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Updated: Oct 12, 2025
08:36
Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
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Abrocitinib: First Approval
1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|November 22, 2021
Summary
Abrocitinib, a Janus kinase 1 (JAK1) inhibitor, is now approved in the UK and Japan for moderate-to-severe atopic dermatitis (AD). This oral therapy offers a new treatment option for eligible adults and adolescents.
Area of Science:
- Pharmacology
- Dermatology
- Immunology
Background:
- Atopic dermatitis (AD) is a chronic inflammatory skin condition with significant unmet needs.
- Current systemic therapies for moderate-to-severe AD have limitations.
- Janus kinase (JAK) inhibitors represent a novel therapeutic approach.
Purpose of the Study:
- To summarize the key development milestones of abrocitinib.
- To highlight the regulatory approvals for abrocitinib in atopic dermatitis.
Main Methods:
- Review of preclinical and clinical development data for abrocitinib.
- Analysis of regulatory submission and approval timelines.
- Synthesis of information regarding abrocitinib's mechanism of action.
Main Results:
- Abrocitinib, an oral JAK1 inhibitor, has demonstrated efficacy in treating moderate-to-severe atopic dermatitis.
- Regulatory approvals granted in the UK and Japan in September 2021.
- Positive CHMP opinion received in the EU; submissions in other regions ongoing.
Conclusions:
- Abrocitinib represents a significant advancement in the systemic treatment of moderate-to-severe atopic dermatitis.
- The drug's development pathway highlights successful progression from research to regulatory approval.
- Abrocitinib offers a new targeted therapy option for patients with refractory AD.
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