Last update 19 Sep 2026

Anselamimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Fibril-reactive monoclonal antibody 11-1F4, 11-1F4, CAEL 101
+ [4]
Target
Action
inhibitors
Mechanism
APP inhibitors(Beta amyloid A4 protein inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Immunoglobulin Light-Chain Amyloidosis
Japan
16 Sep 2026
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Plasma cell dyscrasiaPhase 3
United States
25 Aug 2020
Plasma cell dyscrasiaPhase 3
China
25 Aug 2020
Plasma cell dyscrasiaPhase 3
Japan
25 Aug 2020
Plasma cell dyscrasiaPhase 3
Australia
25 Aug 2020
Plasma cell dyscrasiaPhase 3
Austria
25 Aug 2020
Plasma cell dyscrasiaPhase 3
Belgium
25 Aug 2020
Plasma cell dyscrasiaPhase 3
Brazil
25 Aug 2020
Plasma cell dyscrasiaPhase 3
Canada
25 Aug 2020
Plasma cell dyscrasiaPhase 3
Czechia
25 Aug 2020
Plasma cell dyscrasiaPhase 3
France
25 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
125
Placebo+CAEL-101
(Combined CAEL-101 + Plasma Cell Dyscrasia Treatment and Placebo + Plasma Cell Dyscrasia Treatment)
pmjewifsrd = crysuflxjq jueovkuquf (qnlhhfvpoz, fqgyjahrkt - uxxymzrxej)
-
02 Jul 2026
(CAEL-101 + Plasma Cell Dyscrasia Treatment)
sglfifyiys = acbbsvcvek xtmreyttep (pllkcrarkc, sknoefgnzd - mycinklpbr)
Phase 3
281
Placebo+CAEL-101
(Combined CAEL-101 + Plasma Cell Dyscrasia Treatment and Placebo + Plasma Cell Dyscrasia Treatment)
fumfjfixjl = heaxzbyzoq emskjntpai (bwkqdlgcfq, orpvqwtdxy - otoizjmsby)
-
17 Jun 2026
(CAEL-101 + Plasma Cell Dyscrasia Treatment)
nhlxnqrgxo = schgizzzlo kzdczeoapn (fefgkgasxi, bhhnszeyaa - rjxfbpmkiu)
Phase 3
-
tkmeeoxriu(ojdkhrrfxx) = did not achieve statistical significance for the primary endpoint compared to placebo. Anselamimab showed highly clinically meaningful improvement in time to ACM and frequency of CVH in a prespecified subgroup of patients, compared to placebo. llihtpvjkn (gblbqsgnex )
Not Met
Negative
16 Jul 2025
Placebo
Phase 3
Immunoglobulin Light-Chain Amyloidosis
First line
N-terminal pro b-type natriuretic peptide (NT-proBNP) | involved/uninvolved free light chain difference (dFLC)
-
Anselamimab + CyBorD ± daratumumab
aeeludivol(cpsapvjayz) = agbjrfdgub jrkopjjhhs (ipqyoplfgt, 2476 - 5758)
Positive
14 May 2024
Placebo + CyBorD ± daratumumab
aeeludivol(cpsapvjayz) = qbyewkotdm jrkopjjhhs (ipqyoplfgt, 10254 - 22884)
Phase 1
22
xibmwnumro(vmtvymvhnj) = No delayed adverse events occurred cmgyvvbbdj (fzrsssowiv )
Positive
31 May 2023
Phase 2
25
dvgmlkmgdc(dxvabwxqkp) = bdqkcwztqr oyijfsjitu (noxhglsezr )
Positive
05 Nov 2021
Phase 2
13
CAEL-101+CyBorD
grgrtfkwnk(tzqdhgpsyk) = trvszbskil rybqwiwsha (vmlikskcbd )
-
09 Jun 2021
Phase 2
13
kfyarunfwr(mydiluayjh) = none iogakssnzn (pypiukuzod )
Positive
05 Nov 2020
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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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