Inebilizumab

Summary

Inebilizumab (CHEMBL2109334) is an approved antibody (ATC L04AG10) targeting CD19; indicated across 13 conditions including neuromyelitis optica and myasthenia gravis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L04AG10
• Targets: 1 (CD19)
• Indications: 13 conditions
• Clinical trials: 29

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2109334
Name	Inebilizumab
Type	Antibody
Max phase	4
ATC	L04AG10

Also known as: Inebilizumab, Inebilizumab cdon, Inebilizumab-cdon, MEDI-551, MEDI551, Uplizna, INEBILIZUMAB

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
CD19	CD19	Binding	10.3	2.5%	P15391

Bioactivity

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

Target pathways

Aggregated over 1 target gene(s): CD19.

Top Reactome pathways

17 total, by targets touching each:

Pathway	Targets	Genes
PIP3 activates AKT signaling	1	CD19
Adaptive Immune System	1	CD19
Signal Transduction	1	CD19
Disease	1	CD19
Complement cascade	1	CD19
Innate Immune System	1	CD19
Immune System	1	CD19
Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell	1	CD19
Negative regulation of the PI3K/AKT network	1	CD19
PI3K/AKT Signaling in Cancer	1	CD19
Constitutive Signaling by Aberrant PI3K in Cancer	1	CD19
Diseases of signal transduction by growth factor receptors and second messengers	1	CD19
PI5P, PP2A and IER3 Regulate PI3K/AKT Signaling	1	CD19
Intracellular signaling by second messengers	1	CD19
Regulation of Complement cascade	1	CD19
Antigen activates B Cell Receptor (BCR) leading to generation of second messengers	1	CD19
Signaling by the B Cell Receptor (BCR)	1	CD19

Dominant GO biological processes

GO term	Targets
B-1 B cell differentiation	1
B cell proliferation involved in immune response	1
immunoglobulin mediated immune response	1
B cell proliferation	1
antigen receptor-mediated signaling pathway	1
B cell receptor signaling pathway	1
regulation of B cell receptor signaling pathway	1
regulation of B cell activation	1
positive regulation of release of sequestered calcium ion into cytosol	1
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transduction	1
adaptive immune response	1
immune system process	1
B cell mediated immunity	1

Indications & clinical

Indications

13 indications (1 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
neuromyelitis optica	4	MONDO:0019100	EFO:0004256
myasthenia gravis	3	MONDO:0009688	EFO:0004991
systemic sclerosis	3	MONDO:0005100	EFO:0000717
B-cell chronic lymphocytic leukemia	2	MONDO:0004948	EFO:0000095
diffuse large B-cell lymphoma	2	MONDO:0018905	EFO:0000403
plasma cell myeloma	2	MONDO:0009693	EFO:0001378
autoimmune disorder of the nervous system	2	MONDO:0002977	MONDO:0020640
lymphoid neoplasm	1	MONDO:0005157	EFO:0001642
lymphoma	1	MONDO:0005062	EFO:0000574
scleroderma	1	MONDO:0019340	EFO:1001993
multiple sclerosis	1	MONDO:0005301	MONDO:0005301
neoplasm	1	MONDO:0005070	MONDO:0004992

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

Clinical trials

Total trials: 29.

Phase distribution

Phase	Trials
PHASE2	9
PHASE3	5
Not specified	5
PHASE4	3
PHASE1	3
PHASE1/PHASE2	2
PHASE2/PHASE3	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06180278	PHASE4	ACTIVE_NOT_RECRUITING	Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
NCT07010302	PHASE4	NOT_YET_RECRUITING	Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD
NCT06212245	PHASE4	UNKNOWN	A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
NCT04524273	PHASE3	ACTIVE_NOT_RECRUITING	Myasthenia Gravis Inebilizumab Trial
NCT04540497	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
NCT05198557	PHASE3	ACTIVE_NOT_RECRUITING	A Study of MT-0551 in Patients With Systemic Sclerosis
NCT07132398	PHASE3	NOT_YET_RECRUITING	Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD
NCT07598825	PHASE3	NOT_YET_RECRUITING	A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
NCT02200770	PHASE2/PHASE3	COMPLETED	N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
NCT04372615	PHASE2	RECRUITING	The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis
NCT05549258	PHASE2	RECRUITING	Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
NCT06570798	PHASE2	RECRUITING	A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
NCT06987539	PHASE2	RECRUITING	A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
NCT07222553	PHASE2	NOT_YET_RECRUITING	Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
NCT00983619	PHASE1/PHASE2	COMPLETED	A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies
NCT01453205	PHASE2	COMPLETED	A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
NCT01466153	PHASE2	COMPLETED	A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
NCT02271945	PHASE1/PHASE2	COMPLETED	Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas
NCT03218163	PHASE2	TERMINATED	MEDI-551 as Maintenance Therapy After Allogeneic Stem Cell Transplant in Multiple Myeloma
NCT04174677	PHASE2	WITHDRAWN	Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
NCT00946699	PHASE1	COMPLETED	A Study of the Safety and Tolerability of MEDI-551 in Scleroderma
NCT01585766	PHASE1	COMPLETED	Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
NCT01957579	PHASE1	COMPLETED	A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
NCT01861340	EARLY_PHASE1	COMPLETED	Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma
NCT05891379	Not specified	RECRUITING	Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
NCT05909761	Not specified	RECRUITING	Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
NCT06590051	Not specified	AVAILABLE	AMG 335 Expanded Access Program for IgG4-Related Disease
NCT07159893	Not specified	NOT_YET_RECRUITING	Inectolizumab With Steroid Optimization in Newly Treated NMOSD
NCT06068829	Not specified	UNKNOWN	Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

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

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).