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Drug

Lanadelumab

Approved medicine
ClassPlasma kallikrein inhibitorResearchOngoing clinical research

Also known as Takhzyro.

RxNorm2055641ChEMBLCHEMBL3545189ATCB06AC05UNII2372V1TKXK
1
Active clinical trials
Plasma kallikrein
Primary target
6
Regulatory events
Latest activity
beta

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

Label change: LANADELUMAB-FLYO (BLA761090)

Regulatory2026-08-20FDA

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

Indication expansion: LANADELUMAB-FLYO (BLA761090)

Regulatory2023-02-03FDA

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

Supplemental approval: LANADELUMAB-FLYO (BLA761090)

Regulatory2022-02-08FDA

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
ChEMBL ID
CHEMBL3545189
ATC codes
B06AC05
UNII
2372V1TKXK
Primary mechanism
Plasma kallikrein inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Plasma kallikrein
KLKB1 · P03952
INHIBITORPlasma kallikrein inhibitor

Regulatory timeline

6 events

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.

Approval / market entry confirmed across FDA and EMA (2018-08-23 → 2018-11-22)
Earliest approval
2018-08-23
Latest approval
2023-02-03
Authorities
FDA · EMA
Total events
6
fdaU.S. Food and Drug Administration· 5 events
2026-08-20Label change
Label change: LANADELUMAB-FLYO (BLA761090)
Evidence ↗
2023-02-03Indication expansion
Indication expansion: LANADELUMAB-FLYO (BLA761090)
Evidence ↗
2022-02-08Supplemental approval
Supplemental approval: LANADELUMAB-FLYO (BLA761090)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2018-11-22Accelerated approvalMulti-authority
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 ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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
14
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
7
Late-stage (III+)
10
Completed
3
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

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)

CompletedPH IIITakedan=772022

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

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

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)

CompletedPH IIITakedan=772022

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

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
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.