Is tofacitinib (Shangjie) available in a cream formulation and a version for external use on skin?

Tofacitinib is mainly an oral JAK inhibitor. The currently approved dosage form is an oral tablet, which is used for the treatment of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and other autoimmune diseases. There is currently no officially widely approved cream / topical dosage form on the market. Most national drug regulatory agencies (such as the U.S. FDA) have approved the tablet form for systemic immunomodulatory treatment, but the topical cream or gel form has not yet been officially approved for sale as a regular commercial drug.

Although the topical formulation of tofacitinib has not been approved by mainstream regulatory authorities, there are indeed explorations of topological (topical) formulations of tofacitinib in scientific research and clinical studies, such as tofacitinib cream/gel is being studied in clinical trials for psoriasis, mild to moderate skin diseases, and specific cutaneous lymphomas. These studies used tofacitinib-containing small molecule cream designed to locally inhibit inflammatory signaling pathways and reduce systemic side effects. Specific examples include research on a cream for mild to moderate chronic plaque psoriasis, which shows that topical tofacitinib can alleviate lesions to a certain extent, but it is still in the experimental stage and has not been converted into an officially marketed drug.

In some countries (such as India), companies have launched tofacitinib topical ointment. / Cream products are used for eczema and other conditions. For example, tofacitinib 2% ointment is reported to be approved for the treatment of atopic dermatitis. Such products can be used legally after registration with local drug regulatory authorities, but their indications, instructions for use and regulatory requirements are completely different from oral preparations, and they are still regionally approved products in specific countries, rather than globally recognized standard dosage forms.

It should be noted that even if there are topical preparations on the market in individual countries, there is no standard officially approved cream/topical version in mainstream markets such as the United States, the European Union, and China. Therefore, the clinical use of tofacitinib cream for skin problems such as skin inflammation, vitiligo, and alopecia is usually in the form of research use, prescription preparation, or individualized formulation (compounding). It needs to be conducted under the guidance of a doctor and in compliance with local regulations and safety assessments.

Keyword tags:

Tofacitinib,JAKinhibitor, topical dosage form, cream, dermatological application, clinical study, non-standard dosage form

Reference materials:https://www.cancer.gov/publications/dictionaries/cancer-drug