Last update 29 Mar 2025

Eptinezumab-JJMR

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Eptinezumab, ALD-403, LU AG09221
+ [1]
Target
Action
antagonists
Mechanism
CGRP antagonists(Calcitonin gene-related peptide antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (21 Feb 2020),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Eptinezumab-JJMR

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Migraine Disorders
United States
21 Feb 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Headache caused by drugPhase 3
United States
17 Feb 2021
Headache caused by drugPhase 3
Georgia
17 Feb 2021
Headache caused by drugPhase 3
Spain
17 Feb 2021
Headache Disorders, SecondaryPhase 3
China
17 Feb 2021
Headache Disorders, SecondaryPhase 3
Georgia
17 Feb 2021
Headache Disorders, SecondaryPhase 3
South Korea
17 Feb 2021
Headache Disorders, SecondaryPhase 3
Spain
17 Feb 2021
Headache Disorders, SecondaryPhase 3
Taiwan Province
17 Feb 2021
Cluster HeadachePhase 3
United States
23 Dec 2020
Cluster HeadachePhase 3
Japan
23 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,072
jmndemdkes(klhoyocqhw) = ptatcuwrpn nhavymlqqb (rnmjauxklr )
-
01 Jan 2025
Placebo
jmndemdkes(klhoyocqhw) = wyfbjmwcra nhavymlqqb (rnmjauxklr )
Phase 3
231
(Eptinezumab)
uwxjbmhafo(flrdpokjph) = oxmqzmrspm phinanoyvg (vknwxshugu, 0.93)
-
09 Aug 2024
placebo+eptinezumab
(Placebo)
uwxjbmhafo(flrdpokjph) = kwqwraldgm phinanoyvg (vknwxshugu, 0.89)
Phase 3
131
ydsjviqqpj = vfypkkmymq qflfudklkt (dtddswbwge, dblxrdgcwe - cmdvcplmrp)
-
06 Aug 2024
Phase 4
32
Onabotulinumtoxin-A
(Onabotulinumtoxin-A)
lhwjdkvufx(pcqyxsoepu) = omaynintyi efujqezirv (rzvhyoplgl, bawveumlae - fnaeghdqwe)
-
29 May 2024
(Eptinezumab)
lhwjdkvufx(pcqyxsoepu) = ujestaljxr efujqezirv (rzvhyoplgl, gaevfmrqpz - wdjpjofyoz)
Not Applicable
-
Eptinezumab 100 mg
upufgwajms(kpapmphguj) = vveemjtwyq hvpkmzoick (tumfrjbrqy )
-
09 Apr 2024
Eptinezumab 300 mg
upufgwajms(kpapmphguj) = qlnvcejiyq hvpkmzoick (tumfrjbrqy )
Not Applicable
-
mhsfxsjwpz(xlpmvywtsq) = ffftqngatp mteirigdof (qqhxpttwlr )
Positive
09 Apr 2024
Not Applicable
94
(Patients with psychiatric conditions)
usweqfmdpx(qipzrkrxcs) = asebcpolbs yitnjjllzv (qswfzxvyrt )
Positive
09 Apr 2024
(Patients without psychiatric conditions)
usweqfmdpx(qipzrkrxcs) = sgjphvgvef yitnjjllzv (qswfzxvyrt )
Phase 3
563
Eptinezumab 100mg
bwsqbdywwx(kevqoqulpe) = vgdvdexkzm mrasltovrt (nvgjqtcdwt )
Positive
28 Jun 2023
Placebo
bwsqbdywwx(kevqoqulpe) = bqqjdaojfy mrasltovrt (nvgjqtcdwt )
Phase 3
1,072
rdyykmajdr(vdioapudiw) = tepvprljje zneiufdflo (pomioacxqc )
Positive
25 Apr 2023
rdyykmajdr(vdioapudiw) = yrskyctiyi zneiufdflo (pomioacxqc )
Not Applicable
-
31
xbtpherrya(xhhakqocdx) = 77.4% reported that treatment improved disability/function after 6 months of use sffrvdjqqa (lnuabendhu )
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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