# Ulixertinib

Source: https://onco.cc/drugs/ulixertinib/  
OnCo record `ulixertinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-11-04
- Also known as: BVD-523
- Tags: pipeline; orphan-designation
- 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.

## Sources

- Biomed Valley Discoveries: ulixertinib: https://biomed-valley.com/ulixertinib/
- ClinicalTrials.gov: NCT05804227 (gliomas): https://clinicaltrials.gov/study/NCT05804227
- ClinicalTrials.gov: NCT06411821 (histiocytic neoplasms): https://clinicaltrials.gov/study/NCT06411821

## Connected records

- cancers: [BRAF V600-mutant melanoma](https://onco.cc/cancers/braf-v600-melanoma/), [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/)
- targets: [MAPK1](https://onco.cc/targets/mapk1/), [MAPK3](https://onco.cc/targets/mapk3/)
- companies: [Biomed Valley Discoveries](https://onco.cc/companies/biomed-valley-discoveries/)

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