Rozanolixizumab

Rozanolixizumab
Monoclonal antibody
Type	Whole antibody
Source	Chimeric/humanized hybrid
Target	Neonatal Fc receptor (FCGRT)
Clinical data
Trade names	Rystiggo
Other names	UCB-7665, rozanolixizumab-noli
AHFS/Drugs.com	Monograph
MedlinePlus	a623040
License data	US DailyMed: Rozanolixizumab;
Routes of; administration	Subcutaneous
ATC code	L04AG16 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); CA: ℞-only; US: ℞-only; EU: Rx-only;
Identifiers
CAS Number	1584645-37-3;
DrugBank	DB14919;
UNII	P7186074QC;
KEGG	D12182;
Chemical and physical data
Formula	C6462H9984N1704O2016S44
Molar mass	145211.51 g·mol−1

Rozanolixizumab, sold under the brand name Rystiggo, is a monoclonal antibody used for the treatment of myasthenia gravis.^[3] Rozanolixizumab is a humanized and chimeric monoclonal antibody;^[6] and is a neonatal Fc receptor blocker.^[3]^[6]

The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.^[7]

Rozanolixizumab was approved for medical use in the United States in June 2023,^[8]^[9]^[10] and in the European Union in January 2024.^[4]

Medical uses

Rozanolixizumab is indicated for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.^[3]^[11]

Society and culture

Names

Rozanolixizumab is the international nonproprietary name.^[6]

Legal status

In November 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rystiggo, intended for the treatment of myasthenia gravis.^[12] The applicant for this medicinal product is UCB Pharma.^[12] Rozanolixizumab was approved for medical use in the European Union in January 2024.^[4]^[5]

References

^ https://www.tga.gov.au/resources/prescription-medicines-registrations/rystiggo-ucb-australia-pty-ltd-ta-ucb-pharma-division-ucb-australia
^ "Summary Basis of Decision for Rystiggo". Drug and Health Products Portal. 19 June 2025. Retrieved 10 July 2025.
^ ^a ^b ^c ^d "Rystiggo- rozanolixizumab injection, solution". DailyMed. U.S. National Library of Medicine. 30 June 2023. Archived from the original on 29 August 2023. Retrieved 29 August 2023.
^ ^a ^b ^c "Rystiggo EPAR". European Medicines Agency. 22 April 2020. Retrieved 18 March 2024.
^ ^a ^b "Rystiggo Product information". Union Register of medicinal products. 8 January 2024. Retrieved 18 March 2024.
^ ^a ^b ^c World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
^ "FDA Roundup: June 27, 2023". U.S. Food and Drug Administration (FDA). 27 June 2023. Archived from the original on 27 June 2023. Retrieved 28 June 2023. This article incorporates text from this source, which is in the public domain.
^ "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 28 June 2023. Archived from the original on 21 January 2023. Retrieved 28 June 2023.
^ "UCB announces U.S. FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis" (Press release). UCB. 27 June 2023. Archived from the original on 28 June 2023. Retrieved 28 June 2023 – via PR Newswire.
^ Hoy SM (November 2023). "Correction to: Rozanolixizumab: First Approval". Drugs. 83 (16): 1569. doi:10.1007/s40265-023-01960-y. PMC 10624700. PMID 37861882.
^ "Drug Approval Package: Rystiggo". U.S. Food and Drug Administration (FDA). 25 July 2023. Archived from the original on 20 November 2023. Retrieved 20 November 2023.
^ ^a ^b "Rystiggo: Pending EC decision". European Medicines Agency (EMA). 10 November 2023. Archived from the original on 13 November 2023. Retrieved 5 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

External links

Clinical trial number NCT03971422 for "A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis" at ClinicalTrials.gov

[1] ttps://www.tga.gov.au/resources/prescription-medicines-registrations/rystiggo-ucb-australia-pty-ltd-ta-ucb-pharma-division-ucb-australia

[2] "Summary Basis of Decision for Rystiggo". Drug and Health Products Portal. 19 June 2025. Retrieved 10 July 2025.

[Rystiggo_FDA_label-3] "Rystiggo- rozanolixizumab injection, solution". DailyMed. U.S. National Library of Medicine. 30 June 2023. Archived from the original on 29 August 2023. Retrieved 29 August 2023.

[Rystiggo_EPAR-4] "Rystiggo EPAR". European Medicines Agency. 22 April 2020. Retrieved 18 March 2024.

[Rystiggo_PI-5] "Rystiggo Product information". Union Register of medicinal products. 8 January 2024. Retrieved 18 March 2024.

[WHORecList77-6] World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.

[FDA_PR_20230627-7] "FDA Roundup: June 27, 2023". U.S. Food and Drug Administration (FDA). 27 June 2023. Archived from the original on 27 June 2023. Retrieved 28 June 2023. This article incorporates text from this source, which is in the public domain.

[8] "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 28 June 2023. Archived from the original on 21 January 2023. Retrieved 28 June 2023.

[9] "UCB announces U.S. FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis" (Press release). UCB. 27 June 2023. Archived from the original on 28 June 2023. Retrieved 28 June 2023 – via PR Newswire.

[Hoy_2023-10] Hoy SM (November 2023). "Correction to: Rozanolixizumab: First Approval". Drugs. 83 (16): 1569. doi:10.1007/s40265-023-01960-y. PMC 10624700. PMID 37861882.

[11] "Drug Approval Package: Rystiggo". U.S. Food and Drug Administration (FDA). 25 July 2023. Archived from the original on 20 November 2023. Retrieved 20 November 2023.

[Rystiggo:_Pending_EC_decision-12] "Rystiggo: Pending EC decision". European Medicines Agency (EMA). 10 November 2023. Archived from the original on 13 November 2023. Retrieved 5 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[1]

[2]

[3]

[4]

[5]

[6]

[7]

[8]

[9]

[10]

[11]

[12]