Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DNL151 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| DNL151 | EXPERIMENTAL | Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (10 days); Part C: Single-dose cohort; Part D: Additional multiple-dose cohort (28 days); Part E Multiple-ascending dose cohorts (14 days) |
| Placebo | PLACEBO_COMPARATOR | Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (10 days); Part C: Single-dose cohort; Part D: Additional multiple-dose cohort (28 days); Part E Multiple-ascending dose cohorts (14 days) |
| Name | Type | Description |
|---|---|---|
| DNL151 | DRUG | oral dose(s) |
| Placebo | DRUG | oral dose(s) |
Key Inclusion Criteria: * Body mass index 18.5 to 35.0 kg/m², inclusive, and body weight of at least 50.0 kg at screening * In good health, determined by no clinically significant findings from medical history, physical examination, and vital sign measurements * Women of non-childbearing potential ...
DNL151 is an investigational small molecule developed by Denali Therapeutics Inc. (ticker: DNLI). It is a Phase 1 clinical-stage candidate studied in healthy volunteers. The specific disease indications for DNL151 have not been disclosed.
DNL151 targets LRRK2, a protein. LRRK2 is a kinase, and DNL151 is designed as a small molecule directed at this protein target. The compound was evaluated in a Phase 1 study that included pharmacokinetic and pharmacodynamic assessments.
DNL151 is being developed by Denali Therapeutics Inc., which trades under the ticker symbol DNLI. Denali is the sponsor of the clinical program for DNL151.
DNL151 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial of DNL151 has been completed, and no trials are currently active.
DNL151 has been studied in one completed Phase 1 trial, NCT04557800, titled a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DNL151 in healthy volunteers. The trial enrolled 186 participants in the Netherlands and was randomized, double-blind, and placebo-controlled.
Yes. The completed Phase 1 trial of DNL151, NCT04557800, enrolled 186 healthy volunteers aged 18 years and older in the Netherlands. The study assessed safety, tolerability, pharmacokinetics, and pharmacodynamics, and it used a randomized, double-blind, placebo-controlled design.