Ozoralizumab: First Approval
- PMID: 36509938
- DOI: 10.1007/s40265-022-01821-0
Ozoralizumab: First Approval
Abstract
Ozoralizumab (Nanozora®), a trivalent anti-tumour necrosis factor alpha (TNFα) NANOBODYⓇ compound, has been developed by Taisho Pharmaceutical Co. Ltd (under license from Ablynx, an affiliate of Sanofi) for the treatment of rheumatoid arthritis (RA). In September 2022, ozoralizumab was approved in Japan for the treatment of RA that is inadequately managed by current available treatments. This article summarizes the milestones in the development of ozoralizumab leading to this first approval.
© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Similar articles
-
[Pharmacological profiles and clinical efficacy of ozoralizumab (Nanozora® 30 mg Syringes for S.C. Injection), the first Nanobody® compound in Japan].Nihon Yakurigaku Zasshi. 2023;158(6):490-499. doi: 10.1254/fpj.23051. Nihon Yakurigaku Zasshi. 2023. PMID: 37914330 Japanese.
-
Ozoralizumab: first Nanobody® therapeutic for rheumatoid arthritis.Expert Opin Biol Ther. 2023 Jul-Dec;23(7):579-587. doi: 10.1080/14712598.2023.2231344. Epub 2023 Jul 11. Expert Opin Biol Ther. 2023. PMID: 37431762 Review.
-
Ozoralizumab, a Humanized Anti-TNFα NANOBODY® Compound, Exhibits Efficacy Not Only at the Onset of Arthritis in a Human TNF Transgenic Mouse but Also During Secondary Failure of Administration of an Anti-TNFα IgG.Front Immunol. 2022 Feb 22;13:853008. doi: 10.3389/fimmu.2022.853008. eCollection 2022. Front Immunol. 2022. PMID: 35273620 Free PMC article.
-
Unique structure of ozoralizumab, a trivalent anti-TNFα NANOBODY® compound, offers the potential advantage of mitigating the risk of immune complex-induced inflammation.Front Immunol. 2023 Apr 14;14:1149874. doi: 10.3389/fimmu.2023.1149874. eCollection 2023. Front Immunol. 2023. PMID: 37122706 Free PMC article.
-
Structural, nonclinical, and clinical features of ozoralizumab: A novel tumour necrosis factor inhibitor.Mod Rheumatol. 2023 Nov 1;33(6):1059-1067. doi: 10.1093/mr/road038. Mod Rheumatol. 2023. PMID: 37185766 Review.
Cited by
-
Bispecific Antibodies in Solid Tumors: Advances and Challenges.Int J Mol Sci. 2025 Jun 18;26(12):5838. doi: 10.3390/ijms26125838. Int J Mol Sci. 2025. PMID: 40565299 Free PMC article. Review.
-
Evaluation of the Potential Impact of In Silico Humanization on VHH Dynamics.Int J Mol Sci. 2023 Sep 26;24(19):14586. doi: 10.3390/ijms241914586. Int J Mol Sci. 2023. PMID: 37834033 Free PMC article.
-
Fast In Vitro Synthesis and Direct Labeling of Nanobodies for Prototyping in Microscopy Applications.ACS Omega. 2024 Aug 9;9(33):35374-35383. doi: 10.1021/acsomega.4c01164. eCollection 2024 Aug 20. ACS Omega. 2024. PMID: 39184460 Free PMC article.
-
A pivotal decade for bispecific antibodies?MAbs. 2024 Jan-Dec;16(1):2321635. doi: 10.1080/19420862.2024.2321635. Epub 2024 Mar 11. MAbs. 2024. PMID: 38465614 Free PMC article.
-
Co-delivery of indomethacin and uricase as a new strategy for inflammatory diseases associated with high uric acid.Drug Deliv Transl Res. 2024 Jul;14(7):1820-1838. doi: 10.1007/s13346-023-01487-5. Epub 2023 Dec 21. Drug Deliv Transl Res. 2024. PMID: 38127247
References
-
- McInnes IB, Buckley CD, Isaacs JD. Cytokines in rheumatoid arthritis: shaping the immunological landscape. Nat Rev Rheumatol. 2016;12(1):63–8. - DOI
-
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2021;73(7):1108–23. - DOI
-
- Kawahito Y, Morinobu A, Kaneko Y, et al. Drug treatment algorithm and recommendations from the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis: secondary publication. Mod Rheumatol. 2022. https://doi.org/10.1093/mr/roac017 . - DOI
-
- Smolen JS, Landewe RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685–99. - DOI
-
- Taisho Pharmaceutical Company Ltd. Ozoralizumab (Nanozora®): Japanese prescribing information. 2022. http://medical.taisho.co.jp/di/brand/nz/product.php?bdname=nz&brand=nz . Accessed 20 Oct 2022
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical