[CAS NO. 1584645-37-3] Rozanolixizumab

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PRODUCTS SPECIFICATIONS [1584645-37-3]

Catalog

HY-P9979

Brand

MCE

CAS

1584645-37-3

DESCRIPTION [1584645-37-3]

Overview

MDL	-
Molecular Weight	-
Molecular Formula	-
SMILES	[Rozanolixizumab]

For research use only. We do not sell to patients.

Summary

Rozanolixizumab (UCB7665), a humanized high-affinity anti-human neonatal Fc receptor (FcRn) monoclonal antibody (IgG4P), is used to the research of reducing pathogenic IgG in autoimmune and alloimmune diseases ^[1] .

In Vitro

Rozanolixizumab binds to human FcRn and cynomolgus monkey FcRn with a similar affinity at both pH 6.0 (K _d 23 pM and 25 pM, human and cynomolgus monkey, respectively) and pH 7.4 (34 pM and 53 pM, human and cynomolgus monkey, respectively. Rozanolixizumab is observed to inhibit the recycling (IC ₅₀ 0.41 nM) of human IgG by human FcRn-transfected MDCK cells in a dose-dependent manner. Recycling of IgG was also inhibits in cynomolgus monkey FcRn-transfected MDCK cells (IC ₅₀ 0.98nM) ^[1] .
Rozanolixizumab causes an increase in intracellular IgG AF647 ^[1] .

MedChemExpress (MCE) has not independently confirmed the accuracy of these methods. They are for reference only.

In Vivo

Intravenous (IV) rozanolixizumab dosing in cynomolgus monkeys demonstrated non-linear pharmacokinetics indicative of target-mediated drug disposition; single IV rozanolixizumab doses (30 mg/kg) in cynomolgus monkeys reduced plasma IgG concentration by 69% by Day 7 post-administration. Daily IV administration of rozanolixizumab (initial 30 mg/kg loading dose; 5 mg/kg daily thereafter) reduced plasma IgG concentrations in all cynomolgus monkeys, with low concentrations maintained throughout the treatment period (42 days) ^[1] .

MedChemExpress (MCE) has not independently confirmed the accuracy of these methods. They are for reference only.

Clinical Trial

NCT Number	Sponsor	Condition	Start Date	Phase
NCT04224688	UCB Biopharma SRL\|UCB Pharma	Primary Immune Thrombocytopenia	June 3, 2020	Phase 3
NCT05643794	UCB Biopharma SRL\|UCB Pharma	Fibromyalgia	December 21, 2022	Phase 2
NCT05014724	UCB Biopharma SRL\|UCB Pharma	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT04875975	UCB Biopharma SRL\|UCB Pharma	Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis	September 27, 2021	Phase 2
NCT02718716	UCB Biopharma S.P.R.L.\|Parexel\|UCB Pharma	Thrombocytopenia	March 2016	Phase 2
NCT04200456	UCB Biopharma SRL\|UCB Pharma	Primary Immune Thrombocytopenia	January 31, 2020	Phase 3
NCT03971422	UCB Biopharma SRL\|UCB Pharma	Generalized Myasthenia Gravis	June 3, 2019	Phase 3
NCT03861481	UCB Biopharma S.P.R.L.\|UCB Pharma	Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)	March 26, 2019	Phase 2
NCT04124965	UCB Biopharma SRL\|UCB Pharma	Generalized Myasthenia Gravis	October 29, 2019	Phase 3
NCT03052751	UCB Biopharma S.P.R.L.\|UCB Pharma	Myasthenia Gravis	May 15, 2017	Phase 2
NCT04828343	UCB Biopharma SRL\|UCB Pharma	Healthy Study Participants	April 22, 2021	Phase 1
NCT05063162	UCB Biopharma SRL\|UCB Pharma	Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)	February 2, 2022	Phase 3
NCT05681715	UCB Biopharma SRL\|UCB Pharma	Generalized Myasthenia Gravis	April 17, 2023	Phase 3
NCT02220153	UCB Celltech\|Parexel\|UCB Pharma	Healthy	July 2014	Phase 1
NCT04596995	UCB Biopharma SRL\|UCB Pharma	Primary Immune Thrombocytopenia	December 30, 2020	Phase 3
NCT04051944	UCB Biopharma SRL\|UCB Pharma	Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)	August 21, 2019	Phase 2
NCT03859219	UCB Biopharma S.P.R.L.\|UCB Pharma	Healthy-volunteers	March 18, 2019	Phase 1
NCT04650854	UCB Biopharma SRL\|UCB Pharma	Generalized Myasthenia Gravis	February 3, 2021	Phase 3

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References

[1] Smith B, et al. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018;10(7):1111-1130.