Literature DB >> 32166597

Delgocitinib: First Approval.

Sohita Dhillon1.   

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.

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Year:  2020        PMID: 32166597     DOI: 10.1007/s40265-020-01291-2

Source DB:  PubMed          Journal:  Drugs        ISSN: 0012-6667            Impact factor:   9.546


  13 in total

1.  A novel JAK inhibitor JTE-052 reduces skin inflammation and ameliorates chronic dermatitis in rodent models: Comparison with conventional therapeutic agents.

Authors:  Atsuo Tanimoto; Yuichi Shinozaki; Yasuo Yamamoto; Yoshiaki Katsuda; Eriko Taniai-Riya; Kaoru Toyoda; Kochi Kakimoto; Yukari Kimoto; Wataru Amano; Noriko Konishi; Mikio Hayashi
Journal:  Exp Dermatol       Date:  2017-07-03       Impact factor: 3.960

2.  Efficacy and safety of topical delgocitinib in patients with chronic hand eczema: data from a randomized, double-blind, vehicle-controlled phase IIa study.

Authors:  M Worm; A Bauer; P Elsner; V Mahler; S Molin; T S S Nielsen
Journal:  Br J Dermatol       Date:  2019-11-08       Impact factor: 9.302

3.  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.

Authors:  Hidemi Nakagawa; Osamu Nemoto; Atsuyuki Igarashi; Hidehisa Saeki; Hironobu Kaino; Takeshi Nagata
Journal:  J Am Acad Dermatol       Date:  2020-02-03       Impact factor: 11.527

4.  The Janus kinase inhibitor JTE-052 improves skin barrier function through suppressing signal transducer and activator of transcription 3 signaling.

Authors:  Wataru Amano; Saeko Nakajima; Hayato Kunugi; Yasuharu Numata; Akihiko Kitoh; Gyohei Egawa; Teruki Dainichi; Tetsuya Honda; Atsushi Otsuka; Yukari Kimoto; Yasuo Yamamoto; Atsuo Tanimoto; Mutsuyoshi Matsushita; Yoshiki Miyachi; Kenji Kabashima
Journal:  J Allergy Clin Immunol       Date:  2015-06-24       Impact factor: 10.793

5.  JAK inhibitor JTE-052 regulates contact hypersensitivity by downmodulating T cell activation and differentiation.

Authors:  Wataru Amano; Saeko Nakajima; Yasuo Yamamoto; Atsuo Tanimoto; Mutsuyoshi Matsushita; Yoshiki Miyachi; Kenji Kabashima
Journal:  J Dermatol Sci       Date:  2016-09-13       Impact factor: 4.563

Review 6.  Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis.

Authors:  Lawrence F Eichenfield; Wynnis L Tom; Sarah L Chamlin; Steven R Feldman; Jon M Hanifin; Eric L Simpson; Timothy G Berger; James N Bergman; David E Cohen; Kevin D Cooper; Kelly M Cordoro; Dawn M Davis; Alfons Krol; David J Margolis; Amy S Paller; Kathryn Schwarzenberger; Robert A Silverman; Hywel C Williams; Craig A Elmets; Julie Block; Christopher G Harrod; Wendy Smith Begolka; Robert Sidbury
Journal:  J Am Acad Dermatol       Date:  2013-11-27       Impact factor: 11.527

7.  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.

Authors:  H Nakagawa; O Nemoto; A Igarashi; T Nagata
Journal:  Br J Dermatol       Date:  2018-01-15       Impact factor: 9.302

8.  Clinical Practice Guidelines for the Management of Atopic Dermatitis 2016.

Authors:  Hidehisa Saeki; Takeshi Nakahara; Akio Tanaka; Kenji Kabashima; Makoto Sugaya; Hiroyuki Murota; Tamotsu Ebihara; Yoko Kataoka; Michiko Aihara; Takafumi Etoh; Norito Katoh
Journal:  J Dermatol       Date:  2016-10       Impact factor: 4.005

9.  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.

Authors:  Hidemi Nakagawa; Osamu Nemoto; Hiroyuki Yamada; Takeshi Nagata; Noriko Ninomiya
Journal:  J Dermatol       Date:  2018-04-17       Impact factor: 4.005

10.  Long-term safety and efficacy of delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with atopic dermatitis.

Authors:  Hidemi Nakagawa; Osamu Nemoto; Atsuyuki Igarashi; Hidehisa Saeki; Ryusei Murata; Hironobu Kaino; Takeshi Nagata
Journal:  J Dermatol       Date:  2019-12-09       Impact factor: 4.005

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  17 in total

Review 1.  New Topical Therapies in Development for Atopic Dermatitis.

Authors:  Egídio Freitas; Melinda Gooderham; Tiago Torres
Journal:  Drugs       Date:  2022-05-21       Impact factor: 9.546

2.  A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata.

Authors:  Daniela Mikhaylov; Jacob W Glickman; Ester Del Duca; John Nia; Peter Hashim; Giselle K Singer; Alba L Posligua; Aleksandra G Florek; Erin Ibler; Erika L Hagstrom; Yeriel Estrada; Stephanie M Rangel; Maria Colavincenzo; Amy S Paller; Emma Guttman-Yassky
Journal:  Arch Dermatol Res       Date:  2022-03-01       Impact factor: 3.017

Review 3.  The JAK/STAT signaling pathway: from bench to clinic.

Authors:  Xiaoyi Hu; Jing Li; Maorong Fu; Xia Zhao; Wei Wang
Journal:  Signal Transduct Target Ther       Date:  2021-11-26

Review 4.  JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.

Authors:  Yiming Luo; Madison Alexander; Massimo Gadina; John J O'Shea; Francoise Meylan; Daniella M Schwartz
Journal:  J Allergy Clin Immunol       Date:  2021-10       Impact factor: 14.290

Review 5.  Emerging Role of Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis.

Authors:  Rhea Singh; Courtney E Heron; Rima I Ghamrawi; Lindsay C Strowd; Steven R Feldman
Journal:  Immunotargets Ther       Date:  2020-11-10

Review 6.  Atopic dermatitis: an expanding therapeutic pipeline for a complex disease.

Authors:  Thomas Bieber
Journal:  Nat Rev Drug Discov       Date:  2021-08-20       Impact factor: 84.694

7.  Degradation of Janus Kinase for Potential Application in Immune Response Therapeutics.

Authors:  Robert B Kargbo
Journal:  ACS Med Chem Lett       Date:  2021-02-09       Impact factor: 4.345

8.  Strain-Release Driven Spirocyclization of Azabicyclo[1.1.0]butyl Ketones.

Authors:  Jasper L Tyler; Adam Noble; Varinder K Aggarwal
Journal:  Angew Chem Int Ed Engl       Date:  2021-04-16       Impact factor: 15.336

9.  Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis.

Authors:  Monika D Scuron; Brittany L Fay; Andrew J Connell; Michael T Peel; Paul A Smith
Journal:  Front Immunol       Date:  2021-02-15       Impact factor: 7.561

Review 10.  The infectious complications of atopic dermatitis.

Authors:  Vivian Wang; Juri Boguniewicz; Mark Boguniewicz; Peck Y Ong
Journal:  Ann Allergy Asthma Immunol       Date:  2020-08-07       Impact factor: 6.347

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