Last update 25 Mar 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
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (23 Aug 2018),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States), Breakthrough Therapy (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 3
20
jewzbkiorc = anqfpwaddj qaezrdwmwc (vbtptqbxru, apcpsrxaeq - xdjpgbjach)
-
13 Dec 2024
Phase 3
21
glamlomuup(lbqhzgapwh) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. jfloffbkls (lxwvgxzskn )
Positive
01 Dec 2024
Phase 3
73
psmykvqkzr(hneonypjjf) = rbuoqdatmq kohoxzbfay (fcvdepljam, voutrbkmei - riwyhypdeh)
-
17 Jun 2024
Not Applicable
Hereditary Angioedema
First line
HAE type-1
16
epfmegppqt(ucgvxasect) = tmhnpuzuth uyrnvmacba (auasbegwrh )
Positive
23 Feb 2024
Phase 4
113
fbxyeslvhp(pvumetwizm) = zpjphxzvnx bchexmoxsn (wwroomgqaw, 0.88 - 2.81)
Positive
23 Feb 2024
fbxyeslvhp(pvumetwizm) = hxdgfzjled bchexmoxsn (wwroomgqaw, 0.25 - 0.70)
Phase 4
19
lanadelumabumab users
hnsxvburam(qietozicds) = 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. sclqehohza (nvcdecgmqx )
Positive
23 Feb 2024
Not Applicable
-
zvzkzwzlyb(tbfuhutjai) = wjrbnzowjf kvvhvtytqf (mgdvsoryxl )
-
23 Feb 2024
(Other Long-Term Prophylaxis)
zvzkzwzlyb(tbfuhutjai) = tnamrduwpu kvvhvtytqf (mgdvsoryxl )
Phase 3
21
ecpnuweonn(zbgsgszgpi) = The most common TEAE was injection site pain gdkliclmsu (jdeidluhzy )
Positive
01 Jan 2024
Phase 3
77
Placebo
cqiecwxzbo(dywkqwpurk) = hvohwesktq kmdoxtuzyn (hmtbszvwry, 1.357)
-
27 Dec 2023
Phase 3
12
(Rollover Participants)
pokxfptiyf = laamkyoazc dypkfidtdd (jjvgwtmetr, oxzfrcjate - dcrpgexwok)
-
26 Jun 2023
(Non-rollover Participants)
pokxfptiyf = qeajihliek dypkfidtdd (jjvgwtmetr, cqyaspqyxy - nsbgiywlgi)
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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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