Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DNL628 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Experimental Arm | EXPERIMENTAL | - |
| Placebo Arm | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DNL628 | DRUG | Multiple ascending doses |
| Placebo | DRUG | Multiple ascending doses |
Key Inclusion Criteria: * BMI of ≥18 to \< 32 kg/m2 and body weight of ≥45 kg * Have a diagnosis of probable AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening * Have supportive evidence of AD pathology via historical records or laboratory testing...
DNL628 is an investigational small molecule developed by Denali Therapeutics Inc. (NASDAQ: DNLI) for the treatment of early onset Alzheimer disease. It is designed to target tau, a protein implicated in the disease. DNL628 is currently in Phase 1 clinical development and has not been approved by any regulatory agency.
DNL628 is being developed for the treatment of early onset Alzheimer disease. It is an investigational therapy that targets the tau protein. The Phase 1 trial is evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with early Alzheimer's disease. It is not yet approved for any indication.
DNL628 targets tau, a protein that accumulates in the brains of patients with Alzheimer disease. By targeting tau, the drug aims to interfere with the pathological process of tau aggregation or spread. Tau is a well-established target in Alzheimer's research, and DNL628 is a small molecule designed to engage it.
DNL628 is being developed by Denali Therapeutics Inc., a biotechnology company traded on the Nasdaq under the ticker symbol DNLI. Denali focuses on therapies for neurodegenerative diseases, and DNL628 is part of its pipeline for Alzheimer disease.
DNL628 is in Phase 1 clinical development. The only trial to date is a Phase 1 study that is currently recruiting participants. As an investigational drug, DNL628 has not been approved by the FDA or any other regulatory authority for any indication.
DNL628 is being studied in one Phase 1 clinical trial, NCT07328451, titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease." The trial is currently recruiting and plans to enroll 68 participants in the Netherlands and the United Kingdom.