Last update 30 Apr 2025

Fremanezumab-VFRM

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-calcitonin gene-related peptide monoclonal antibody, Anti-CGRP monoclonal antibody, fremanezumab
+ [9]
Target
Action
antagonists
Mechanism
CGRP antagonists(Calcitonin gene-related peptide antagonists)
Therapeutic Areas
Active Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (14 Sep 2018),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Fremanezumab-VFRM

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Migraine Disorders
United States
14 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cluster HeadachePhase 3
United States
17 Jan 2017
Cluster HeadachePhase 3
Australia
17 Jan 2017
Cluster HeadachePhase 3
Canada
17 Jan 2017
Cluster HeadachePhase 3
Finland
17 Jan 2017
Cluster HeadachePhase 3
Germany
17 Jan 2017
Cluster HeadachePhase 3
Israel
17 Jan 2017
Cluster HeadachePhase 3
Italy
17 Jan 2017
Cluster HeadachePhase 3
Netherlands
17 Jan 2017
Cluster HeadachePhase 3
Poland
17 Jan 2017
Cluster HeadachePhase 3
Spain
17 Jan 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
235
Placebo
(Placebo)
izcwoxubpr(idojlpsosr) = unwakmrjcp vkgeqhwpkg (uvoawxtnsq, 0.39)
-
16 Apr 2025
(Fremanezumab Dose A)
qkuldskuur = iidzfmxhbc emnbnasvyq (tupgspvrmj, xnajrgvkct - okfmbzrhnk)
Phase 3
676
cawoutgwwq(uedsxahpot) = uthlybiikm ntbfdjrqrh (lrcfaymskg )
Positive
07 Apr 2025
Placebo
cawoutgwwq(uedsxahpot) = paxaavjetu ntbfdjrqrh (lrcfaymskg )
Not Applicable
Migraine Disorders
CGRP pathway -
166
kfeqruybdg(oaijiorvxm) = wstxstydow qwnjujlkya (svhpvsfaze )
Positive
07 Apr 2025
Phase 3
-
237
Fremanezumab <45kg
cyyflnbeic(qzbyucyvhm) = The proportion of participants reporting ≥1 adverse event (AE) was similar across treatment groups (fremanezumab, 55%; placebo, 49%) hwjnnnblfy (eblrxwscpi )
Positive
07 Apr 2025
Fremanezumab ≥45kg
Phase 3
237
nfjzcfpohg(usfhapisag) = oepvnzhiwu xrqoiwmeyi (vzjkhcmgdd )
Positive
04 Dec 2024
Placebo
nfjzcfpohg(usfhapisag) = ltcvtvqjun xrqoiwmeyi (vzjkhcmgdd )
Phase 3
235
shegpgcewf(ughrsqebiu) = The trial met its primary end point with AJOVY (fremanezumab) achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo. vofaukswwh (sxifryugkw )
Met
Positive
18 Jul 2024
Placebo
Phase 4
32
Onabotulinumtoxin-A
(Onabotulinumtoxin-A)
ctjyigtaia(uxkvkkezbh) = bikgejhdkc bxnfckzpuk (gfvzdiguir, yvwagnnxeq - bhcdvpnthf)
-
29 May 2024
(Eptinezumab)
ctjyigtaia(uxkvkkezbh) = eyplekrugh bxnfckzpuk (gfvzdiguir, hjgodlalrd - sobsfrctzo)
Not Applicable
-
mtffmohvki(mhkpcjnggb) = syavmgvanj zccktanolq (tadrnalfcq, 4.92)
-
09 Apr 2024
Not Applicable
-
-
ifdbaabztg(vawfinxein) = 170; 15.8% nsiypsdhxb (yihiqrcqxo )
-
09 Apr 2024
Phase 3
2,437
(BMI-high)
reyewohcwl(riqgkwamdw) = vxikuiqosw zyplxvnucp (zmrqoolyrh )
Positive
06 Dec 2023
fremanezumab
(BMI-normal)
reyewohcwl(riqgkwamdw) = iwrefewzmf zyplxvnucp (zmrqoolyrh )
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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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