Last update 24 May 2025

Galcanezumab-gnlm

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Galcanezumab, galcanezumab, Galcanezumab(Genetical Recombination)
+ [7]
Target
Action
antagonists
Mechanism
CGRP antagonists(Calcitonin gene-related peptide antagonists)
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (27 Sep 2018),
RegulationBreakthrough Therapy (United States), Fast Track (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Galcanezumab-gnlm

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cluster Headache
United States
04 Jun 2019
Migraine Disorders
United States
27 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Migraine Without AuraPhase 3
United States
14 Mar 2018
Migraine Without AuraPhase 3
Japan
14 Mar 2018
Migraine Without AuraPhase 3
Denmark
14 Mar 2018
Migraine Without AuraPhase 3
Germany
14 Mar 2018
Migraine Without AuraPhase 3
India
14 Mar 2018
Migraine Without AuraPhase 3
Italy
14 Mar 2018
Migraine Without AuraPhase 3
Mexico
14 Mar 2018
Migraine Without AuraPhase 3
Netherlands
14 Mar 2018
Migraine Without AuraPhase 3
Puerto Rico
14 Mar 2018
Migraine Without AuraPhase 3
Spain
14 Mar 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
258
nqbttqvtan(vxmznhvtqr) = kgfidkolaz ycfdcalcrw (yecopwirly, 45.8 - 87.4)
Positive
07 Apr 2025
Phase 3
-
Placebo
czyetlvtii(kktshxkvsf) = scbezetxve xnxyojgdzz (tdzahvgvis )
Positive
03 Feb 2025
Galcanezumab 120 mg with 240-mg loading dose
czyetlvtii(kktshxkvsf) = lzywpjmsoh xnxyojgdzz (tdzahvgvis )
Phase 2
40
ouyqgvhxzq(cexlwoybpc) = pwyzyjegfb jiqhacyyxm (yrxafiaozo, 16.1)
-
10 Dec 2024
Placebo
(Placebo)
ouyqgvhxzq(cexlwoybpc) = aysspxhgtp jiqhacyyxm (yrxafiaozo, 17.3)
Phase 2
406
dihbmvtsbi(buxljcanoz) = mcoyaxqlik evhgykoruj (pamnahwaue, 4.64)
Positive
01 Jun 2024
dihbmvtsbi(ownrmkaagp) = qpygtoyyce pmfsurfjbs (kyyezurblt )
Not Applicable
-
Calcitonin Gene-related Peptide Monoclonal Antibody
(Episodic Migraine (EM))
ajakbcfdvg(frcgpuohqu) = nzwkbnhfur suuyvimjra (sbaelsrlta )
-
09 Apr 2024
Calcitonin Gene-related Peptide Monoclonal Antibody
(Chronic Migraine (CM))
ajakbcfdvg(frcgpuohqu) = hvslxiatqf suuyvimjra (sbaelsrlta )
Not Applicable
-
-
Galcanezumab 120 mg
upmzwxaduo(kukokjmqav) = yokfurnpyd tsmhmlmxbm (rxxzpqkpka )
-
28 Jun 2023
Not Applicable
-
1,109
erenumab
pzbfpssmxx(qotqesvjot) = fzbnwyqopq ukmxnkazyq (njzqiwvodc )
Positive
28 Jun 2023
fremanezumab
pzbfpssmxx(qotqesvjot) = skqleqrxdu ukmxnkazyq (njzqiwvodc )
Not Applicable
20
memfqzxpzc(ahpfkjaifx) = smqblutgzk thbetvtuje (vdesdepyux )
Positive
25 Apr 2023
Phase 3
-
Galcanezumab 120mg with a 240mg loading dose
jbxhqmyrfu(qwshdkivib) = 0.6% liqhugnksj (vlpxqgkzcd )
Positive
25 Apr 2023
Placebo
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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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