Clinical Trials

Denali's Hunter Syndrome Clinical Trials

A Phase 2/3 Efficacy and Safety Study of DNL310 in Pediatric Participants with Neuronopathic or Non-Neuronopathic Hunter Syndrome

A Phase 2/3, double-blind, randomized study to determine the efficacy and safety of DNL310 compared with idursulfase in pediatric participants with neuronopathic and non-neuronopathic MPS II. For every two study participants randomized to receive DNL310, one will receive idursulfase. This study will be conducted at multiple sites globally.

Study Status: This study is currently recruiting participants. For additional information, please view details on ClinicalTrials.gov

A Study of DNL310 in Pediatric Subjects with Hunter Syndrome

A Phase 1/2 study of DNL310 for pediatric patients with Hunter syndrome (MPS II). The study includes a 24-week dose escalation phase with an 18-month safety extension and will be conducted at multiple sites.

Study Status: This study is currently recruiting participants. For additional information, please view details on ClinicalTrials.gov

A Study of Potential Biomarkers in Hunter Syndrome

A non-treatment observational study of biomarkers in patients with Hunter syndrome (MPS II). The study will be conducted for 18 months in the United States and Europe.

Study Status: This study is currently recruiting participants. For additional information, please view details on ClinicalTrials.gov

Register To Stay Informed

DNL310 is an investigational drug and is not approved by any Health Authority

Policy On Expanded Access To Investigational Drugs

Denali understands that there are some cases when a patient is unable to participate in a clinical trial, and other treatment options have been exhausted. In those cases the patient’s physician may choose to request access to an investigational drug outside of a clinical trial via what is termed Expanded Access in the United States.

Currently, participation in clinical trials is the only way for patients to gain access to Denali’s investigational therapies. As more clinical data on the safety and efficacy of these investigational therapies become available, we will review and may update our policy on Expanded Access.