Momelotinib: First Approval

Declarations Funding The preparation of this review was not supported by any external funding. Authorship and Conflict of interest 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. Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable. Additional information about this Adis Drug Review can be found here. Abstract Momelotinib (OJJAARA) is an oral Janus kinase 1 and 2 (JAK1/JAK2) and activin A receptor, type I (ACVR1) inhibitor that has been developed for the treatment of myelofibrosis (MF). In September 2023, momelotinib was approved in the USA for the treatment of intermediate or high-risk MF, including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. This article summarizes the milestones in the development of momelotinib leading to this first approval for MF. © Springer Nature Switzerland AG 2023