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 being studied in healthy participants. It is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.
DNL919 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 investigational small molecule.
DNL919 is in Phase 1 clinical development. A Phase 1 study in healthy participants has been completed. The drug is investigational and has not been approved for any use.
DNL919 has one completed Phase 1 clinical trial, NCT05450549, which evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in healthy participants. The trial enrolled 47 participants and was conducted in the Netherlands.
DNL919 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy participants. Further clinical development and regulatory review would be required before any approval could be considered.