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Updated: Aug 17, 2025

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Ozoralizumab: First Approval.

Susan J Keam1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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|December 12, 2022
PubMed
Summary

Ozoralizumab (Nanozora®) is a new rheumatoid arthritis treatment targeting tumour necrosis factor alpha. It received Japanese approval in September 2022 for patients with inadequate response to existing therapies.

Area of Science:

  • Immunology
  • Pharmacology
  • Biotechnology

Background:

  • Rheumatoid arthritis (RA) is a chronic autoimmune disease causing joint inflammation and damage.
  • Tumour necrosis factor alpha (TNFα) is a key pro-inflammatory cytokine implicated in RA pathogenesis.
  • Existing biologic therapies targeting TNFα have shown efficacy but can have limitations.

Purpose of the Study:

  • To summarize the development milestones of ozoralizumab (Nanozora®) leading to its first regulatory approval.
  • To highlight the significance of ozoralizumab as a novel therapeutic option for rheumatoid arthritis.

Main Methods:

  • Development of ozoralizumab, a trivalent anti-TNFα NANOBODY® compound.
  • Regulatory review process and approval in Japan.

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Main Results:

  • Ozoralizumab (Nanozora®) was approved in Japan in September 2022.
  • The approval is for the treatment of RA inadequately managed by current therapies.

Conclusions:

  • Ozoralizumab represents a significant advancement in RA treatment.
  • The development pathway highlights successful biopharmaceutical innovation.