Donanemab

Summary

Donanemab (CHEMBL4297245) is an approved antibody (ATC N06DX05); indicated across 2 conditions including alzheimer disease and dementia.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: N06DX05
• Indications: 2 conditions
• Clinical trials: 17

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297245
Name	Donanemab
Type	Antibody
Max phase	4
ATC	N06DX05

Also known as: Donanemab, Donanemab-azbt, Kisunla, LY 3002813, LY-3002813, LY3002813, DONANEMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
Alzheimer disease	4	MONDO:0004975	MONDO:0004975
dementia	4	MONDO:0001627	HP:0000726

Clinical trials

Total trials: 17.

Phase distribution

Phase	Trials
PHASE3	7
PHASE2	4
PHASE1	3
PHASE4	1
PHASE2/PHASE3	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06911944	PHASE4	NOT_YET_RECRUITING	Amyloid Lowering for Alzheimer’s in Down’s With Donanemab Investigation
NCT04437511	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Donanemab (LY3002813) in Participants With Early Alzheimer’s Disease (TRAILBLAZER-ALZ 2)
NCT05026866	PHASE3	ACTIVE_NOT_RECRUITING	A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer’s Disease (TRAILBLAZER-ALZ 3)
NCT05508789	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer’s Disease (TRAILBLAZER-ALZ 5)
NCT05738486	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer’s Disease (TRAILBLAZER-ALZ 6)
NCT06996730	PHASE2/PHASE3	NOT_YET_RECRUITING	A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer’s Disease
NCT07571161	PHASE3	NOT_YET_RECRUITING	Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer’s Disease
NCT07602582	PHASE3	NOT_YET_RECRUITING	A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
NCT05108922	PHASE3	COMPLETED	A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer’s Disease (TRAILBLAZER-ALZ 4)
NCT07167966	PHASE2	NOT_YET_RECRUITING	Alzheimer’s Tau Platform: Regimen A - AADvac1
NCT07589595	PHASE2	NOT_YET_RECRUITING	A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
NCT03367403	PHASE2	COMPLETED	A Study of LY3002813 in Participants With Early Symptomatic Alzheimer’s Disease (TRAILBLAZER-ALZ)
NCT04640077	PHASE2	COMPLETED	A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer’s Disease (TRAILBLAZER-EXT)
NCT02624778	PHASE1	COMPLETED	A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer’s Disease (AD) or AD
NCT05533411	PHASE1	COMPLETED	A Study of Donanemab (LY3002813) in Healthy Chinese Participants
NCT05567159	PHASE1	COMPLETED	A Study of Donanemab (LY3002813) in Healthy Participants
NCT06566170	Not specified	RECRUITING	A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer’s Disease

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).