Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DNL201 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| DNL201 low dose | EXPERIMENTAL | - |
| DNL201 high dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| DNL201 | EXPERIMENTAL | Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days) |
| Name | Type | Description |
|---|---|---|
| DNL201 | DRUG | Oral repeating dose |
| Placebo | DRUG | Oral repeating dose |
Key Inclusion Criteria: * Body mass index (BMI) between 18 and 35.0 kg/m2, inclusive * Clinical diagnosis of Parkinson's disease meeting UK Brain Bank criteria and H\&Y Stage I, II, or III. * sPD subgroup without a LRRK2 mutation; PD LRRK2 subgroup with LRRK2 mutation * Screening dopamine transport...
DNL201 is an investigational small molecule being studied for Parkinson's disease. It has been evaluated in a Phase 1 clinical trial in subjects with Parkinson's disease and in a separate Phase 1 study in healthy volunteers. DNL201 is not approved and remains in clinical development.
DNL201 is being developed by Denali Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DNLI. Denali conducted the Phase 1 clinical trials of DNL201 in the United States.
DNL201 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in subjects with Parkinson's disease and one in healthy volunteers. DNL201 is investigational and has not been approved by regulatory authorities.
DNL201 has been studied in two completed Phase 1 trials. NCT03710707 evaluated DNL201 in 29 subjects with Parkinson's disease in the United States. NCT04551534 evaluated DNL201 in 122 healthy volunteers in the United States. Both trials are completed.
DNL201 is the sole name provided for this investigational drug. No alternative names have been listed for DNL201 in the clinical trial records. The drug is identified by the name DNL201 in all available information.