DNL628 / Denali Therap - LARVOL DELTA

DNL628 (OTV:MAPT) for Alzheimer's disease (GlobeNewswire) - "In March 2026, the first patient was dosed in the Phase 1b study of DNL628, which is an investigational therapy for Alzheimer’s disease and enabled by Denali’s Oligonucleotide TransportVehicle (OTV). DNL628 is designed to cross the BBB and reduce the tau protein by targeting the MAPT gene that encodes for tau. Denali expects data from this study in 1H 2027."

P1 data • Trial status • 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 | 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