University Hospital, Toulouse — NA

TrialNOT YET RECRUITING
May 2025Tirzepatide in PWS, HO and GNSO

Grace Kim — PHASE4

TrialRECRUITING
Apr 2025Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome

University Hospital, Toulouse

TrialRECRUITING
Mar 2025Vykat Xr: FDA approved

treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS)

FDAcompleted
Mar 2025A Study of Setmelanotide in Patients With Prader-Willi Syndrome

Rhythm Pharmaceuticals, Inc. — PHASE2

TrialACTIVE NOT RECRUITING
May 2024A Study of Pitolisant in Patients With Prader-Willi Syndrome

Harmony Biosciences Management, Inc. — PHASE3

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

2 available

Norditropin

SOMATROPIN· Novo Nordisk

growth failure due to Prader-Willi Syndrome (PWS)

Vykat Xr

DIAZOXIDE CHOLINE· Soleno Therapeutics, Inc.Orphan Drug

treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS)

Clinical Trials

19 recruitingView all trials with filters →
Phase 37 trials
Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
Phase 3
Active
· Sites: Birmingham, Alabama; Phoenix, Arizona +28 more · Age: 530 yrs
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
Phase 3
Active
· Sites: Orange, California; Palo Alto, California +20 more · Age: 499 yrs
A Study of Pitolisant in Participants With Prader-Willi Syndrome
Phase 3
Enrolling by Invitation
PI: David Seiden, MD (Harmony Biosciences Management, Inc.) · Sites: Morrisville, North Carolina · Age: 799 yrs
A Study of Pitolisant in Patients With Prader-Willi Syndrome
Phase 3
Actively Recruiting
· Sites: Los Angeles, California; Sacramento, California +52 more · Age: 699 yrs
Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial
Phase 3
Actively Recruiting
PI: Maithé TAUBER, MD (University Hospital, Toulouse) · Sites: Bron; Dijon +10 more
OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
Phase 3
Enrolling by Invitation
· Sites: Birmingham, Alabama; Phoenix, Arizona +28 more · Age: 530 yrs
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
Phase 3
Actively Recruiting
PI: Theresa Strong, PhD (Foundation for Prader-Willi Research) · Sites: Palo Alto, California; San Diego, California +16 more · Age: 1040 yrs
Phase 41 trial
Tirzepatide in PWS, HO and GNSO
Phase 4
Actively Recruiting
· Sites: Saint Paul, Minnesota; Nashville, Tennessee +1 more · Age: 1826 yrs
Phase 22 trials
A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension
Phase 2
Active
· Sites: San Diego, California; San Ramon, California +11 more · Age: 665 yrs
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
Phase 2
Active
PI: David Meeker, MD (Rhythm Pharmaceuticals, Inc.) · Sites: Gainesville, Florida · Age: 665 yrs
N/A5 trials
GROWing Up With Rare GENEtic Syndromes
N/A
Actively Recruiting
· Sites: Rotterdam, South Holland · Age: 1899 yrs
Cerebellar TMS and Satiety in Prader-Willi Syndrome
N/A
Actively Recruiting
PI: Laura Holsen, PhD (Brigham and Women's Hospital) · Sites: Belmont, Massachusetts · Age: 1864 yrs
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
N/A
Actively Recruiting
PI: Wei Lu, Dr (Children's Hospitial of Fudan Univeristy) · Sites: Shanghai, Shanghai Municipality · Age: 310 yrs
Impact of Bright Light Therapy on Prader-Willi Syndrome
N/A
Actively Recruiting
PI: Deepan Singh, MD (Maimonides Medical Center) · Sites: Brooklyn, New York · Age: 688 yrs
Effects of Transcutaneous Vagus Nerve Stimulation on Emotion Regulation and Executive Functioning in Prader-Willi Syndrome
N/A
Actively Recruiting
PI: Virginie Postal, PhD (University of Bordeaux) · Sites: Bordeaux; Hendaye +2 more · Age: 1899 yrs
Other4 trials
Biological Age Assessment in Adults With Prader-Willi Syndrome (ETABIOLPWS)
Active
· Sites: Oggebbio, Verbania · Age: 1899 yrs
Register of Patients With Prader-Willi Syndrome
Actively Recruiting
PI: Tauber Maité, MD (University Hospital, Toulouse) · Sites: Toulouse
Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome
Actively Recruiting
PI: Sophie Cabal (University Hospital of Toulouse) · Sites: Toulouse · Age: 316 yrs
Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
Enrolling by Invitation
· Sites: Indianapolis, Indiana; Lansing, Michigan · Age: 499 yrs

Specialists

20 foundView all specialists →
AH
Anthony Holland
MADISON, WI
Specialist
2 Prader-Willi syndrome publications
AC
Assumpta Caixàs
Specialist
2 Prader-Willi syndrome publications
MA
Moris Angulo
MINEOLA, NY
Specialist
2 Prader-Willi syndrome publications
BW
Barbara Y Whitman
RUDOLPH, OH
Specialist
2 Prader-Willi syndrome publications
AG
Anthony P Goldstone
Specialist
2 Prader-Willi syndrome publications
SK
Shankar Kanumakala
Specialist
2 Prader-Willi syndrome publications
MB
Merlin G Butler
KANSAS CITY, KS
Specialist
7 Prader-Willi syndrome publications
JM
Jennifer L Miller
Specialist
3 Prader-Willi syndrome publications
CH
Charlotte Höybye
Specialist
3 Prader-Willi syndrome publications
JD
Jessica Duis
AURORA, CO
Specialist
3 Prader-Willi syndrome publications
NB
Nicola Bridges
MILWAUKIE, OR
Specialist
2 Prader-Willi syndrome publications
KO
Kathryn S Obrynba
COLUMBUS, OH
Specialist
2 Prader-Willi syndrome publications
LB
Lynne M Bird
GRAND JUNCTION, CO
Specialist
2 Prader-Willi syndrome publications
WP
Wendy J Dahl, PhD
UPTON, MA
Specialist
PI on 2 active trials
MP
Marcelo Serra, PhD
Buenos Aires, Buenos Aires
Specialist

Rare Disease Specialist

PI on 1 active trial
GG
Graziano Grugni
Specialist
3 Prader-Willi syndrome publications
AB
Anish Bhatnagar
NEWARK, NJ
Specialist
3 Prader-Willi syndrome publications
MB
Merlin G. Butler
KANSAS CITY, KS
Specialist
PI on 1 active trial
KK
Kim Krogsgaard
Specialist
PI on 1 active trial
JC
Jean-Pierre Chanoine
Specialist
PI on 1 active trial

Treatment Centers

8 centers
⚗️ Trial Site

Erasmus Medical Center

📍 Rotterdam

👤 Robert Rissmann, Professor

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

Financial Resources

2 resources
Norditropin(SOMATROPIN)Novo Nordisk
Vykat Xr(DIAZOXIDE CHOLINE)Soleno Therapeutics, Inc.

Travel Grants

No travel grants are currently matched to Prader-Willi syndrome.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Prader-Willi syndrome

1 articles
AdvocacyRSSApr 22, 2026
Our Children’s Strengths Are Real, but PWS Makes Them Harder to See
Children with Prader-Willi Syndrome (PWS) have real character strengths and positive qualities, but the challenges of the condition can make these strengths dif
See all news about Prader-Willi syndrome

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Prader-Willi syndrome

What is Prader-Willi syndrome?

Prader-Willi syndrome is treated with 1 medication in our database, including VYKAT XR. 1 of these has manufacturer assistance programs available to help reduce out-of-pocket costs. Medications are manufactured by AstraZeneca. Patients and caregivers can find copay cards, patient assistance programs, and travel grants for Prader-Willi syndrome treatment below.

At what age does Prader-Willi syndrome typically begin?

Typical onset of Prader-Willi syndrome is neonatal. Age of onset can vary across affected individuals.

Are there clinical trials for Prader-Willi syndrome?

Yes — 19 recruiting clinical trials are currently listed for Prader-Willi syndrome on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Prader-Willi syndrome?

20 specialists and care centers treating Prader-Willi syndrome are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Prader-Willi syndrome?

1 FDA-approved treatment and 2 patient support programs are currently tracked on UniteRare for Prader-Willi syndrome. See the treatments and support programs sections for copay assistance, eligibility, and contact details.