Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DNL919 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| DNL919 (Healthy Participant) | EXPERIMENTAL | - |
| Placebo (Healthy Participant) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DNL919 | DRUG | Single doses |
| Placebo | DRUG | Single doses |
Key Inclusion Criteria: * Female participants of non-childbearing potential (surgically sterilized or post menopausal) or male participants, aged 18 to 55 years, inclusive * BMI 18.5 to \<30 kg/m² * When engaging in sex with a woman of child bearing potential, both the male participant and his fema...
DNL919 is an investigational small molecule developed by Denali Therapeutics Inc. (NASDAQ: DNLI) that targets TREM2. It has been studied in a Phase 1 clinical trial in healthy participants. The specific diseases or indications it may treat have not been disclosed.
DNL919 targets TREM2, a protein that acts as a receptor on certain immune cells. By binding to TREM2, the small molecule is designed to modulate TREM2 activity. Denali Therapeutics is developing DNL919 as an investigational agent based on this mechanism.
DNL919 is being developed by Denali Therapeutics Inc., a biotechnology company that trades on the Nasdaq under the ticker symbol DNLI. Denali is the sponsor of the clinical program evaluating DNL919.
DNL919 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 study of DNL919 has been completed, and no active trials of the drug are currently listed.
DNL919 has been evaluated in one Phase 1 clinical trial, NCT05450549, titled a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DNL919 in healthy participants. The trial enrolled 47 participants in the Netherlands, was randomized, double-blind, and placebo-controlled, and is now completed.