Drug

Lanadelumab

Approved · EMA

Late-stage development

Also known as Takhzyro.

RxNorm2055641UNII2372V1TKXK

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein

Clinical trial2026-06-29Results posted · ClinicalTrials.gov

Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

Clinical trial2025-02-25Results expected Q3 2027 · ClinicalTrials.gov

Factor XII-associated Cold Autoinflammatory Syndrome (FACAS) Linked to Kallikrein-kinin Pathology: Proof of Concept Treatment With Lanadelumab (DX-2930)

Clinical trial2024-12-31Primary completion · ClinicalTrials.gov

A Multi-center, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Lanadelumab (SHP643) in Chinese Subjects With Hereditary Angioedema

Clinical trial2024-12-13Results posted · ClinicalTrials.gov

Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

Clinical trial2024-06-17Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

Clinical trial2023-12-27Results posted · ClinicalTrials.gov

A Phase 3 Multi-center, Open-label Study to Evaluate the Efficacy and Safety of Lanadelumab (SHP643) in Japanese Subjects With Hereditary Angioedema

Clinical trial2022-09-30Results posted · ClinicalTrials.gov

Industry Alliance Platform Trial to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

Clinical trial2022-06-29Results posted · ClinicalTrials.gov

SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age

Clinical trial2022-05-26Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Subjects

Clinical trial2022-03-07Results posted · ClinicalTrials.gov

Accelerated approval: Takhzyro (EMA)

Regulatory2018-11-22EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Lanadelumab

Aliases & brands

Takhzyro

RxNorm CUI

2055641

UNII

2372V1TKXK

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2018-11-22

Latest approval

2018-11-22

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2018-11-22Accelerated approval

Accelerated approval: Takhzyro (EMA)

Indication: Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2024

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 14

Phase 14Phase 1 / 21Phase 22Phase 36Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

RecruitingPH IVBernstein Clinical Research Centern=52027

A Multi-center, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Lanadelumab (SHP643) in Chinese Subjects With Hereditary Angioedema

CompletedPH IIITakedan=202023

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

CompletedPH IIIShiren=732023

CompletedPH IIITakedan=772022

CompletedPH IIIShiren=212021

Recent completions

Trials that read out recently, adding to the completed evidence base.

Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein

CompletedPH IIVanderbilt University Medical Centern=282024

A Multi-center, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Lanadelumab (SHP643) in Chinese Subjects With Hereditary Angioedema

CompletedPH IIITakedan=202023

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

CompletedPH IIIShiren=732023

CompletedPH IIITakedan=772022

CompletedPH IIIShiren=212021

A Phase 3 Multi-center, Open-label Study to Evaluate the Efficacy and Safety of Lanadelumab (SHP643) in Japanese Subjects With Hereditary Angioedema

CompletedPH IIIShiren=122021

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.