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 being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is not approved for any indication and remains in the investigational stage.
DNL151 is being developed by Denali Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker DNLI. The company is conducting clinical research on this small molecule in healthy volunteer populations.
DNL151 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation.
DNL151 has one completed clinical trial, NCT04557800, titled 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers.' This Phase 1 study enrolled 186 participants in the Netherlands and was placebo-controlled, randomized, and double-blind.
DNL151 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy volunteers was designed to assess safety, tolerability, and pharmacokinetics, but the drug has not received marketing approval.