Ulixertinib

Phase 2Small molecule

NNational Cancer Institute (NCI)

Ulixertinib is one of 210 small molecule programs targeting Treatment. It is currently in Phase 2.

Indications

Total Trials

Active Trials

209

Competitors

Pipeline

Status by Indication[3][1]

Indication

TreatmentActive, not recruiting

Advanced LymphomaActive, not recruiting

Advanced Malignant Solid NeoplasmActive, not recruiting

Tumor, SolidRecruiting

Histiocytic NeoplasmsRecruiting

GliomaRecruiting

Tic DisorderActive, not recruiting

MyelofibrosisRecruiting

TreatmentPhase 2

Active, not recruiting

Advanced LymphomaPhase 2

Active, not recruiting

Advanced Malignant Solid NeoplasmPhase 2

Active, not recruiting

Tumor, SolidPhase 1

Recruiting

Histiocytic NeoplasmsPhase 2

Recruiting

GliomaPhase 1

Recruiting

Tic DisorderPhase 2

Active, not recruiting

MyelofibrosisPhase 2

Recruiting

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Ulixertinib

NNational Cancer Institute (NCI)

Phase 2

1 2

Dexilant

Takeda

Preclinical

2 3

Niclocide

Bayer

Preclinical

1 4

Alfenta

Jazz Pharmaceuticals

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Clomid

Ferring

Preclinical

1 8

Lotemax

PPharmos

Preclinical

1 9

Norpramin

VValidus Pharmaceuticals

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Treatment

NCT06400225

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Q1 2027

Phase 2Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT03155620

Q2 2027

Phase 2Recruiting

Histiocytic Neoplasms

NCT06411821

Q3 2027

Phase 1Recruiting

Glioma

NCT05804227

Clinical

Trials by Indication[1]

Adenocarcinoma1 trial

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

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

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

Treatment1 trial

Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L)

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

8 more indications

Glioma1 trial

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

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

Tic Disorder1 trial

Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

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

Histiocytic Neoplasms1 trial

Ulixertinib in People 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

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

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

Advanced Malignant Solid Neoplasm1 trial

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

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

Adenocarcinoma1 trial

Gastrointestinal1 trial

Treatment1 trial

Malignancies1 trial

Advanced Malignancies1 trial

Glioma1 trial

Tic Disorder1 trial

Histiocytic Neoplasms1 trial

Metastatic Colorectal Cancer1 trial

Advanced Lymphoma1 trial

Tumor, Solid1 trial

Myelofibrosis1 trial

Advanced Malignant Solid Neoplasm1 trial

References

Drug Info

Quick Facts

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