Recent Updates
Recently added Catalysts

DNL921

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Denali Therapeutics Inc.|Last Updated: Aug 20, 2026

Target and mechanism

Molecular targetAbeta
Target classProtein
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment178

FDA Designations

No designations recorded

Clinical trial landscape

DNL921 · 1 trial · 2 indications

Phase 1 1
NCT07758595A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's DiseaseAlzheimer's Disease
RECRUITING178 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Incidence and severity of treatment-emergent averse events (TEAEs)
46 days
Parts B and C: Incidence and severity of TEAEs in participants with AD
242 days

Secondary Endpoints

PK Parameter: Maximum concentration (Cmax) of DNL921 in serum
Up to 242 Days
PK Parameter: Time to reach maximum concentration (tmax) of DNL921 in serum
Up to 242 Days
PK Parameter: Area under the concentration-time curve (AUC) from time zero to time of last measurable concentration (AUClast) of DNL921 in serum
Up to 242 Days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental ArmEXPERIMENTAL -
Placebo ArmPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DNL921DRUGSingle or multiple doses
PlaceboDRUGSingle or multiple doses matched to experimental treatment
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria (Healthy Participants): * Are male or female of non-childbearing potential and are aged 18 through 60 years at the time of screening * Have a BMI of 18 through 32 kg/m2 and a body weight of at least 50 kg * For female participants: Are of non-childbearing potential * For male...

Countries:United Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07758595Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07758595Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 11, 2026NCT07758595NEW_TRIAL: changed
LOWAug 11, 2026NCT07758595NEW_TRIAL: changed

Frequently asked questions about DNL921

What is DNL921 used for in Alzheimer's Disease?

DNL921 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy participants and in people with Alzheimer's Disease to evaluate its safety, pharmacokinetics, and pharmacodynamics.

What does DNL921 target?

DNL921 targets Abeta, a protein that forms amyloid plaques in the brain, which are a hallmark of Alzheimer's Disease. By targeting this protein, the drug aims to address a key pathological feature of the disease. The drug is a small molecule designed to interact with this target.

Who makes DNL921?

DNL921 is being developed by Denali Therapeutics Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DNLI. The company is conducting a Phase 1 clinical trial of DNL921 in the United Kingdom, which is currently recruiting participants.

What phase is DNL921 in?

DNL921 is in Phase 1 clinical development. The drug is investigational and has not been approved by the FDA or any other regulatory agency. It is being studied in a single Phase 1 trial that is currently recruiting participants, with an enrollment target of 178 individuals.

What clinical trials is DNL921 in?

DNL921 is being studied in a Phase 1 clinical trial with the identifier NCT07758595. The trial is titled 'A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease.' It is a randomized, double-blind, placebo-controlled study conducted in the United Kingdom.

Is DNL921 the same as any other drug?

DNL921 is a unique investigational drug candidate developed by Denali Therapeutics Inc. It is not known to be the same as any other approved or investigational medication. The drug is being evaluated specifically for its potential role in treating Alzheimer's Disease by targeting the Abeta protein.