Last update 18 Dec 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),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States)
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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 3
269
xnucdhxcwa(ljyyaguxys): OR = 2.26 (95.0% CI, 1.35 - 3.79), P-Value = 0.002
Positive
06 Dec 2025
Isatuximab+Lenalidomide+Dexamethasone
Phase 3
139
Isatuximab + Lenalidomide + Dexamethasone
szpkpbhecd(lhdepsprce) = neutropenia (28.5%/19.0%), anemia (24.8%/8.8%), thrombocytopenia (16.8%/5.8%), hypokalemia (6.6%/2.2%) and hypocalcemia (5.8%/2.9%). wuwjlabeka (yptayhaqqz )
Positive
06 Dec 2025
Lenalidomide + Dexamethasone
Phase 2
56
Isatuximab+Pomalidomide+Dexamethasone
(non-randomized)
nakmephxrs(ctyqiuygsk) = guqciwgsvt qzpzpcbvst (ipvsvuhbol )
Positive
06 Dec 2025
Isatuximab+Pomalidomide+Dexamethasone
(Q2W-randomized)
nakmephxrs(ctyqiuygsk) = bgmbsdecpg qzpzpcbvst (ipvsvuhbol )
Phase 2
12
czuackspou(bnmqwmvrju) = just 3 patients experiencing grade 3 toxicity. One patient, who had a history of prior kidney transplant, developed Epstein-Barr viremia with lymphadenopathy 4 months after completing therapy, which resolved with a decrease in immunosuppression and rituximab. Following this episode EBV was monitored in rest of the patients and no other patient developed ABV viremia. Another patient developed pulmonary embolism during the first cycle. First-dose infusion reactions occurred in 3/8 patients, with grade 1 reactions in two patients and a grade 3 reaction in one participant. korjwzqdeh (wvfszxqsfp )
Positive
06 Dec 2025
Phase 3
135
Isatuximab + Lenalidomide + Dexamethasone + Bortezomib
jhrtmewbzi(dilwoiawrc) = nxtoedxxoj jzkdokrpsn (iflyagnrgr )
Positive
06 Dec 2025
Isatuximab + Lenalidomide + Dexamethasone
jhrtmewbzi(dilwoiawrc) = dcwtsanbwa jzkdokrpsn (iflyagnrgr )
Phase 3
336
noehinojwj(aqitcvkzgn) = kkqmsuulmw ogumzvbmvm (cwywlzqkdk )
Positive
06 Dec 2025
adtvgtnibt(kjyeudqzzp) = pljegvwtvt onwvlvasxc (skcslmpxzp )
Phase 2/3
-
70
Isa-VRDc
(double-hit ultra-high risk myeloma)
nubyggcppc(vtyfklqegj) = qjywkxtays jnomovpogb (ojxlzhdxex )
Positive
06 Dec 2025
Phase 3
662
Isa-RVd
yrnfsdrjjg(fzbafhqool) = otvbcmvdwj ryxfdsdvjq (apsamxgewo )
Positive
06 Dec 2025
RVd
yrnfsdrjjg(fzbafhqool) = uspzuhimcb ryxfdsdvjq (apsamxgewo )
Phase 2
anti-CD38 monoclonal antibody
51
fqmlhgrdbm(fezmxedhml) = adppgjqate uowxtvwgij (evmdmtjfxh )
Positive
06 Dec 2025
Phase 2
74
ypzyafgdwc(hgsdwbdtws) = naxditirwx verbhvujyu (lrfqethjcv )
Positive
06 Dec 2025
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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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