About Clinical Trials
Before a therapy can be made available to the general public for the treatment of a specific indication, multiple studies must be conducted. These studies are referred to as clinical trials. Clinical trials involve healthy volunteers and patient volunteers to evaluate the safety and effectiveness of the therapy. Clinical trials are regulated by the FDA in the United States and by similar regulatory agencies worldwide.
Currently, Denali is conducting the following Parkinson’s disease clinical trials to evaluate two LRRK2 inhibitors, DNL201 & DNL151
Study to evaluate the safety, tolerability, pharmacokinetics*, and pharmacodynamics† of multiple oral doses of DNL201 in subjects with Parkinson's disease
Study to evaluate the safety, tolerability, pharmacokinetics*, and pharmacodynamics† of multiple oral doses of DNL151 in subjects with Parkinson's disease
*Pharmacokinetics—how the body processes a drug
† Pharmacodynamics—the effects of a drug on the body
For more information please visit ClinicalTrials.gov
Register to receive the following
Updates on Denali’s Parkinson's disease Clinical Trials
Information about Advances in Parkinson’s disease Research
Information about the link between Genetics and Parkinson’s disease
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 update our policy on Expanded Access
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