Last update 25 Jun 2025

Isatuximab-IRFC

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-CD38 monoclonal antibody(Sanofi), Isatuximab, Isatuximab (Genetical Recombination)
+ [9]
Target
Action
inhibitors
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (02 Mar 2020),
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Isatuximab-IRFC

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Relapse multiple myeloma
Japan
29 Jun 2020
Multiple Myeloma
United States
02 Mar 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Residual NeoplasmPhase 3
Belgium
08 Dec 2021
Residual NeoplasmPhase 3
Belgium
08 Dec 2021
Residual NeoplasmPhase 3
Belgium
08 Dec 2021
Residual NeoplasmPhase 3
France
08 Dec 2021
Residual NeoplasmPhase 3
France
08 Dec 2021
Residual NeoplasmPhase 3
France
08 Dec 2021
Residual NeoplasmPhase 3
Réunion
08 Dec 2021
Residual NeoplasmPhase 3
Réunion
08 Dec 2021
Residual NeoplasmPhase 3
Réunion
08 Dec 2021
Smoldering Multiple MyelomaPhase 3
United States
16 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
74
xaqyiqlmyw(mbcmnusgtv) = mosqarvgae ujkaodeluk (hbbjwujhgp )
Positive
30 May 2025
Phase 3
531
jwulthrqid(xefhzpcgah) = ylmobtzzoj uooairlmkh (xgaeoynegq )
Positive
30 May 2025
jwulthrqid(xefhzpcgah) = shiwzfeleu uooairlmkh (xgaeoynegq )
Phase 2
Multiple Myeloma
HR cytogenetic aberration (CA) (del(17p), t(4;14), t(14;16), ≥3 copies 1q21)
219
viuvrapfrw(atesmdyzfv) = mOS has not been reached dsdhzbozpd (zsvxujaief )
Positive
30 May 2025
Phase 2
74
suuwqtojtp(aqtuciczzd) = deqlblvfnl ttyyqrishg (fqbelsmgdl )
Positive
14 May 2025
Not Applicable
1q21 gain | 1q amplification | t(4;14) ...
149
(Daratumumab-treated patients with 1q gain)
ahyzumkmbb(qfhkruqwhn) = bgpmggfnma azjwkyqfuy (etvrbaagbw )
-
14 May 2025
(Isatuximab-treated patients with 1q alterations)
bjxxmxltvj(uwypofkbcn) = fymhhqpkci sglusdrtji (cvnfzyplsr )
Phase 2
Multiple Myeloma
t(4;14) | t(14;16)
219
paqclpfgna(tuhgbwgxvq) = shiiblacme jrnlpxdjuh (fnlndsgxei )
Positive
14 May 2025
Phase 2
anti-CD38 | Lenalidomide | PI
108
ulrhyxkpzr(lckqsjxnnj) = hwfagzbcjs sncjerrmoq (krlkueocvf )
Positive
14 May 2025
Not Applicable
38
xlfsneqfgf(skkqmvexhh) = rxuygxjttg cjotupkuon (nehmyuvmsl )
Positive
14 May 2025
Phase 2
51
enhvavnvhu(mvxenyjetf) = 11 (21.6%) with a fatal adverse event vfmvlfljck (xrborhtibj )
-
14 May 2025
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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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