Kisunla

(Donanemab)

ApprovedMonoclonal antibody

Kisunla is a monoclonal antibody that works as Amyloid Beta N3pg Inhibitor.[2] It is being used across 5 indications, with its most advanced program in Approved.[1]

Kisunla is one of 59 monoclonal antibody programs targeting Autosomal Dominant Alzheimers Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Autosomal Dominant Alzheimers DiseaseRecruiting

Early Alzheimer's DiseaseActive, not recruiting

Alzheimer DiseaseActive, not recruiting

Preclinical Alzheimer's DiseaseActive, not recruiting

AmyloidNot yet recruiting

Autosomal Dominant Alzheimers DiseasePreclinical

Recruiting

Early Alzheimer's DiseasePhase 3

Active, not recruiting

Alzheimer DiseasePhase 3

Active, not recruiting

Preclinical Alzheimer's DiseasePhase 3

Active, not recruiting

AmyloidApproved

Not yet recruiting

Competition

Competitive Landscape

100 competitors in Alzheimer Disease

#DrugCompanyPhaseTrials

Leqembi

Eisai

Approved

1 2

Kisunla

Eli Lilly

Approved

4 3

Aleve

Farxiga

Cialis

Rifadin

Epidiolex

Victoza

Avelox

Estrace

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Active, not recruiting

Early Alzheimer's Disease

NCT05738486

Q4 2027

Phase 3Active, not recruiting

Preclinical Alzheimer's Disease

NCT05026866

Q3 2028

Phase 3Active, not recruiting

Alzheimer Disease

NCT05508789

Phase 2Recruiting

Cognitive Dysfunction

NCT07589595

Q4 2028

Phase 3Active, not recruiting

Alzheimer Disease

NCT04437511

Post-ApprovalNot yet recruiting

Amyloid

NCT06911944

Clinical

Trials by Indication[1]

Alzheimer's Disease4 trials

A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT03367403·272 enrolled

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT05108922·148 enrolled

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

Recruiting· Eli Lilly logo

Eli Lilly··NCT06566170·6,250 enrolled

Show 1 more trial

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT04640077·95 enrolled

Alzheimer disease4 trials

Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Active, not recruiting· Biogen logo

Biogen·Phase 3·NCT04437511·1,736 enrolled

A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07571161·140 enrolled

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05508789·1,500 enrolled

Show 1 more trial

An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07602582·550 enrolled

ART2 trials

A Study of Donanemab (LY3002813) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05567159·42 enrolled

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05533411·36 enrolled

Preclinical Alzheimer's Disease2 trials

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05026866·2,996 enrolled

Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1

Enrolling by invitation·PPaul S. Aisen·Phase 2·NCT07167966·450 enrolled

Amyloid1 trial

Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation

Not yet recruiting·—·Phase 4·NCT06911944·60 enrolled

3 more indications

Early Alzheimer's Disease1 trial

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05738486·1,175 enrolled

Cognitive Dysfunction1 trial

A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07589595·350 enrolled

Autosomal Dominant Alzheimers Disease1 trial

A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease

Recruiting·BBanner Health·Preclinical·NCT06996730·240 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 2, 2024

KISUNLA

BLA BLA761248

Jul 2, 2024

KISUNLA

NDA BLA761248

Jul 1, 2025

KISUNLA

NDA BLA761248

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Donanemab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Donanemab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Donanemab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761248). U.S. Food & Drug Administration.
[5]
PubMed — 3 publications indexed for Donanemab. U.S. National Library of Medicine.
[6]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Amyloid Beta N3pg Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Eli Lilly

Key Publications[5]

Safety Profile of Donanemab Versus Lecanemab: Indirect Comparison

Lancet NeurolJan 15, 2024DOI: 10.1016/S1474-4422(24)00012-5

Amyloid Plaque Clearance With Donanemab: Longitudinal Analysis

N Engl J MedSep 5, 2023DOI: 10.1056/NEJMoa2305841

Donanemab in Early Symptomatic Alzheimer Disease: TRAILBLAZER-ALZ 2

JAMAJul 17, 2023DOI: 10.1001/jama.2023.13239

Kisunla

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q3 2028

Q4 2028

Trials by Indication[1]

Alzheimer's Disease4 trials

Alzheimer disease4 trials

ART2 trials

Preclinical Alzheimer's Disease2 trials

Amyloid1 trial

Early Alzheimer's Disease1 trial

Cognitive Dysfunction1 trial

Autosomal Dominant Alzheimers Disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Key Publications[5]

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