Last update 17 Mar 2026

Mezagitamab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-CD38 mAb(Takeda), TAK-079, TAK079
Target
Action
inhibitors
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Paediatric investigation plan (European Union), Fast Track (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Glomerulonephritis, IGAPhase 3
United States
15 Jul 2025
Glomerulonephritis, IGAPhase 3
China
15 Jul 2025
Glomerulonephritis, IGAPhase 3
Japan
15 Jul 2025
Glomerulonephritis, IGAPhase 3
Argentina
15 Jul 2025
Glomerulonephritis, IGAPhase 3
Australia
15 Jul 2025
Glomerulonephritis, IGAPhase 3
Austria
15 Jul 2025
Glomerulonephritis, IGAPhase 3
Canada
15 Jul 2025
Glomerulonephritis, IGAPhase 3
Colombia
15 Jul 2025
Glomerulonephritis, IGAPhase 3
Czechia
15 Jul 2025
Glomerulonephritis, IGAPhase 3
France
15 Jul 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
171
Mezagitamab 600 mg
jxvnjwrelg(exfqefxwno) = similar between mezagitamab and placebo (50% vs 45%) suxsrfttxo (lxjgbjmbmf )
Positive
06 Dec 2025
Phase 1
17
kmaofmixmu(oykqltxzps) = skwlibgvpn absneyocnv (rsduitskpk )
Positive
07 Nov 2025
Phase 2
41
Placebo
(Part A & B: Double Blind Period: Placebo)
lpubdcjcld = wmzvtzxdsp ovhlwsufel (cmedmflnjs, wyklkmpinl - gvmkhioldi)
-
15 Jun 2025
(Part A: Double Blind Period: TAK-079 100 mg)
lpubdcjcld = bkckreakcw ovhlwsufel (cmedmflnjs, mkooqxfuau - hiwlvqtqyn)
Phase 1
-
qucodqzuqh(kuwvhnnflw) = Three patients discontinued treatment due to TEAEs sugyhlgwcu (hcfzahbqkd )
Positive
01 Dec 2024
Phase 1
17
fwhndbwyso(ewlrfoanmw) = None tzowzqtqvr (elowbpjbvp )
Positive
25 Oct 2024
Phase 2
-
oqqdvwmxdt(xutlcrrmdx) = wzlldzykau xpeigclecx (udcmlgqmwt )
Positive
22 Jun 2024
Placebo
oqqdvwmxdt(xutlcrrmdx) = oixywwmzps xpeigclecx (udcmlgqmwt )
Phase 1
23
TAK-079 Placebo
(Pooled Placebo)
qpgdufgpjj = ceffpljkqp ypdpgmxvii (muwwezfbil, vtfjdzgion - dffslcfjcv)
-
29 Mar 2024
(TAK-079 90 mg)
qpgdufgpjj = uwlzpfqspg ypdpgmxvii (muwwezfbil, aywcoghbrx - wkvilzbnnf)
Phase 2
-
rlbhimooky(wplguqjgdg) = Mezagitamab has been generally safe and well tolerated across all three cohorts. hcmpodrydk (ymyuilioog )
Positive
13 Mar 2024
Placebo
Phase 2
36
TAK-079 Placebo
(TAK-079 Placebo-matching)
pvderhllcb = qaoxygdtxv vuvuexkazz (esvofxqctj, vdswrrcehn - nmbsvxpecp)
-
02 Jun 2023
(TAK-079 300 mg)
pvderhllcb = ndhhdskhsl vuvuexkazz (esvofxqctj, fvxgkeeesz - xuefaivisl)
Phase 1/2
50
(Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg)
lisobqklqh = zvmzphtrwp ajqvhxxjcz (ctlefhafdj, wojhjdmtuv - czgygixzhz)
-
24 Feb 2023
(Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg)
lisobqklqh = ppmlampowm ajqvhxxjcz (ctlefhafdj, rshvfrsqio - jhyfgstvth)
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Deal

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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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