Kennedy disease

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ORPHA:481OMIM:313200G12.2
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6Active trials32Specialists8Treatment centers

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

Kennedy disease, also known as spinal and bulbar muscular atrophy (SBMA) or X-linked bulbospinal neuronopathy, is a rare, slowly progressive neurodegenerative disorder caused by a trinucleotide (CAG) repeat expansion in the androgen receptor (AR) gene on the X chromosome. The disease primarily affects males and is characterized by degeneration of lower motor neurons in the brainstem and spinal cord, leading to progressive muscle weakness and atrophy. Because the androgen receptor is involved, the condition also has significant endocrine manifestations. Key clinical features include proximal limb muscle weakness and wasting, bulbar symptoms such as difficulty swallowing (dysphagia), slurred speech (dysarthria), and tongue fasciculations. Patients frequently experience muscle cramps, tremor, and widespread fasciculations. Sensory neuropathy may also be present. Endocrine-related signs include gynecomastia (breast enlargement), testicular atrophy, reduced fertility, and erectile dysfunction. Elevated creatine kinase (CK) levels are commonly found on laboratory testing. Symptoms typically begin between the ages of 30 and 50, though onset can vary. Kennedy disease progresses slowly, and most patients remain ambulatory for many years after symptom onset, though some may eventually require wheelchair assistance. Life expectancy is generally near normal, though aspiration pneumonia due to bulbar dysfunction can be a serious complication. There is currently no cure or disease-modifying treatment for Kennedy disease. Management is supportive and multidisciplinary, including physical therapy, speech therapy, nutritional support for swallowing difficulties, and endocrine management. Clinical trials have investigated androgen-reducing therapies such as leuprorelin and dutasteride, but results have been inconclusive. Genetic counseling is important for affected families, as carrier females are generally asymptomatic or may have mild symptoms such as muscle cramps.

Also known as:

Clinical phenotype terms— hover any for plain English:

Testicular atrophyHP:0000029Abnormal circulating lipid concentrationHP:0003119Erectile dysfunctionHP:0100639
Inheritance

X-linked recessive

Carried on the X chromosome; typically affects males more than females

Age of Onset

Adult

Begins in adulthood (age 18 or older)

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
May 2026Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer

University Health Network, Toronto — PHASE2

TrialNOT YET RECRUITING
Apr 2026High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)

Cedars-Sinai Medical Center — PHASE2

TrialNOT YET RECRUITING
Mar 2026Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer

TechnoGenesys, Inc. — PHASE1

TrialRECRUITING
Mar 2026Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — PHASE2

TrialRECRUITING
Mar 2026Pacritinib in Participants With Metastatic Castrate-Resistant Prostate Cancer That Progressed on or After Prior Treatment With Androgen Receptor Signaling Inhibitors

Medical College of Wisconsin — PHASE2

TrialNOT YET RECRUITING
Feb 2026A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Jiangsu HengRui Medicine Co., Ltd. — PHASE3

TrialRECRUITING
Dec 2025A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC

Novartis Pharmaceuticals — PHASE1, PHASE2

TrialRECRUITING
Nov 2025An Observational Study to Learn More About How Medicines That Block Male Hormones Are Used in People With Prostate Cancer in Australia

Bayer

TrialNOT YET RECRUITING
Oct 2025Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer

Ankara Etlik City Hospital

TrialRECRUITING
Oct 2025Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

Amgen — PHASE1

TrialRECRUITING

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

Treatments

No FDA-approved treatments are currently listed for Kennedy disease.

6 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

6 recruitingView all trials with filters →
Phase 21 trial
A Placebo-controlled Study of Clenbuterol in Spinal and Bulbar Muscular Atrophy
Phase 2
Actively Recruiting
PI: Gianni Sorarù, MD (Azienda Ospedale Università di Padova) · Sites: Padua, PD · Age: 1875 yrs
N/A2 trials
Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)
N/A
Actively Recruiting Prior treatment eligible
PI: Christopher Grunseich, M.D. (National Institute of Neurological Disorders and S) · Sites: Bethesda, Maryland · Age: 18120 yrs
Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
N/A
Actively Recruiting
PI: Study Director (Takeda) · Sites: Tokyo
Other2 trials
International SBMA Project (KDA)
Active
PI: Silvia Fenu, MD (Fondazione IRCCS Istituto Neurologico Carlo Besta) · Sites: Milan · Age: 1899 yrs
ALS/MND Natural History Study Data Repository
Actively Recruiting
PI: Alexander Sherman (Massachusetts General Hospital) · Sites: Loma Linda, California; Los Angeles, California +14 more · Age: 1890 yrs

Specialists

Showing 25 of 32View all specialists →
GP
Gaelle Bruneteau, MD, PhD
Specialist
PI on 2 active trials
DB
Dipti Baskar
Specialist
1 Kennedy disease publication
PV
Preethish Veeramani-Kumar
Specialist
1 Kennedy disease publication
DM
Deepak Menon
Specialist
1 Kennedy disease publication
AT
Aneesha Thomas
Specialist
1 Kennedy disease publication
KS
Keerthipriya Muddasu Suhasini
Specialist
1 Kennedy disease publication
AH
Akshata Huddar
Specialist
1 Kennedy disease publication
BC
Ben-Chi Cai
Specialist
1 Kennedy disease publication
SS
Sai Bhargava Sanka
NASHVILLE, TN
Specialist
1 Kennedy disease publication
CP
Chiara Marini-Bettolo, MD, PhD
Newcastle upon Tyne
Specialist

Rare Disease Specialist

PI on 3 active trials
CM
Christopher Grunseich, M.D.
Bethesda, Maryland
Specialist

Rare Disease Specialist

PI on 5 active trials
EM
Evanthia Galanis, MD
ROCHESTER, MN
Specialist
PI on 9 active trials
JC
Jeremie Calais
LOS ANGELES, CA
Specialist
PI on 4 active trials
WP
William D Figg, Pharm.D.
BETHESDA, MD
Specialist
PI on 4 active trials
WX
Wen-Di Xu
Specialist
1 Kennedy disease publication
DP
Douglas McNeel, MD, PhD
St Louis, Missouri
Specialist

Rare Disease Specialist

PI on 3 active trials
LZ
Li-Fan Zhong
Specialist
1 Kennedy disease publication
YL
Yan-Hui Liu
Specialist
1 Kennedy disease publication
ZS
Zhi-Yan Sui
Specialist
1 Kennedy disease publication
QY
Qiang Yang
Specialist
1 Kennedy disease publication
DZ
Dan-Ting Zeng
Specialist
1 Kennedy disease publication

Treatment Centers

8 centers
⚗️ Trial Site

National Institutes of Health Clinical Center

📍 Bethesda, Maryland

👤 Payal P Khincha, M.D.

👤 Christopher Grunseich, M.D.

🏥 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

Travel Grants

No travel grants are currently matched to Kennedy disease.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Kennedy disease

Disease timeline:

New recruiting trial: ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate

A new clinical trial is recruiting patients for Kennedy disease

New recruiting trial: Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

A new clinical trial is recruiting patients for Kennedy disease

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 Kennedy disease

What is Kennedy disease?

Kennedy disease, also known as spinal and bulbar muscular atrophy (SBMA) or X-linked bulbospinal neuronopathy, is a rare, slowly progressive neurodegenerative disorder caused by a trinucleotide (CAG) repeat expansion in the androgen receptor (AR) gene on the X chromosome. The disease primarily affects males and is characterized by degeneration of lower motor neurons in the brainstem and spinal cord, leading to progressive muscle weakness and atrophy. Because the androgen receptor is involved, the condition also has significant endocrine manifestations. Key clinical features include proximal l

How is Kennedy disease inherited?

Kennedy disease follows a x-linked recessive inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Kennedy disease typically begin?

Typical onset of Kennedy disease is adult. Age of onset can vary across affected individuals.

Are there clinical trials for Kennedy disease?

Yes — 6 recruiting clinical trials are currently listed for Kennedy disease on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Kennedy disease?

25 specialists and care centers treating Kennedy disease are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.