Aromatic L-amino acid decarboxylase deficiency

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ORPHA:35708OMIM:608643G24.8
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1FDA treatments3Active trials30Specialists8Treatment centers

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

Aromatic L-amino acid decarboxylase deficiency, also known as AADC deficiency, is a rare inherited disorder that affects how the brain and nervous system work. It is caused by problems with an enzyme called aromatic L-amino acid decarboxylase, which the body needs to make important chemical messengers called neurotransmitters. These messengers — including dopamine, serotonin, epinephrine, and norepinephrine — help nerve cells communicate with each other and control movement, mood, sleep, and many automatic body functions. When this enzyme does not work properly, the brain cannot produce enough of these chemical messengers. This leads to a wide range of symptoms that usually appear in the first few months of life. The most noticeable problems involve movement — children often have very weak muscle tone (called hypotonia), difficulty controlling their movements, and episodes of abnormal eye or body movements called oculogyric crises. Many children also have developmental delays, feeding difficulties, and problems with automatic body functions like sweating, temperature control, and blood pressure. Treatment has historically focused on managing symptoms using medications that try to compensate for the missing neurotransmitters. In 2023, the FDA approved the first gene therapy for AADC deficiency, called eladocagene exuparvovec (Upstaza), which delivers a working copy of the affected gene directly into the brain. This represents a major step forward, though access and long-term outcomes are still being studied.

Also known as:

Key symptoms:

Very low muscle tone (floppy baby appearance)Difficulty controlling voluntary movementsEpisodes of abnormal eye rolling or eye deviation (oculogyric crises)Developmental delays — delayed sitting, standing, and walkingFeeding difficulties and poor weight gainExcessive sweatingRunny nose without illnessDrooping eyelids (ptosis)Irritability and crying episodesTemperature instabilityLow blood pressureSleep disturbancesLimited or absent speech developmentSmall or constricted pupils

Clinical phenotype terms (38)— hover any for plain English
Decreased CSF homovanillic acid concentrationHP:0003785Decreased CSF 5-hydroxyindolacetic acid concentrationHP:0025455Oculogyric crisisHP:0010553MiosisHP:0000616
Inheritance

Autosomal recessive

Passed on when both parents carry the same gene change; often skips generations

Age of Onset

Infantile

Begins in infancy, roughly 1 month to 2 years old

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

5 events
Nov 2024

Kebilidi: FDA approved

treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency

FDAcompleted
May 2024A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Severe AADC Deficiency

Shanghai Vitalgen BioPharma Co., Ltd. — PHASE1

TrialNOT YET RECRUITING
Jan 2023An Early Clinical Trial to Evaluate VGN-R09b for Treatment of Aromatic L-amino Acid Decarboxylase (AADC) Deficiency.

Shanghai Jiao Tong University School of Medicine — EARLY_PHASE1

TrialRECRUITING
May 2021A Study of SmartFlow Magnetic Resonance (MR) Compatible Ventricular Cannula for Administering Eladocagene Exuparvovec to Pediatric Participants

PTC Therapeutics — PHASE2

TrialACTIVE NOT RECRUITING
Jul 2016A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients

Krzysztof Bankiewicz — PHASE1

TrialRECRUITING

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

Treatments

1 available

Kebilidi

eladocagene exuparvovec-tneq· PTC Therapeutics, Inc.Orphan Drug

treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency

Clinical Trials

3 recruitingView all trials with filters →
Phase 21 trial
A Study of SmartFlow Magnetic Resonance (MR) Compatible Ventricular Cannula for Administering Eladocagene Exuparvovec to Pediatric Participants
Phase 2
Active
· Sites: Boston, Massachusetts; Durham, North Carolina +4 more · Age: 117 yrs
Phase 11 trial
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
Phase 1
Actively Recruiting
PI: Krystof Bankiewicz, MD, PhD (OSU Professor of Neurological Surgery) · Sites: San Francisco, California; Columbus, Ohio +1 more

Specialists

Showing 25 of 30View all specialists →
YM
Yin-Hsiu Chien, MD.,PhD
Specialist
PI on 1 active trial
KP
Krystof Bankiewicz, MD, PhD
Specialist
PI on 1 active trial
WP
Wuh-Liang Hwu, M.D., Ph.D.
Specialist
PI on 1 active trial
MK
Manju A Kurian
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
RB
Roberta Battini
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
MB
Mariarita Bertoldi
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
JS
Jehan Suleiman
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
YC
Yin-Hsiu Chien
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
TP
Toni S Pearson
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
RG
Roberto Giugliani
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
FK
Francyne Kubaski
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
ZH
Zackary M Herbst
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
TO
Thomas Opladen
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
VL
Vincenzo Leuzzi
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
RZ
Rongrong Zhang
SCHAUMBURG, IL
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
CS
Camilo Silva
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
HL
Helio van der Linden
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
CL
Charles M Lourenço
Specialist
3 Aromatic L-amino acid decarboxylase deficiency publications
SA
Sarah Acaster
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
SO
Sian O'Neill
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
HS
Hanna Skrobanski
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
KW
Kate Williams
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
CS
Carlotta Spagnoli
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
GB
Giovanni Bisello
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications
MA
Musaad Abukhaled
Specialist
2 Aromatic L-amino acid decarboxylase deficiency publications

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 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

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Aromatic L-amino acid decarboxylase deficiency.

Search all travel grants →NORD Financial Assistance ↗

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Latest news about Aromatic L-amino acid decarboxylase deficiency

Disease timeline:

New recruiting trial: A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients

A new clinical trial is recruiting patients for Aromatic L-amino acid decarboxylase deficiency

New recruiting trial: An Early Clinical Trial to Evaluate VGN-R09b for Treatment of Aromatic L-amino Acid Decarboxylase (AADC) Deficiency.

A new clinical trial is recruiting patients for Aromatic L-amino acid decarboxylase deficiency

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.

Questions for your doctor

Bring these to your next appointment

  • Q1.Is my child a candidate for gene therapy, and what would the process involve?,What medications are available to help manage oculogyric crises, and how should I respond if one happens at home?,What therapies — physical, occupational, or speech — should my child be receiving, and how often?,Are there any clinical trials or research studies my child could participate in?,What signs should prompt me to seek emergency care?,Should other family members be tested to see if they are carriers?,What support services or patient organizations can help our family?

Common questions about Aromatic L-amino acid decarboxylase deficiency

What is Aromatic L-amino acid decarboxylase deficiency?

Aromatic L-amino acid decarboxylase deficiency, also known as AADC deficiency, is a rare inherited disorder that affects how the brain and nervous system work. It is caused by problems with an enzyme called aromatic L-amino acid decarboxylase, which the body needs to make important chemical messengers called neurotransmitters. These messengers — including dopamine, serotonin, epinephrine, and norepinephrine — help nerve cells communicate with each other and control movement, mood, sleep, and many automatic body functions. When this enzyme does not work properly, the brain cannot produce enoug

How is Aromatic L-amino acid decarboxylase deficiency inherited?

Aromatic L-amino acid decarboxylase deficiency follows a autosomal recessive inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Aromatic L-amino acid decarboxylase deficiency typically begin?

Typical onset of Aromatic L-amino acid decarboxylase deficiency is infantile. Age of onset can vary across affected individuals.

Are there clinical trials for Aromatic L-amino acid decarboxylase deficiency?

Yes — 3 recruiting clinical trials are currently listed for Aromatic L-amino acid decarboxylase deficiency on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Aromatic L-amino acid decarboxylase deficiency?

25 specialists and care centers treating Aromatic L-amino acid decarboxylase deficiency are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Aromatic L-amino acid decarboxylase deficiency?

1 patient support program are currently tracked on UniteRare for Aromatic L-amino acid decarboxylase deficiency. See the treatments and support programs sections for copay assistance, eligibility, and contact details.