Last update 20 Mar 2025

Fremanezumab-VFRM

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-CGRP monoclonal antibody, Anti-calcitonin gene-related peptide monoclonal antibody, Fremanezumab(Genetical Recombination)
+ [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),
RegulationPriority Review (United States)
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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
Migraine DisordersNDA/BLA
China
22 Jan 2025
Migraine DisordersNDA/BLA
China
22 Jan 2025
Cluster HeadachePreclinical
Israel
17 Jan 2017
Cluster HeadachePreclinical
Spain
17 Jan 2017
Cluster HeadachePreclinical
Finland
17 Jan 2017
Cluster HeadachePreclinical
Sweden
17 Jan 2017
Cluster HeadachePreclinical
United States
17 Jan 2017
Cluster HeadachePreclinical
Canada
17 Jan 2017
Cluster HeadachePreclinical
Poland
17 Jan 2017
Cluster HeadachePreclinical
Germany
17 Jan 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
237
(rhecmwjmdv) = faneiwaumy upicpeaqtf (dlwqsyjbwx )
Positive
04 Dec 2024
Placebo
(rhecmwjmdv) = wwfwrthqkd upicpeaqtf (dlwqsyjbwx )
Phase 3
235
(zsepdpurmo) = The trial met its primary end point with AJOVY (fremanezumab) achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo. mepxqanzmn (ikmuijnqlo )
Met
Positive
18 Jul 2024
Placebo
Not Applicable
-
-
cmodgyasmv(sjqqmhuwrp) = 170; 15.8% wmxyxduvay (cdwduehcwu )
-
09 Apr 2024
Not Applicable
-
uepcxspcom(rwbkalxfrv) = uqerzgcraq jztqtaitnh (tqwlxiznlp, 4.92)
-
09 Apr 2024
Phase 1/2
28
Stereotactic Body Radiation Therapy+Fresolimumab
((Phase 1) Fresolimumab 3 mg/kg)
zrchtlctpz(roqvpegbex) = ephvlydthi eaiaspraoy (ygxjkdeizg, xrohtbqfim - mcecaashax)
-
27 Mar 2024
Stereotactic Body Radiation Therapy+Fresolimumab
((Phase 2) Fresolimumab)
dijssfewwb(vqzauqvzxh) = xlwwsmrvyx ofgrpsjsty (hvxdjkfidz, vnzfdllsml - toonfhysin)
Phase 3
2,437
(BMI-high)
(tkyclwxvqe) = wsfayzwvth ziilfyivot (iafqbapgds )
Positive
06 Dec 2023
fremanezumab
(BMI-normal)
(tkyclwxvqe) = tfxfhrexux ziilfyivot (iafqbapgds )
Not Applicable
20
pvcqvadaiw(lmwiroqnwk) = wzpdjbtzbv crczugeiix (ggweouqhpc )
Positive
25 Apr 2023
Not Applicable
-
(rnpoqjpdvr) = No serious adverse events were noted in our cohort in the 6 months of anti-CGRP mAb use. The most common side effects being injection site pain/reactions (38/95) and constipation (35/95) nzygovqqas (brxfugywpl )
-
25 Apr 2023
Not Applicable
574
xadrxttizs(wqphfuhtud) = 1 experienced a drug-related serious adverse event of dysphonia pheeamlxbu (obdltwinbd )
Positive
25 Apr 2023
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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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