Rozanolixizumab

Summary

Rozanolixizumab (CHEMBL4297820) is an approved antibody (ATC L04AG16) targeting FCGRT; indicated across 5 conditions including myasthenia gravis and autoimmune thrombocytopenic purpura.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L04AG16
• Targets: 1 (FCGRT)
• Indications: 5 conditions
• Clinical trials: 24

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297820
Name	Rozanolixizumab
Type	Antibody
Max phase	4
ATC	L04AG16

Also known as: Rozanolixizumab, Rozanolixizumab-noli, Rystiggo, UCB-7665, Ucb7665, UCB7665, ROZANOLIXIZUMAB

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
FCGRT	Fc fragment of IgG receptor and transporter	Binding	8.7	0%	P55899

Bioactivity

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

Target pathways

Aggregated over 1 target gene(s): FCGRT.

Dominant GO biological processes

GO term	Targets
IgG immunoglobulin transcytosis in epithelial cells mediated by FcRn immunoglobulin receptor	1
immune response	1

Indications & clinical

Indications

5 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
myasthenia gravis	4	MONDO:0009688	EFO:0004991
autoimmune thrombocytopenic purpura	3	MONDO:0008558	EFO:0007160
chronic inflammatory demyelinating polyradiculoneuropathy	2	MONDO:0006702	EFO:1000868
thrombocytopenia	2	MONDO:0002049	HP:0001873
fibromyalgia	2	MONDO:0005546	EFO:0005687

Clinical trials

Total trials: 24.

Phase distribution

Phase	Trials
PHASE3	11
PHASE2	6
PHASE1	4
PHASE4	1
PHASE2/PHASE3	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07246564	PHASE4	RECRUITING	Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis
NCT05063162	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)
NCT06149559	PHASE2/PHASE3	RECRUITING	A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
NCT06540144	PHASE3	ENROLLING_BY_INVITATION	An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
NCT07463521	PHASE3	NOT_YET_RECRUITING	A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
NCT07465289	PHASE3	NOT_YET_RECRUITING	A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
NCT03971422	PHASE3	COMPLETED	A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
NCT04124965	PHASE3	COMPLETED	A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
NCT04200456	PHASE3	TERMINATED	A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
NCT04224688	PHASE3	TERMINATED	A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
NCT04596995	PHASE3	TERMINATED	A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
NCT04650854	PHASE3	COMPLETED	A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
NCT05681715	PHASE3	COMPLETED	A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
NCT02718716	PHASE2	COMPLETED	Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
NCT03052751	PHASE2	COMPLETED	Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
NCT03861481	PHASE2	COMPLETED	A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT04051944	PHASE2	COMPLETED	A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT04875975	PHASE2	TERMINATED	A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
NCT05643794	PHASE2	COMPLETED	A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
NCT02220153	PHASE1	COMPLETED	A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers
NCT03859219	PHASE1	COMPLETED	A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese, Chinese and Caucasian Study Participants
NCT04828343	PHASE1	COMPLETED	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
NCT06720714	PHASE1	COMPLETED	A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
NCT05014724	Not specified	NO_LONGER_AVAILABLE	CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)

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).