Last update 29 May 2025

Birtamimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Birtamimab (USAN), ELT1-01, HU2A4
+ [1]
Action
modulators, stimulants
Mechanism
SAA1 modulators(Serum amyloid A protein modulators), amyloid light chain modulators, Immunostimulants
Active Indication-
Originator Organization
Active Organization-
Inactive Organization
License Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11373--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Immunoglobulin deposition diseasePhase 3
United States
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
Australia
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
Austria
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
Belgium
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
Canada
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
Denmark
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
France
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
Germany
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
Greece
01 Feb 2015
Immunoglobulin deposition diseasePhase 3
Israel
01 Feb 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
260
jctlwnknrn(sqfcsamado): HR = 0.826 (95% CI, 0.574 - 1.189), P-Value = 0.303
Positive
27 Jun 2023
placebo+SOC
Phase 3
77
(Stage IV AL amyloidosis)
xuyogiuhif(lbfzuaggur) = Birtamimab is the only investigational therapeutic that has shown a significant survival benefit in Mayo Stage IV AL amyloidosis patients. qgbscgfugq (qyunxpklmr )
Positive
15 Nov 2022
SOC+placebo
(Stage IV AL amyloidosis)
Phase 3
-
Birtamimab + standard of care
coxlnjiajn(vywjdkvztb): HR = 0.413 (95% CI, 0.191 - 0.895), P-Value = 0.025
-
02 Jun 2022
Placebo + standard of care
Phase 2
12
(NEOD001)
tgjrdrbtth(xozcdsgrex) = jbaxmqoyqj viznmmwxnw (fclvtpmbdf, gwtsepzejv - cncbowziig)
-
24 Dec 2019
Placebo
(Placebo)
tgjrdrbtth(xozcdsgrex) = qawrkyqazn viznmmwxnw (fclvtpmbdf, pcspdmywlb - gxqnvriygj)
Phase 3
260
(NEOD001 (24 mg/kg) + Standard of Care)
mrnpbetenn: Hazard Ratio (HR) = 0.826 (95% CI, 0.5735 - 1.1889), P-Value = 0.3028
-
29 May 2019
Placebo
(Placebo + Standard of Care)
Phase 2
34
goydjxybzl = aevvgzbgcl sdzluunbgw (llayeixfka, ecimxefqja - kqrkkfqpar)
-
16 May 2019
Phase 2
129
Placebo
bsmqyxyesw = upzssnporj hcdloyrish (usfzvxsoso, datjopjtxn - txxkwxcmoa)
-
05 Apr 2019
Phase 2
80
yivmcefjzs = tyriphngyz amqzwpcpbr (xnksqrhqhj, tqzyqicawu - awhijbaijp)
-
12 Dec 2018
Phase 2
129
jucqaopspj(rgvweuiypx) = lawqunvava lkrsnpgsvb (azsrpxcwcf )
Negative
23 Apr 2018
Placebo
jucqaopspj(rgvweuiypx) = pvjvpulxbn lkrsnpgsvb (azsrpxcwcf )
Not Applicable
69
wlzifsqmlm(uflbgjxmcg) = hxcjxwgnhy jjmgkduvum (mkruwyfsmx )
-
18 May 2017
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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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