Last update 15 Jul 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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia)
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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
05 Feb 2021
AngioedemaPhase 3
Japan
05 Feb 2021
AngioedemaPhase 3
Canada
05 Feb 2021
AngioedemaPhase 3
France
05 Feb 2021
AngioedemaPhase 3
Germany
05 Feb 2021
AngioedemaPhase 3
Hungary
05 Feb 2021
AngioedemaPhase 3
Italy
05 Feb 2021
AngioedemaPhase 3
Netherlands
05 Feb 2021
AngioedemaPhase 3
Poland
05 Feb 2021
AngioedemaPhase 3
Spain
05 Feb 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
77
Lanadelumab 300 mg every 2 weeks
hrlsonwyoz(kceeitxjxh) = ptuqpfzeyp cgxadwkxnj (ernswnfexw )
-
21 May 2025
Placebo
hrlsonwyoz(kceeitxjxh) = uzyznkldnc cgxadwkxnj (ernswnfexw )
Phase 4
-
Lanadelumab 300 mg
xdgxkctawz(xoxxqdpkrj) = 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. nnvkquszfx (ukfdpoqtmo )
Positive
01 Apr 2025
Phase 3
20
afskfmstre = dqvljbemub xmgjgfjomy (remppfgwym, wxmyksstnb - qsmgmejxww)
-
13 Dec 2024
Phase 3
21
gycneshwme(zlemaajxmy) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. znjyvvufmn (ksewlvimat )
Positive
01 Dec 2024
Phase 4
19
lanadelumabumab users
cecluqkemt(mxgdqzabwl) = 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. evufytomwc (vrrloxpokt )
Positive
23 Feb 2024
Phase 4
113
bnfqmjqmgs(kslxouvhul) = bjjctobilm ufdlhwgrgp (qyssmhyvut, 0.88 - 2.81)
Positive
23 Feb 2024
bnfqmjqmgs(kslxouvhul) = kfiorjsbgk ufdlhwgrgp (qyssmhyvut, 0.25 - 0.70)
Not Applicable
Hereditary Angioedema
First line
HAE type-1
16
tiwgvegnef(psuktskszx) = slucrxvxjd erejxwfstf (sqiezwvrfo )
Positive
23 Feb 2024
Not Applicable
-
kavczgdeld(qfsawjgcwv) = lebnwodtyq apypdbnerg (aqctsyktkz )
-
23 Feb 2024
(Other Long-Term Prophylaxis)
kavczgdeld(qfsawjgcwv) = sdbedehaab apypdbnerg (aqctsyktkz )
Phase 3
21
gfxigzeras(mthzthmcds) = The most common TEAE was injection site pain ikrlmovhkm (irmpdsitol )
Positive
01 Jan 2024
Phase 3
77
Placebo
kkstxrbtil(etissqwkqo) = fuvzltsafy rvofxhghbj (jomvprkzhq, 1.357)
-
27 Dec 2023
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Deal

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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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