Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DNL201 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| DNL201 low dose | EXPERIMENTAL | - |
| DNL201 high dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 2 | PHASE3 | Onapgo (SPN-830) |
| Prothena Corp. Plc | PRTA | 3 | PHASE3 | Prasinezumab |
| Denali Therapeutics Inc. | DNLI | 1 | PHASE2 | BIIB122 |
| Bayer | BAYRY | 4 | PHASE3 | bemdaneprocel, AB-1005 |
| Biohaven Ltd. | BHVN | 1 | PHASE2 | BHV-8000 |
| AC Immune SA | ACIU | 2 | PHASE2 | ACI-7104.056 |
| Eli Lilly and Company | LLY | 4 | PHASE1 | LY3884961, LY4006896, LY3962681 |
| Gain Therapeutics, Inc. | GANX | 2 | PHASE2 | GT-02287 |
| Annovis Bio Inc | ANVS | 1 | PHASE2 | Buntanetap |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | ALN-SNCA |
| MeiraGTx Holdings Plc | MGTX | 1 | PHASE1 | AAV-GAD |
| Serina Therapeutics, Inc. | SER | 1 | PHASE1 | SER-252 |
| Ardelyx, Inc. | ARDX | 1 | PHASE2 | Tenapanor |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7568282 |
| Merck & Co., Inc. | MRK | 1 | EARLY_PHASE1 | MK-0947 |
DNL201 is an investigational small molecule developed by Denali Therapeutics Inc. (NASDAQ: DNLI) for Parkinson disease. It is designed to inhibit LRRK2, a protein target relevant to Parkinson disease biology. DNL201 has completed a Phase 1 clinical trial and is not approved for any use.
DNL201 is being developed as a treatment for Parkinson disease. It is an investigational therapy that has been studied in a Phase 1 trial in participants with Parkinson disease. It has not been approved by the FDA, and its use remains limited to clinical research at this stage.
DNL201 targets LRRK2, a protein. LRRK2 inhibition is the mechanism under investigation for this small molecule in Parkinson disease. Denali Therapeutics designed DNL201 to modulate LRRK2 activity, and the Phase 1 program enrolled biomarker-selected participants, meaning trial eligibility was tied to a specific biomarker.
DNL201 is developed by Denali Therapeutics Inc., which trades on Nasdaq under the ticker DNLI. Denali is a biopharmaceutical company focused on therapies for neurodegenerative diseases, and DNL201 is one of its clinical-stage assets in neurology.
DNL201 is in Phase 1. Its single registered clinical trial, NCT03710707, has been completed. The study was randomized, double-blind, and placebo-controlled, and it enrolled 29 participants with Parkinson disease in the United States. DNL201 is investigational and has not been approved by the FDA.
DNL201 has been studied in one clinical trial, NCT03710707, titled Study to Evaluate DNL201 in Subjects With Parkinson's Disease. That Phase 1 trial is completed, enrolled 29 participants, and was conducted in the United States. It was randomized, double-blind, and placebo-controlled, and enrolled adults aged 30 years and older.