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Nuvisertib, also known by its development codes TP-3654 and SGI-9481, is a small-molecule chemical substance being developed by Sumitomo Pharma America, with Tolero Pharmaceuticals as the originator.[2] It is classified as an antineoplastic, antifibrotic, and anti-inflammatory agent.[2] Nuvisertib is not an authorised medicine; it is an investigational substance currently being studied in clinical trials.[3] The European Medicines Agency granted nuvisertib orphan designation for the treatment of myelofibrosis on 18 July 2025, which provides regulatory support to the developer but does not mean the medicine is available or authorised for use.[3]
Nuvisertib is described as an inhibitor of PIM kinases, specifically PIM1, PIM2, and PIM3 proteins, as well as a phosphatidylinositol 3 kinase inhibitor.[2] PIM kinases are proteins that play a role in cell survival, growth, and proliferation. By blocking these proteins, nuvisertib aims to interfere with the abnormal cell signalling that contributes to myelofibrosis, a condition in which scar tissue builds up in the bone marrow and disrupts normal blood cell production.[2]
Nuvisertib is given orally, meaning it is taken by mouth.[1] In the registered trial, it is being studied both as a monotherapy (given alone) and in combination with momelotinib, another oral medicine.[1]
One clinical trial is registered for nuvisertib: NCT04176198, a Phase 1/2 study in patients with intermediate or high-risk primary or secondary myelofibrosis.[1] The trial is currently authorised and plans to enrol up to 245 participants.[1] The Phase 1 part aims to identify the recommended Phase 2 dose of nuvisertib, both alone and in combination with momelotinib, and to determine overall safety.[1] The Phase 2 part aims to assess preliminary clinical activity, measured as a spleen volume response of at least 35% reduction (SVR35) at any time.[1] Adverse events are also being characterised by type, frequency, severity, seriousness, and relationship to the study drugs.[1]
No detailed side effect information for nuvisertib is available from the provided sources. The clinical trial is measuring adverse events as a primary outcome in Phase 1, which means safety data are being collected but have not been reported in the registry record.[1]
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