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DNL747 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| DNL747 First, Placebo Second | EXPERIMENTAL | Subjects will receive DNL747 for 29 days for the first period and then will switch to placebo for 29 days for the second period. There will be a 14-day washout period between the 2 treatment periods. |
| Placebo First, DNL747 Second | EXPERIMENTAL | Subjects will receive placebo for 29 days for the first period and then will switch to DNL747 for 29 days for the second period. There will be a 14-day washout period between the 2 treatment periods. |
| Name | Type | Description |
|---|---|---|
| DNL747 | DRUG | DNL747 |
| Placebo | DRUG | Placebo |
Key Inclusion Criteria: * Women of non-childbearing potential and men, aged 55-85 years * AD diagnosis based on the 2011 National Institute on Aging-Alzheimer's Association Guidelines * Supportive evidence for diagnosis of AD based upon positive CSF Aβ42 test, or documented history of positive amyl...
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DNL747 is an investigational small molecule developed by Denali Therapeutics Inc. (ticker DNLI) for Alzheimer disease. It is a Phase 1 clinical-stage candidate in the neurology therapeutic area. DNL747 has been studied in a single completed Phase 1 trial and is not approved for any use.
DNL747 targets RIPK1, a protein involved in inflammatory and cell death signaling. RIPK1 is the molecular target of this small molecule. Denali Therapeutics designed DNL747 to inhibit RIPK1 as a potential approach in Alzheimer disease, though the drug remains in early clinical development.
DNL747 is made by Denali Therapeutics Inc., a biotechnology company that trades under the ticker symbol DNLI. Denali is developing DNL747 as a small molecule RIPK1 inhibitor for Alzheimer disease and has completed one Phase 1 clinical trial of the candidate.
DNL747 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The only recorded trial of DNL747 is a completed Phase 1 study, and no active trials of the drug are currently listed.
DNL747 has been evaluated in one clinical trial, NCT03757325, titled "Study to Evaluate DNL747 in Subjects With Alzheimer's Disease." This Phase 1 trial was completed, enrolled 16 participants, was randomized, double-blind, and controlled, and was conducted in the United States and the Netherlands.
The Phase 1 trial NCT03757325 enrolled 16 participants with Alzheimer disease. Eligible subjects were 55 years of age or older, of all sexes, and healthy volunteers were not included. The study was randomized, double-blind, and controlled, and it has been completed.