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Metabolic & Lysosomal

Urea Cycle Disorders (UCD) Clinical Trials and Treatments

Also called UCD, Hyperammonemia, OTC Deficiency, CPS1 Deficiency

Urea Cycle Disorders result from mutations in genes encoding any of the eight enzymes or transporter proteins in the urea cycle: carbamoyl phosphate synthetase 1 (CPS1), ornithine transcarbamylase (OTC), carbamoyl phosphate synthetase 2 (CPS2), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginanase (ARG1), and the mitochondrial ornithine transporter 1 (ORNT1). Each enzyme catalyzes sequential steps in the conversion of ammonia and CO2 to urea.

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About Urea Cycle Disorders

Urea Cycle Disorders result from mutations in genes encoding any of the eight enzymes or transporter proteins in the urea cycle: carbamoyl phosphate synthetase 1 (CPS1), ornithine transcarbamylase (OTC), carbamoyl phosphate synthetase 2 (CPS2), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginanase (ARG1), and the mitochondrial ornithine transporter 1 (ORNT1). Each enzyme catalyzes sequential steps in the conversion of ammonia and CO2 to urea. Enzyme deficiency prevents ammonia disposal, leading to hyperammonemia with toxic effects on the CNS.

Neonatal-onset UCDs present in the first few days to weeks of life with poor feeding, vomiting, lethargy, and rapid progression to coma, seizures, and potentially death if untreated. Late-onset forms manifest with intermittent hyperammonemic crises triggered by infections, surgery, stress, or dietary protein intake. Symptoms include confusion, behavioral changes, ataxia, seizures, and encephalopathy. Chronic manifestations include developmental delay, intellectual disability, behavioral problems, and attention deficit. Chronic hyperammonemia even at modest elevations can impair cognitive function and development. Treatment involves ammonia-lowering medications (sodium phenylbutyrate, glycerol phenylbutyrate), protein restriction, supplementation with ammonia-scavenging amino acids, and management of precipitating factors.

Common Symptoms of Urea Cycle Disorders

Recognizing the signs of Urea Cycle Disorders early can lead to faster diagnosis and better outcomes. Symptoms may vary in severity from person to person. If you or a loved one are experiencing any of the following, consider speaking with a specialist.

  • Neonatal presentation: poor feeding, vomiting, lethargy progressing to coma
  • Hyperammonemic crisis: acute neurological deterioration, confusion, seizures
  • Protein intolerance and aversion to high-protein foods
  • Developmental delay and intellectual disability if untreated
  • Behavioral problems and attention difficulties
  • Loss of consciousness and encephalopathy in acute crises

Who Urea Cycle Disorders Affects

Neonatal-onset forms present in first days to weeks of life. Late-onset forms may not manifest until months or years after birth, triggered by illness, stress, or protein ingestion. OTC deficiency shows X-linked inheritance primarily affecting males; other forms show autosomal recessive inheritance. Heterozygous females may be symptomatic. All populations affected.

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Status as each foundation showed it on September 28, 2026.

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Trusted Urea Cycle Disorders Resources

Reputable organizations and medical references for learning more about Urea Cycle Disorders, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for Urea Cycle Disorders

Use this Urea Cycle Disorders clinical trial finder to see the 17 studies recruiting patients and 5 opening soon in the United States and worldwide, with eligibility criteria in plain English. These studies play a critical role in advancing care for metabolic & lysosomal conditions and may offer access to treatments not yet widely available. Each trial below is sourced directly from ClinicalTrials.gov, with eligibility criteria translated into plain English to help patients and caregivers evaluate whether a study may be a fit.

TrialsSite mapPipeline timeline

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

22 active trials worldwide
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RECRUITINGRecently updatedNCT05299710

Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)

Intervention: Laparoscopic surgery

Sponsor: Erin Rowell

The purpose of this study is to safely remove ovarian tissue in pre-pubertal pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.

Ages up to 11 Years1 location
Started May 2018Updated 3 weeks agoEst. Dec 2030 (~4y 3m)
RECRUITINGRecently updatedNCT06805695

Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)

Intervention: No Intervention

Sponsor: iECURE, Inc.

This LTFU is being conducted to assess long-term safety and durability of response in participants dosed with IP in a parent protocol, and to collect longitudinal natural history in enrolled but not dosed participants who also participated in a parent protocol.

Ages 7 Months – 15 Months3 locations
Started Dec 2024Updated 4 weeks agoEst. Jul 2041 (~14y 10m)
RECRUITINGPHASE1, PHASE2Recently updatedNCT07667387

Study of LNP.UCD.ABE in Patients With Urea Cycle Disorders

Intervention: LNP.UCD.ABE

Sponsor: Rebecca Ahrens-Nicklas

This is a single-site Phase 1/2 open-label umbrella clinical trial designed to evaluate the safety, tolerability, and efficacy of a single intravenous dose of LNP.UCD.ABE in 5 pediatric subjects with severe infantile-onset UCDs. This is a master clinical protocol in which subject...

Ages 24 Hours – 5 Years1 location
Started Aug 2026Updated 1 month agoEst. Sep 2028 (~2 years)
NOT YET RECRUITINGPHASE1, PHASE2Recently updatedNCT07773246

Phase 1/2 Study of KRRO-121 in Healthy Volunteers and Patients With UCD

Intervention: KRRO-121, Placebo

Sponsor: Korro Bio, Inc.

Phase 1/2 Study of KRRO-121 is a randomized, placebo-controlled study in Healthy Volunteers (Phase 1 SAD and MAD) and Study Participants with Urea Cycle Disorders (Phase 2). The primary objective of the study is to evaluate the safety of KRRO-121.

Ages 18 Years – 65 Years1 location
Started Sep 2026Updated 1 month agoEst. Aug 2027 (~11 months)
RECRUITINGPHASE3Recently updatedNCT06255782

An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency

Intervention: ECUR-506

Sponsor: iECURE, Inc.

Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia. Individuals with OTC deficiency can develop elevated levels of ammonia in the ...

Ages 24 Hours – 7 Months12 locations
Started Apr 2024Updated 1 month agoEst. Dec 2027 (~1y 3m)
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Active trial locations18 cities in the US
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Trial Pipeline

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Related Metabolic & Lysosomal Conditions

Other rare diseases in the metabolic & lysosomal category. Patients with Urea Cycle Disorders may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Companies Developing Urea Cycle Disorders Treatments

6 pharmaceutical companies have Urea Cycle Disorders in their rare disease portfolio

Frequently Asked Questions About Urea Cycle Disorders