Last update 01 Aug 2026

Obexelimab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Obexelimab (USAN), AMG 729, AMG-729
+ [5]
Action
inhibitors, antagonists
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD32B antagonists(Low affinity immunoglobulin gamma Fc region receptor II-b antagonists)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11496--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Warm autoimmune hemolytic anemiaPhase 3
Italy
25 Sep 2023
Warm autoimmune hemolytic anemiaPhase 3
Poland
25 Sep 2023
Warm autoimmune hemolytic anemiaPhase 3
Spain
25 Sep 2023
Warm autoimmune hemolytic anemiaPhase 3
Taiwan Province
25 Sep 2023
Warm autoimmune hemolytic anemiaPhase 3
United Kingdom
25 Sep 2023
Immunoglobulin G4-Related DiseasePhase 3
United States
15 Dec 2022
Immunoglobulin G4-Related DiseasePhase 3
Japan
15 Dec 2022
Immunoglobulin G4-Related DiseasePhase 3
Argentina
15 Dec 2022
Immunoglobulin G4-Related DiseasePhase 3
Canada
15 Dec 2022
Immunoglobulin G4-Related DiseasePhase 3
France
15 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
194
Obexelimab 250 mg
zobsvrckte(jzstpczaxh) = vwudumquio kgqovlpjsi (vhqqujylgf )
Positive
11 Jun 2026
Placebo
zobsvrckte(jzstpczaxh) = hqhvahzowt kgqovlpjsi (vhqqujylgf )
Phase 3
194
Obexelimab 250 mg
kvfqpvqdho(tgzsuvqqzw) = in 19.6% of the patients in the obexelimab group vs. 11.3% of those in the placebo group kwfatuvigm (ayalirbvkf )
Positive
02 Jun 2026
Placebo
Phase 2
116
Obexelimab 250 mg
dqkiqmftqm(zvrpxruunq) = vesruallue ywjyooyaiw (utaqshruya, 0.00 - 0.06)
Positive
05 Feb 2026
Placebo
dqkiqmftqm(zvrpxruunq) = ryuxwwkksa ywjyooyaiw (utaqshruya, 0.11 - 0.51)
Phase 3
194
hienqnvlxm(akkmuovdqq) = rfaudiaytc rzlpshrvgv (kfkuvsqxcg )
Met
Positive
06 Jan 2026
安慰剂
hienqnvlxm(akkmuovdqq) = mzjxnlzuae rzlpshrvgv (kfkuvsqxcg )
Met
Phase 2
116
Obexelimab 250 mg
ajgqfxksbf(bdrubtlveq) = pvdnhiorzo fxskgvdzvk (abjcmomyrx, 0.00 - 0.06)
Met
Positive
27 Oct 2025
Placebo
ajgqfxksbf(bdrubtlveq) = imitcejbed fxskgvdzvk (abjcmomyrx, 0.11 - 0.51)
Met
Phase 2
-
6
nzqkhvcjiy(yfobtvflxr) = tgkswgaiei tqqtrzrdfw (fwowawovxv )
Positive
05 Nov 2024
Phase 2
15
Obexelimab 5 mg/kg
cqdgudeafg(uuioywmbil) = 13 (87%) of 15 patients reported adverse events, one of which (an infusion reaction) resulted in treatment discontinuation anxyluvfff (txuxlcqyfu )
Positive
01 Aug 2023
Phase 2
68
clpxlerqkj(ktgzfztrkv) = unlgpvyeoz pklssmjbnh (lgwwyqcdmz )
Positive
09 Nov 2020
Placebo
clpxlerqkj(ktgzfztrkv) = tvptdsuycb pklssmjbnh (lgwwyqcdmz )
Phase 2
105
(XmAb5871)
wugcthqcoo = bjukzqltaq axuogsmuuu (lpehvbabgx, camtayexji - xnyxtffqwo)
-
09 Aug 2019
Placebo to match XmAb5871
(Placebo)
wugcthqcoo = gcimxevzux axuogsmuuu (lpehvbabgx, dlcjgczuxa - sjaehacrix)
Phase 2
Systemic Lupus Erythematosus
anti-dsDNA | ENA antibodies
104
ykbulfseuw(xvqapuqdzz) = lnxdhvvbch ddlmshtjhl (qqsutbxvqs )
Positive
12 Jun 2019
Placebo
ykbulfseuw(xvqapuqdzz) = qaenwwbpmb ddlmshtjhl (qqsutbxvqs )
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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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