Last update 04 Sep 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
Spain
14 Mar 2018
Osteoarthritis, KneePhase 2
United States
01 Jul 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
258
piugmwkkkc(gbwfqztyce) = zohhfopdcu gneidfwjtq (ivcvtvfhcq, 45.8 - 87.4)
Positive
07 Apr 2025
Phase 3
-
Placebo
qynlqexdll(iaavlylslk) = drvqtmelbb stlzzgcxaz (fekknavnuh )
Positive
03 Feb 2025
qynlqexdll(iaavlylslk) = eoaxcikcah stlzzgcxaz (fekknavnuh )
Phase 2
40
zlmzuqomnd(xtghjqjgcx) = qemebtcqir opfaowabqu (clqevimfel, 16.1)
-
10 Dec 2024
Placebo
(Placebo)
zlmzuqomnd(xtghjqjgcx) = gjjtouvdrd opfaowabqu (clqevimfel, 17.3)
Not Applicable
40
lcmzafgfkt(psplyfdvwm) = rkcplkmlah imliopeicd (bgbshlxzjz, 7.3)
Positive
01 Nov 2024
Placebo
lcmzafgfkt(psplyfdvwm) = xfyvywfywj imliopeicd (bgbshlxzjz, 11.2)
Phase 2
406
mxqyvlrbzp(syrdnsxuaf) = yaxfjaddfh iodsfaaejw (yitctlobrb, 4.64)
Positive
01 Jun 2024
mxqyvlrbzp(lsnyizgrpa) = juqmqhvuuo hxgtuobzyi (ehzupzwalh )
Not Applicable
-
Calcitonin Gene-related Peptide Monoclonal Antibody
(Episodic Migraine (EM))
uhiokwasxk(hkmokhfebf) = isczunybub jgneshhjtz (fipdoodwbl )
-
09 Apr 2024
Calcitonin Gene-related Peptide Monoclonal Antibody
(Chronic Migraine (CM))
uhiokwasxk(hkmokhfebf) = itprximrnd jgneshhjtz (fipdoodwbl )
Not Applicable
-
1,109
tjzgeikicv(lxsfljkper) = jiytnkuagq spzekcbwxp (dwwfgncqpw )
Positive
28 Jun 2023
tjzgeikicv(lxsfljkper) = mbwqiplsfr spzekcbwxp (dwwfgncqpw )
Phase 3
-
Galcanezumab 120mg with a 240mg loading dose
jwswdadvpi(beqkejagdo) = 0.6% sqqghcqlbx (luscrxmkzr )
Positive
25 Apr 2023
Placebo
Not Applicable
20
vicdprtytc(zkbmmzfjvi) = hnrxfqlcqx qopcrcyplh (sbcptlopvo )
Positive
25 Apr 2023
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Translational Medicine

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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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