Lanadelumab

Summary

Lanadelumab (CHEMBL3545189) is an approved antibody (ATC B06AC05) targeting KLKB1; indicated across 5 conditions including hereditary angioedema and angioedema.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: B06AC05
• Targets: 1 (KLKB1)
• Indications: 5 conditions
• Clinical trials: 19

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3545189
Name	Lanadelumab
Type	Antibody
Max phase	4
ATC	B06AC05

Also known as: DX-2930, Lanadelumab, Lanadelumab (shp643), Lanadelumab flyo, Lanadelumab-flyo, SHP-643, Tak-743, Takhzyro, LANADELUMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
KLKB1	kallikrein B1	Binding	10.05	0%	P03952

Bioactivity

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

Target pathways

Aggregated over 1 target gene(s): KLKB1.

Top Reactome pathways

14 total, by targets touching each:

Pathway	Targets	Genes
Hemostasis	1	KLKB1
R-HSA-140837	1	KLKB1
R-HSA-140877	1	KLKB1
Degradation of the extracellular matrix	1	KLKB1
Extracellular matrix organization	1	KLKB1
Activation of Matrix Metalloproteinases	1	KLKB1
Disease	1	KLKB1
R-HSA-9651496	1	KLKB1
Defective factor XII causes hereditary angioedema	1	KLKB1
Defective SERPING1 causes hereditary angioedema	1	KLKB1
Diseases of hemostasis	1	KLKB1
Regulation of FXIIa and plasma kallikrein activity	1	KLKB1
FXIIa, PKa-dependent activation of coagulation pathway	1	KLKB1
FXIIa activates plasma kallikrein-kinin system	1	KLKB1

Dominant GO biological processes

GO term	Targets
Factor XII activation	1
proteolysis	1
blood coagulation	1
zymogen activation	1
plasminogen activation	1
fibrinolysis	1
positive regulation of fibrinolysis	1
inflammatory response	1
hemostasis	1

Indications & clinical

Indications

5 indications (1 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
hereditary angioedema	4	MONDO:0019623	MONDO:0019623
angioedema	3	MONDO:0010481	EFO:0005532
severe acute respiratory syndrome	3	MONDO:0005091	MONDO:0100096
hypotensive disorder	2	MONDO:0005468	EFO:0005251
injury	1	MONDO:0021178	EFO:0000546

Clinical trials

Total trials: 19.

Phase distribution

Phase	Trials
PHASE3	8
PHASE1	6
Not specified	2
PHASE4	1
PHASE2	1
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06818474	PHASE4	RECRUITING	Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
NCT02741596	PHASE3	COMPLETED	Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
NCT04070326	PHASE3	COMPLETED	A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
NCT04180163	PHASE3	COMPLETED	Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE)
NCT04206605	PHASE3	COMPLETED	A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
NCT04444895	PHASE3	COMPLETED	A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor
NCT04590586	PHASE3	COMPLETED	Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
NCT04687137	PHASE3	COMPLETED	Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema
NCT05460325	PHASE3	COMPLETED	A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)
NCT04278885	PHASE2	UNKNOWN	Lanadelumab in FXII-associated Cold Autoinflammatory Syndrome (FACAS)
NCT04422509	PHASE1/PHASE2	COMPLETED	Lanadelumab for Treatment of COVID-19 Disease
NCT01923207	PHASE1	COMPLETED	A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects
NCT02093923	PHASE1	COMPLETED	A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
NCT03401671	PHASE1	COMPLETED	Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
NCT04460105	PHASE1	WITHDRAWN	Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia
NCT04503603	PHASE1	COMPLETED	A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants
NCT04848272	PHASE1	UNKNOWN	Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
NCT05397431	Not specified	ACTIVE_NOT_RECRUITING	A Survey of Lanadelumab in Participants With Hereditary Angioedema
NCT04583007	Not specified	NO_LONGER_AVAILABLE	Expanded Access for the Prevention of Acute Attacks of 1) Hereditary Angioedema (HAE) in Children and 2) Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH) in Teenagers and Adults

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

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

10 molecules share ≥1 primary target. Top 10 by shared-target count:

Molecule	Source	Status	Shared targets
BEROTRALSTAT	ChEMBL + PubChem	Phase 4 (approved)	KLKB1
AVORALSTAT	ChEMBL	Phase 3	KLKB1
DAREXABAN	ChEMBL	Phase 3	KLKB1
GABEXATE	ChEMBL	Phase 3	KLKB1
MILVEXIAN	ChEMBL	Phase 3	KLKB1
SEBETRALSTAT	ChEMBL	Phase 3	KLKB1
FENIRALSTAT	ChEMBL	Phase 2	KLKB1
GW813893	ChEMBL	Phase 2	KLKB1
LETAXABAN	ChEMBL	Phase 2	KLKB1
Amiloride	PubChem	Approved	KLKB1