Ozmosi | Ulixertinib Drug Profile
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Ulixertinib

Pronounced as: yoo-lik-SER-ti-nib

Alternative Names: ulixertinib, bvd-523
Clinical Status: Active
Latest Update: 2026-01-16
Latest Update Note: Clinical Trial Update

Product Description

An orally available inhibitor of extracellular signal-regulated kinase (ERK) 1 and 2, with potential antineoplastic activity. Upon oral administration, ulixertinib inhibits both ERK 1 and 2, thereby preventing the activation of ERK-mediated signal transduction pathways. This results in the inhibition of ERK-dependent tumor cell proliferation and survival. The mitogen-activated protein kinase (MAPK)/ERK pathway is often upregulated in a variety of tumor cell types and plays a key role in tumor cell proliferation, differentiation and survival. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ulixertinib)

Mechanisms of Action: ERK Inhibitor, ERK Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: BioMed Valley Discoveries
Company Location: Western America
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Ulixertinib

Countries in Clinic: United States

Active Clinical Trial Count: 6

Recent & Upcoming Milestones

Highest Development Phases

Phase 2: Myelofibrosis|Oncology Unspecified|Uveal Melanoma

Phase 1: Colorectal Cancer|Glioma|Melanoma|Pancreatic Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05985954

NCI-2023-06254

P1

Recruiting

Colorectal Cancer

2028-03-28

2%

2024-08-27

Primary Completion Date|Primary Endpoints

NCT05804227

NCI-2023-02713

P1

Recruiting

Glioma

2027-09-22

50%

2025-12-27

Primary Completion Date|Primary Endpoints

NCT03454035

LCCC1736

P1

Recruiting

Melanoma|Pancreatic Cancer

2026-07-15

2%

2025-09-12

Primary Completion Date|Primary Endpoints|Treatments

NCT06773195

NCT06773195

P2

Recruiting

Myelofibrosis

2028-01-01

50%

2025-01-15

Primary Endpoints

NCT06411821

NCT06411821

P2

Recruiting

Oncology Unspecified

2027-05-01

12%

2024-05-15

Primary Endpoints|Treatments

NCT03417739

NCT03417739

P2

Active, not recruiting

Uveal Melanoma

2020-05-05

20%

2021-11-12

Primary Endpoints|Treatments