Ivarmacitinib Sulfate: First Approval

<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Authorship and Conflict of interest</b> 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. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> not applicable</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="https://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank">here.</a></p><p dir="ltr"><b>Abstract</b></p><p dir="ltr">Ivarmacitinib sulfate (ivarmacitinib; 艾速达^®), a selective Janus kinase 1 (JAK1) inhibitor, is being developed by Jiangsu Hengrui Pharmaceuticals Co, Ltd Co, Ltd for the treatment of immune-mediated inflammatory diseases. In March 2025, ivarmacitinib was approved for use in adult patients with active ankylosing spondylitis (AS) who have responded poorly to or are intolerant to ≥ 1 tumour necrosis factor (TNF) inhibitors in China. In March 2025, ivarmacitinib was also approved in China for use in adult patients with moderate to severe active rheumatoid arthritis (RA) who have responded poorly to or are intolerant to ≥ 1 TNF inhibitors. In April 2025, ivarmacitinib was approved in China for use in adult patients with moderate to severe atopic dermatitis (AD) who have had an inadequate response or intolerance to topical or other systemic treatments. This article summarizes the milestones in the development of ivarmacitinib leading to this first approval for the treatment of adult patients with active AS.</p><p dir="ltr">© Springer Nature Switzerland AG 2025</p>