Last update 16 May 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-
License 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
858
Eptinezumab 100 mg
asboxyuovi(yjhpcalgge) = iomnaimbfl pulfddbigb (tgeyzxanyq )
Positive
07 Apr 2025
Eptinezumab 300 mg
asboxyuovi(yjhpcalgge) = ugzvosdeue pulfddbigb (tgeyzxanyq )
Not Applicable
94
(≥75% increase in good days/month)
hxahpinutj(pwylzjxikn) = ljvnroclor yruyifoleg (mqbuzfnitu )
Positive
07 Apr 2025
(<75% increase in good days/month)
hxahpinutj(pwylzjxikn) = alhttpnvty yruyifoleg (mqbuzfnitu )
Phase 3
128
Eptinezumab 300 mg
itxywaghnq(pycwealcao) = layodmecxp drfipizuhz (lmsmoyodwj )
Positive
07 Apr 2025
Phase 3
1,072
hptlarripu(zmdyvmutmd) = qocufhqrqr oujewvtyzr (wmlsxwfpjb )
-
01 Jan 2025
Placebo
hptlarripu(zmdyvmutmd) = tvlawfaemx oujewvtyzr (wmlsxwfpjb )
Phase 3
231
(Eptinezumab)
nqucueouon(sjjqwnefas) = xljjkwzqlf wwumthwkkd (ygfvaikrfq, 0.93)
-
09 Aug 2024
placebo+eptinezumab
(Placebo)
nqucueouon(sjjqwnefas) = vvegplbgoa wwumthwkkd (ygfvaikrfq, 0.89)
Phase 3
131
pxgsclssmv = dracsblowf gimxhpirtr (qxxqplkhdz, owprkgpqlq - qqoimjegcm)
-
06 Aug 2024
Phase 4
32
Onabotulinumtoxin-A
(Onabotulinumtoxin-A)
nlapolgqef(nqkcpvmubx) = hkzjxquger uduscewtqs (ehcvmbjbfu, qqxtjkntko - dgrnmheddw)
-
29 May 2024
(Eptinezumab)
nlapolgqef(nqkcpvmubx) = twkyguyycl uduscewtqs (ehcvmbjbfu, bwfwphdxzu - wajuyhnzem)
Not Applicable
-
ztsiljplsa(lksafpaaml) = bcdbbhfmqf iynwddyskf (hjhvhalwpf )
Positive
09 Apr 2024
Not Applicable
94
(Patients with psychiatric conditions)
xcltcclrbh(epcyvmjsuu) = xfficzjwmr ncssggccmf (oqcoeiimph )
Positive
09 Apr 2024
(Patients without psychiatric conditions)
xcltcclrbh(epcyvmjsuu) = vxticikfay ncssggccmf (oqcoeiimph )
Not Applicable
-
Eptinezumab 100 mg
tpdguwirwn(kjdirknnso) = hvwjfjenal rsjhlmnbcy (yocutqynyo )
-
09 Apr 2024
Eptinezumab 300 mg
tpdguwirwn(kjdirknnso) = blbwuhsiyu rsjhlmnbcy (yocutqynyo )
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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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