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 being developed for the treatment of early onset Alzheimer's disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in participants with early Alzheimer's disease to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.
DNL628 targets tau, a protein that plays a role in Alzheimer's disease pathology. By targeting tau, the drug aims to address a key component of the disease process. This mechanism is being investigated in a Phase 1 clinical trial for early onset Alzheimer's disease.
DNL628 is being developed by Denali Therapeutics Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol DNLI. The company is conducting a Phase 1 clinical trial to evaluate the drug in participants with early Alzheimer's disease.
DNL628 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The ongoing Phase 1 trial is recruiting participants to study the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in early Alzheimer's disease.
DNL628 is being studied in a Phase 1 clinical trial with the identifier NCT07328451. This randomized, double-blind, placebo-controlled study is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of DNL628 in participants with early Alzheimer's disease. The trial is recruiting 68 participants in the Netherlands and the United Kingdom.