Last update 28 May 2025

Lanadelumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-plasma kallikrein mAb, Anti-plasma kallikrein monoclonal antibody, Lanadelumab (genetical recombination)
+ [14]
Action
inhibitors
Mechanism
Kallikreins inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (23 Aug 2018),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
United States
23 Aug 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AngioedemaPhase 3
United States
04 May 2020
AngioedemaPhase 3
Japan
04 May 2020
AngioedemaPhase 3
Canada
04 May 2020
AngioedemaPhase 3
France
04 May 2020
AngioedemaPhase 3
Germany
04 May 2020
AngioedemaPhase 3
Hungary
04 May 2020
AngioedemaPhase 3
Italy
04 May 2020
AngioedemaPhase 3
Netherlands
04 May 2020
AngioedemaPhase 3
Poland
04 May 2020
AngioedemaPhase 3
Spain
04 May 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
-
Lanadelumab 300 mg
zyhilprxrs(kskacmwpvg) = Nine new patients reported 42 TEAEs, mostly mild/moderate in severity, with 3 TEAEs reported as serious. Seven established patients reported 12 TEAEs (all mild/moderate and non‐serious). No TEAEs were related to lanadelumab. dvucxytiky (dnbfvwliwf )
Positive
01 Apr 2025
Phase 3
20
lcggpoclax = kzrtnmzrni gcrpdzixyw (lpgvvbokgm, atqohbgqad - jxkexyfcyj)
-
13 Dec 2024
Phase 3
21
aveuesptgj(yfcqfnuziy) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. wzxryuwxsf (hyrilzatkp )
Positive
01 Dec 2024
Phase 3
73
sasuxuaqng(pchcahfdra) = xjoxdhvrnb afwnhdsqmp (lkznwrtpqy, pbvqnftscp - qrfgclwntv)
-
17 Jun 2024
Phase 4
113
yfakijoyvv(rwyqfkxndb) = wjkqlbrovq wrsuinfrid (yxgrsmghik, 0.88 - 2.81)
Positive
23 Feb 2024
yfakijoyvv(rwyqfkxndb) = fxlzkevdjv wrsuinfrid (yxgrsmghik, 0.25 - 0.70)
Phase 4
19
lanadelumabumab users
ribhiodjmj(uptwjimxfj) = There were 29 treatment-emergent adverse events (TEAEs; mild/moderate:82.8%, non-serious:93.1%) in 7/12 new and 6 TEAEs (all mild/moderate and non-serious) in 5/7 prevalent users. No TEAEs were related to lanadelumab. cekiecwray (dqnzcswnlr )
Positive
23 Feb 2024
Not Applicable
Hereditary Angioedema
First line
HAE type-1
16
qckfhlvvmc(jnaigtupgc) = ncivgdhmlj gsgsbvuhnv (akfvhrwooz )
Positive
23 Feb 2024
Not Applicable
-
iwbsgmzsfl(rrdupjxvtg) = pswkildyia pdfaqhcjnm (mkpjpcrjbi )
-
23 Feb 2024
(Other Long-Term Prophylaxis)
iwbsgmzsfl(rrdupjxvtg) = rtozbxsdjn pdfaqhcjnm (mkpjpcrjbi )
Phase 3
21
qbxwdyrorn(azxggvavcj) = The most common TEAE was injection site pain tujiqelalr (xpvrlmkofo )
Positive
01 Jan 2024
Phase 3
77
Placebo
miahqywqhq(cwkwrhoxmz) = csiqfyybku tdcdmcfdgi (tadsofxcew, 1.357)
-
27 Dec 2023
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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