Ulixertinib

Phase 2Small molecule

NNational Cancer Institute (NCI)

Ulixertinib is one of 90 small molecule programs targeting Myelofibrosis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

MyelofibrosisRecruiting

Advanced LymphomaActive, not recruiting

Advanced Malignant Solid NeoplasmActive, not recruiting

Histiocytic NeoplasmsRecruiting

Tumor, SolidRecruiting

GliomasRecruiting

MyelofibrosisPhase 2

Recruiting

Advanced LymphomaPhase 2

Active, not recruiting

Advanced Malignant Solid NeoplasmPhase 2

Active, not recruiting

Histiocytic NeoplasmsPhase 2

Recruiting

Tumor, SolidPhase 1

Recruiting

GliomasPhase 1

Recruiting

Competition

Competitive Landscape

47 competitors in Myelofibrosis

#DrugCompanyPhaseTrials

Jakafi

Incyte

Approved

55 2

Ojjaara

GGlaxo Dba Glaxosmithkline

Approved

7 3

Rifadin

Tepadina

Droxia

1 6

Sporanox

SSebela Pharmaceuticals Development LLC

Vonjo

5 8

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

3 9

Navitoclax

AbbVie

Phase 3

5 10

Rytelo

GGeron Corporation

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Advanced Lymphoma

NCT06400225

Q1 2027

Phase 2Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT03155620

Phase 2Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT03698994

Q2 2027

Phase 2Recruiting

Histiocytic Neoplasms

NCT06411821

Q3 2027

Phase 1Recruiting

Gliomas

NCT05804227

Clinical

Trials by Indication[1]

Advanced Lymphoma2 trials

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

MATCH Treatment Subprotocol Z1L: BVD-523FB (Ulixertinib) in Patients With Tumors With BRAF Fusions, or With Non-V600E, Non-V600K BRAF Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06400225·35 enrolled

Advanced Malignant Solid Neoplasm2 trials

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of BVD-523FB (Ulixertinib) in Patients With Tumors Harboring Activating MAPK Pathway Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03698994·20 enrolled

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,377 enrolled

Malignancies1 trial

Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies

Available·XxCures··NCT04566393

Advanced Malignancies1 trial

Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

Terminated·BBioMed Valley Discoveries, Inc·Phase 2·NCT04488003·104 enrolled

Adenocarcinoma1 trial

Ulixertinib (BVD-523) and Hydroxychloroquine in Patients W Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas

Completed·UUniversity of Utah·Phase 1·NCT04145297·16 enrolled

6 more indications

Gastrointestinal1 trial

Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies

Terminated·BBioMed Valley Discoveries, Inc·Phase 2·NCT05221320·47 enrolled

Gliomas1 trial

Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05804227·40 enrolled

Histiocytic Neoplasms1 trial

Phase 2 Trial of Ulixertinib for Patients With Histiocytic Neoplasms

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06411821·38 enrolled

Metastatic Colorectal Cancer1 trial

Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05985954·27 enrolled

Tumor, Solid1 trial

Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma

Recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT03454035·45 enrolled

Myelofibrosis1 trial

A Phase 1/2 Study of Combined JAK/ERK Inhibition in Patients With Myelofibrosis

Recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT06773195·37 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Ulixertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ulixertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ulixertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — National Cancer Institute (NCI) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: NNational Cancer Institute (NCI)

Ulixertinib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Advanced Lymphoma2 trials

Advanced Malignant Solid Neoplasm2 trials

Malignancies1 trial

Advanced Malignancies1 trial

Adenocarcinoma1 trial

Gastrointestinal1 trial

Gliomas1 trial

Histiocytic Neoplasms1 trial

Metastatic Colorectal Cancer1 trial

Tumor, Solid1 trial

Myelofibrosis1 trial

References

Drug Info

Quick Facts

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