{"entity":{"id":"ulixertinib","kind":"drug","name":"Ulixertinib","aka":["BVD-523"],"tldr":"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.","summary":"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.","status":"phase-2","asOf":"2026-11-04","links":[{"label":"Biomed Valley Discoveries: ulixertinib","url":"https://biomed-valley.com/ulixertinib/"},{"label":"ClinicalTrials.gov: NCT05804227 (gliomas)","url":"https://clinicaltrials.gov/study/NCT05804227"},{"label":"ClinicalTrials.gov: NCT06411821 (histiocytic neoplasms)","url":"https://clinicaltrials.gov/study/NCT06411821"}],"tags":["pipeline","orphan-designation"],"related":[],"cancers":["braf-v600-melanoma","glioblastoma"],"sections":[],"technologies":[],"targets":["mapk1","mapk3"],"drugs":[],"companies":["biomed-valley-discoveries"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo startup monitors","editedOn":"2026-11-04"},"code":"BVD-523","modality":"Oral small-molecule kinase inhibitor","mechanism":"Inhibits ERK1 and ERK2, the final kinases of the MAPK (RAS, RAF, MEK, ERK) signalling pathway, so that tumours driven by BRAF, NF1 or other MAPK alterations upstream lose the signal, as the developer describes it.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2013-06-24","type":"designation","region":"US","note":"FDA orphan drug designation of ulixertinib for BRAF mutant melanoma, granted to BioMed Valley Discoveries","source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=398213","indication":"Treatment of Stage IIb through Stage IV BRAF mutant melanoma"},{"date":"2026-08-27","type":"designation","region":"US","note":"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":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1173826","indication":"treatment of malignant glioma"}]},"route":"/drugs/ulixertinib/","neighbours":{"cancer":[{"id":"braf-v600-melanoma","kind":"cancer","name":"BRAF V600-mutant melanoma","route":"/cancers/braf-v600-melanoma/"},{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"}],"target":[{"id":"mapk1","kind":"target","name":"MAPK1","route":"/targets/mapk1/"},{"id":"mapk3","kind":"target","name":"MAPK3","route":"/targets/mapk3/"}],"company":[{"id":"biomed-valley-discoveries","kind":"company","name":"Biomed Valley Discoveries","route":"/companies/biomed-valley-discoveries/"}]}}