DNL628 / Denali Therap - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Denali Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

Denali today announced that the Clinical Trial Application (CTA) for the Phase 1b study of DNL628 has been approved and study start-up activities are underway. (GlobeNewswire)

New trial • Alzheimer's Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1 | N=68 | Not yet recruiting | Sponsor: Denali Therapeutics Inc.

New P1 trial • Alzheimer's Disease • CNS Disorders

DNL628 (OTV:MAPT) for the treatment of Alzheimer's disease (GlobeNewswire) - "In October, the company submitted a Clinical Trial Application (CTA) for DNL628 (OTV:MAPT) to initiate clinical studies in Alzheimer’s disease, marking a significant milestone in advancing the Oligonucleotide TransportVehicle (OTV) platform." "

New trial • Alzheimer's Disease

Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights (GlobeNewswire) - "Denali expects to submit regulatory applications to begin clinical testing of one to two TV-enabled programs each year over the next three years across its Enzyme TV (ETV), Antibody TV (ATV), and Oligonucleotide TV (OTV) franchises. The most advanced programs include:...DNL111 (ETV:GCase) for Parkinson’s/Gaucher disease;...DNL921 (ATV:Abeta) for Alzheimer’s disease; DNL628 (OTV:MAPT) for Alzheimer’s disease; and DNL422 (OTV:SNCA) for Parkinson’s disease."

IND • Alzheimer's Disease • Parkinson's Disease