Ulixertinib is an experimental tablet from Biomed Valley Discoveries that blocks ERK, the last switch in a growth signalling chain that drives some cancers. It is being tested in histiocytosis and in gliomas.
Ulixertinib (BVD-523) is Biomed Valley Discoveries' ERK1/2 inhibitor. The company describes it as highly selective, able to cross the blood-brain barrier in adults with low-grade glioma, and active against tumours with NF1, BRAF V600 and non-V600 BRAF mutations, and lists it in phase 2. Trials listed by the company are a phase 2 in histiocytic neoplasms at Memorial Sloan Kettering (NCT06411821), a window-of-opportunity trial in MAPK-activated gliomas at MD Anderson (NCT05804227) and a combination with ruxolitinib in myelofibrosis (NCT06773195). The FDA designated ulixertinib an orphan drug for stage IIb to IV BRAF mutant melanoma on 24 June 2013. On 27 August 2026 the FDA granted Biomed Valley Discoveries a designation for malignant glioma for a product its record describes as a reversible, ATP-competitive ERK1/2 inhibitor, without naming it.
1.Ulixertinib slips into a pocket on MAPK1.
Treatment of Stage IIb through Stage IV BRAF mutant melanoma
FDA orphan drug designation of ulixertinib for BRAF mutant melanoma, granted to BioMed Valley Discoveries source
treatment of malignant glioma
FDA orphan drug designation for malignant glioma, granted to Biomed Valley Discoveries for a reversible, ATP-competitive ERK1/2 inhibitor; the record does not name ulixertinib source
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Query for this drug: (TITLE:"Ulixertinib" OR ABSTRACT:"Ulixertinib" OR TITLE:"BVD-523" OR ABSTRACT:"BVD-523") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Ulixertinib, not a curated reading list.
Shares Glioma & glioblastoma and the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
Shares the tags pipeline, orphan-designation.
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