Abrocitinib

Short Description:

API’s Name Indication Innovator Patent Expiry Date(The U.S)
Abrocitinib Atopic Dermatitis Pfizer Feb.11, 2034


Product Detail

Product Tags

PRODUCT DETAIL

Abrocitinib is an oral, small molecule, Janus kinase (JAK) 1 inhibitor in development for the treatment of adults and adolescents with moderate to severe atopic dermatitis.

Abrocitinib is under investigation in clinical trial NCT03796676 (JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis).

Abrocitinib is currently being developed by Pfizer for the treatment of atopic dermatitis (eczema). It is an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor.

Atopic dermatitis (AD) is a complex, chronic, inflammatory skin disease characterized by pruritic, intense itching, and eczematous lesions affecting about 25% of children and 2% to 3% of adults worldwide. Abrocitinib is a selective inhibitor of Janus kinase-1 (JAK1) enzyme inhibiting the inflammatory process. Therefore, we aimed to assess the efficacy and safety of abrocitinib for moderate-to-severe AD.

Abrocitinib in dose 100 mg or 200 mg is an effective, well-tolerated, and promising drug in treating patients with moderate-to-severe atopic dermatitis. However, the analysis favored the efficacy of abrocitinib 200 mg over 100 mg, but side effects such as nausea and headache are likely to occur more with 200 mg.

CERTIFICATE

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

QUALITY MANAGEMENT

Quality management1

Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect. 

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.

PRODUCTION MANAGEMENT

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Korea Countec Bottled Packaging Line

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Taiwan CVC Bottled Packaging Line

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Italy CAM Board Packaging Line

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German Fette Compacting Machine

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Japan Viswill Tablet Detector

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DCS Control Room

PARTNER

International cooperation
International cooperation
Domestic cooperation
Domestic cooperation

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