Skip to main content
SpringerLink
Log in

Delgocitinib: First Approval

  • AdisInsight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Delgocitinib, a janus kinase (JAK) inhibitor, is being developed by Japan Tobacco for the treatment of autoimmune disorders and hypersensitivity, including inflammatory skin conditions. The JAK family of tyrosine kinases plays an important role in mediating the biological effects of several inflammatory cytokines, e.g. IL-4, IL-13 and IL-31, which are elevated in patients with atopic dermatitis. Delgocitinib inhibits all members of the JAK family [JAK1, JAK2, JAK3 and tyrosine kinase 2]. Topical delgocitinib (Corectim®) is approved in Japan for the treatment of atopic dermatitis. This article summarizes the milestones in the development of delgocitinib leading to this first approval for the treatment of adults with atopic dermatitis. Clinical development of the topical formulation is also underway for alopecia areata, chronic hand eczema, discoid lupus erythematosus, inverse psoriasis and atopic dermatitis in several countries worldwide. Clinical development of an oral formulation of delgocitinib is also underway in Japan for the treatment of autoimmune disorders and hypersensitivity.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338–51.

    Article  Google Scholar 

  2. Saeki H, Nakahara T, Tanaka A, et al. Clinical practice guidelines for the management of atopicd dermatitis 2016. J Dermatol. 2016;43(10):1117–45.

    Article  Google Scholar 

  3. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116–32.

    Article  Google Scholar 

  4. Japan Tobacco Inc. CORECTIM® Ointment 0.5% [Japanese Prescribing Information]. 2020. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/530614_26997A2M1020_1_02. Accessed 19 Feb 2020.

  5. LEO Pharma. LEO Pharma and Japan Tobacco enter into license agreement for novel JAK inhibitor drug candidate [media release]. 4 Nov 2014. http://www.leo-pharma.com.

  6. Japan Tobacco. JT and Torii sign exclusive license agreement for development and commercialization of JAK inhibitor in Japan [media release]. 28 Oct 2016. http://www.jt.com.

  7. Japan Tobacco. JT signs exclusive license agreement with ROHTO Pharmaceutical for the development and commercialization of JAK inhibitor in Japan [media release]. 15 Mar 2018. http://www.jt.com.

  8. Tanimoto A, Ogawa Y, Oki C, et al. Pharmacological properties of JTE-052: a novel potent JAK inhibitor that suppresses various inflammatory responses in vitro and in vivo. Inflamm Res. 2015;64(1):41–51.

    Article  CAS  Google Scholar 

  9. Tanimoto A, Shinozaki Y, Yamamoto Y, et al. A novel JAK inhibitor JTE-052 reduces skin inflammation and ameliorates chronic dermatitis in rodent models: comparison with conventional therapeutic agents. Exp Dermatol. 2018;27(1):22–9.

    Article  CAS  Google Scholar 

  10. Amano W, Nakajima S, Kunugi H, et al. The Janus kinase inhibitor JTE-052 improves skin barrier function through suppressing signal transducer and activator of transcription 3 signaling. J Allergy Clin Immunol. 2015;136(3):667–77.

    Article  CAS  Google Scholar 

  11. Amano W, Nakajima S, Yamamoto Y, et al. JAK inhibitor JTE-052 regulates contact hypersensitivity by downmodulating T cell activation and differentiation. J Dermatol Sci. 2016;84(3):258–65.

    Article  CAS  Google Scholar 

  12. Nakagawa H, Nemoto O, Yamada H, et al. Phase 1 studies to assess the safety, tolerability and pharmacokinetics of JTE-052 (a novel Janus kinase inhibitor) ointment in Japanese healthy volunteers and patients with atopic dermatitis. J Dermatol. 2018;45(6):701–9.

    Article  CAS  Google Scholar 

  13. Nakagawa H, Nemoto O, Igarashi A, et al. Delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with moderate to severe atopic dermatitis: a phase 3, randomized, double-blind, vehicle-controlled study and an open-label, long-term extension study. J Am Acad Dermatol. 2020. https://doi.org/10.1016/j.jaad.2019.12.015.

    Article  PubMed  Google Scholar 

  14. Nakagawa H, Nemoto O, Igarashi A, et al. Long-term safety and efficacy of delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with atopic dermatitis. J Dermatol. 2019. https://doi.org/10.1111/1346-8138.15173.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Torii Pharmaceutical. Top-line results of JTE-052 ointment, JAK inhibitor, phase 3 clinical study in pediatric patients with atopic dermatitis (comparative study) in Japan [media release]. 25 Apr 2019. https://www.torii.co.jp/en/.

  16. Nakagawa H, Nemoto O, Igarashi A, et al. Efficacy and safety of topical JTE-052, a Janus kinase inhibitor, in Japanese adult patients with moderate-to-severe atopic dermatitis: a phase II, multicentre, randomized, vehicle-controlled clinical study. Br J Dermatol. 2018;178(2):424–32.

    Article  CAS  Google Scholar 

  17. Nakagawa H, Nemoto O, Igarashi A, et al. Phase 2 clinical study of delgocitinib ointment in pediatric patients with atopic dermatitis. J Allergy Clin Immunol. 2019;144(6):1575–83.

    Article  CAS  Google Scholar 

  18. Worm M, Bauer A, Elsner P, et al. Efficacy and safety of topical delgocitinib in patients with chronic hand eczema: data from a randomized, double-blind, vehicle-controlled phase IIa study. Br J Dermatol. 2019. https://doi.org/10.1111/bjd.18469.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Sohita Dhillon

Authors
  1. Sohita Dhillon
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sohita Dhillon.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. S. Dhillon is a contracted employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.11936214.

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Dhillon, S. Delgocitinib: First Approval. Drugs 80, 609–615 (2020). https://doi.org/10.1007/s40265-020-01291-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-020-01291-2

Search

Navigation