Isatuximab

Summary

Isatuximab (CHEMBL3545131) is an approved antibody (ATC L01FC02) targeting CD38; indicated across 16 conditions including plasma cell myeloma and neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L01FC02
• Targets: 1 (CD38)
• Indications: 16 conditions
• Clinical trials: 88

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3545131
Name	Isatuximab
Type	Antibody
Max phase	4
ATC	L01FC02

Also known as: Isatuximab, Isatuximab irfc, Isatuximab-irfc, SAR-650984, SAR650984, Sarclisa, ISATUXIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
CD38	CD38	Binding	10	0%	P28907

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): CD38.

Top Reactome pathways

4 total, by targets touching each:

Pathway	Targets	Genes
Metabolism	1	CD38
Nicotinate metabolism	1	CD38
Metabolism of water-soluble vitamins and cofactors	1	CD38
Metabolism of vitamins and cofactors	1	CD38

Dominant GO biological processes

GO term	Targets
response to hypoxia	1
signal transduction	1
positive regulation of cytosolic calcium ion concentration	1
female pregnancy	1
response to xenobiotic stimulus	1
negative regulation of neuron projection development	1
artery smooth muscle contraction	1
positive regulation of cell growth	1
positive regulation of B cell proliferation	1
positive regulation of insulin secretion	1
response to estradiol	1
response to retinoic acid	1
response to progesterone	1
response to hydroperoxide	1
B cell proliferation	1

Indications & clinical

Indications

16 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
plasma cell myeloma	4	MONDO:0009693	EFO:0001378
neoplasm	4	MONDO:0005070	EFO:0000616
acute lymphoblastic leukemia	2	MONDO:0004967	EFO:0000220
acute myeloid leukemia	2	MONDO:0018874	EFO:0000222
lymphoma	2	MONDO:0005062	EFO:0000574
smoldering plasma cell myeloma	2	MONDO:0005235	EFO:0003073
T-cell leukemia	2	MONDO:0005525	EFO:0005592
monoclonal gammopathy	2	MONDO:0004960	EFO:0000203
hereditary amyloidosis	2	MONDO:0018634	MONDO:0019438
pure red-cell aplasia	2	MONDO:0001705	MONDO:0001705
lymphoid neoplasm	1	MONDO:0005157	EFO:0001642
immune system disorder	1	MONDO:0005046	EFO:0000540
autoimmune hemolytic anemia	1	MONDO:0020108	EFO:1001264
diffuse large B-cell lymphoma	1	MONDO:0018905	EFO:0000403
colorectal neoplasm	1	MONDO:0005335	MONDO:0005575

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 88.

Phase distribution

Phase	Trials
PHASE2	42
PHASE1/PHASE2	15
PHASE1	13
PHASE3	12
PHASE2/PHASE3	2
EARLY_PHASE1	2
PHASE4	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07334535	PHASE4	NOT_YET_RECRUITING	Isa-VRD in TIE HRMM
NCT03319667	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
NCT03617731	PHASE3	ACTIVE_NOT_RECRUITING	Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)
NCT04270409	PHASE3	ACTIVE_NOT_RECRUITING	Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
NCT04751877	PHASE3	ACTIVE_NOT_RECRUITING	Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years).
NCT04934475	PHASE3	ACTIVE_NOT_RECRUITING	MInimal Residual Disease Adapted Strategy
NCT05558319	PHASE3	NOT_YET_RECRUITING	NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide
NCT05665140	PHASE2/PHASE3	RECRUITING	Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients
NCT06182774	PHASE3	RECRUITING	Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
NCT06216158	PHASE3	RECRUITING	Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
NCT06860269	PHASE2/PHASE3	RECRUITING	A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia
NCT02990338	PHASE3	COMPLETED	Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
NCT03275285	PHASE3	COMPLETED	Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
NCT05675319	PHASE3	TERMINATED	Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy
NCT05804032	PHASE3	COMPLETED	Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma
NCT02960555	PHASE2	ACTIVE_NOT_RECRUITING	Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)
NCT03104842	PHASE2	ACTIVE_NOT_RECRUITING	Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone
NCT03989414	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
NCT04126200	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
NCT04240054	PHASE2	RECRUITING	Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency
NCT04430894	PHASE2	ACTIVE_NOT_RECRUITING	KRDI in Transplant-Eligible MM
NCT04558931	PHASE2	RECRUITING	Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma
NCT04614558	PHASE2	RECRUITING	Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
NCT04643002	PHASE1/PHASE2	RECRUITING	Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
NCT04653246	PHASE2	ACTIVE_NOT_RECRUITING	Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM
NCT04786028	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in ND-TEMM
NCT04850599	PHASE2	ACTIVE_NOT_RECRUITING	Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma
NCT04883242	PHASE2	ACTIVE_NOT_RECRUITING	Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
NCT04891809	PHASE2	ACTIVE_NOT_RECRUITING	Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM
NCT05123131	PHASE2	ACTIVE_NOT_RECRUITING	Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma
NCT05145400	PHASE2	RECRUITING	Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
NCT05272826	PHASE2	RECRUITING	Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients
NCT05344833	PHASE2	RECRUITING	Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
NCT05346809	PHASE2	RECRUITING	Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
NCT05559827	PHASE2	NOT_YET_RECRUITING	Efficacy of the antiCD38 Monoclonal Antibody Isatuximab in the Treatment of PCRA by Major ABO Mismatch After Allogeneic Hematopoietic Stem Cell Transplantation
NCT05669989	PHASE2	ACTIVE_NOT_RECRUITING	International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
NCT05690984	PHASE2	ACTIVE_NOT_RECRUITING	Elimination of Minimal Residual Disease After Transplant
NCT05704049	PHASE2	ACTIVE_NOT_RECRUITING	A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT05776979	PHASE2	RECRUITING	Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients
NCT05873205	PHASE2	ACTIVE_NOT_RECRUITING	Open-Label, Phase II Trial of Isatuximab for Patients With Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

3 molecules share ≥1 primary target. Top 3 by shared-target count:

Molecule	Source	Status	Shared targets
QUERCETIN	ChEMBL + PubChem	Phase 3 (approved)	CD38
LUTEOLIN	ChEMBL	Phase 2	CD38
Resveratrol	PubChem	Approved	CD38