Ulixertinib (BVD-523) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 447

Clinical Trials

Ulixertinib (BVD-523) has been evaluated in numerous Early Phase I, Phase I, and Phase II clinical trials targeting MAPK pathway-altered malignancies, including advanced solid tumors, gastrointestinal adenocarcinomas, uveal melanoma, histiocytic neoplasms, and pediatric refractory solid tumors harboring BRAF, MEK, or KRAS mutations. Sponsored by industry, government, and academic institutions such as BioMed Valley Discoveries, the National Cancer Institute, Dana-Farber Cancer Institute, and M.D. Anderson Cancer Center, these investigations encompass recruiting, active not recruiting, completed, and terminated statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05985954	RECRUITING	Metastatic Colorectal Cancer	M.D. Anderson Cancer Center	2024-01-18	PHASE1
NCT03454035	RECRUITING	Tumor, Solid; Pancreatic Cancer; Melanoma	UNC Lineberger Comprehensive Cancer Center	2018-01-30	PHASE1
NCT06773195	RECRUITING	Myelofibrosis	Memorial Sloan Kettering Cancer Center	2025-01-07	PHASE1; PHASE2
NCT05804227	RECRUITING	Gliomas	M.D. Anderson Cancer Center	2023-04-20	EARLY_PHASE1
NCT06411821	RECRUITING	Histiocytic Neoplasms	Memorial Sloan Kettering Cancer Center	2024-05-07	PHASE2
NCT02465060	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma	National Cancer Institute (NCI)	2015-08-17	PHASE2
NCT06400225	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma	National Cancer Institute (NCI)	2019-07-24	PHASE2
NCT03155620	ACTIVE_NOT_RECRUITING	Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor	National Cancer Institute (NCI)	2017-07-31	PHASE2
NCT05221320	TERMINATED	Tumor, Solid; Gastrointestinal Cancer	BioMed Valley Discoveries, Inc	2022-05-26	PHASE2
NCT04488003	TERMINATED	Advanced Solid Tumor; BRAF Gene Mutation; BRAF Gene Alteration; MEK Mutation; MEK Alteration; MAP2K1 Gene Mutation; MAP2K1 Gene Alteration; MAP2K2 Gene Mutation; MAP2K2 Gene Alteration	BioMed Valley Discoveries, Inc	2021-01-07	PHASE2
NCT04145297	COMPLETED	Gastrointestinal Neoplasms	University of Utah	2020-03-17	PHASE1
NCT03698994	ACTIVE_NOT_RECRUITING	Advanced Malignant Solid Neoplasm; Recurrent Ependymal Tumor; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Histiocytic and Dendritic Cell Neoplasm; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Malignant Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Refractory Ependymoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Histiocytic and Dendritic Cell Neoplasm; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Malignant Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Refractory Soft Tissue Sarcoma; Wilms Tumor	National Cancer Institute (NCI)	2018-11-14	PHASE2
NCT04488003	Terminated	Advanced Solid Tumor\|BRAF Gene Mutation\|BRAF Gene Alteration\|MEK Mutation\|MEK Alteration\|MAP2K1 Gene Mutation\|MAP2K1 Gene Alteration\|MAP2K2 Gene Mutation\|MAP2K2 Gene Alteration	BioMed Valley Discoveries Inc	2020-11-03	Phase 2
NCT03417739	TERMINATED	Uveal Melanoma	Dana-Farber Cancer Institute	2018-03-26	PHASE2
NCT04145297	Completed	Gastrointestinal Neoplasms	University of Utah\|BioMed Valley Discoveries Inc	2020-03-17	Phase 1
NCT02608229	TERMINATED	Pancreatic Cancer; Cancer of Pancreas; Cancer of the Pancreas; Pancreas Cancer	Washington University School of Medicine	2016-06-06	PHASE1
NCT03698994	Active not recruiting	Advanced Malignant Solid Neoplasm\|Recurrent Ependymal Tumor\|Recurrent Ewing Sarcoma\|Recurrent Glioma\|Recurrent Hepatoblastoma\|Recurrent Histiocytic and Dendritic Cell Neoplasm\|Recurrent Langerhans Cell Histiocytosis\|Recurrent Malignant Germ Cell Tumor\|Recurrent Malignant Solid Neoplasm\|Recurrent Medulloblastoma\|Recurrent Neuroblastoma\|Recurrent Non-Hodgkin Lymphoma\|Recurrent Osteosarcoma\|Recurrent Peripheral Primitive Neuroectodermal Tumor\|Recurrent Primary Malignant Central Nervous System Neoplasm\|Recurrent Rhabdoid Tumor\|Recurrent Rhabdomyosarcoma\|Recurrent Soft Tissue Sarcoma\|Refractory Ependymoma\|Refractory Ewing Sarcoma\|Refractory Glioma\|Refractory Hepatoblastoma\|Refractory Histiocytic and Dendritic Cell Neoplasm\|Refractory Langerhans Cell Histiocytosis\|Refractory Malignant Germ Cell Tumor\|Refractory Malignant Solid Neoplasm\|Refractory Medulloblastoma\|Refractory Neuroblastoma\|Refractory Non-Hodgkin Lymphoma\|Refractory Osteosarcoma\|Refractory Peripheral Primitive Neuroectodermal Tumor\|Refractory Primary Malignant Central Nervous System Neoplasm\|Refractory Rhabdoid Tumor\|Refractory Rhabdomyosarcoma\|Refractory Soft Tissue Sarcoma\|Wilms Tumor	National Cancer Institute (NCI)	2018-11-14	Phase 2
NCT03417739	Active not recruiting	Uveal Melanoma	Dana-Farber Cancer Institute\|BioMed Valley Discoveries Inc	2018-03-26	Phase 2
NCT01781429	COMPLETED	Advanced Solid Tumors	BioMed Valley Discoveries, Inc	2013-03	PHASE1; PHASE2
NCT02296242	COMPLETED	Acute Myelogenous Leukemia; Myelodysplastic Syndrome	BioMed Valley Discoveries, Inc	2014-11	PHASE1; PHASE2
NCT02994732	COMPLETED	Healthy	BioMed Valley Discoveries, Inc	2017-01	PHASE1
NCT02994732	Completed	Healthy	BioMed Valley Discoveries Inc	2017-01	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-03-12)

Check the Ulixertinib (BVD-523) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ulixertinib acts as a potent, reversible inhibitor of ERK1 and ERK2 that binds to the kinase active site, thereby blocking downstream phosphorylation of key transcriptional targets within the MAPK cascade. This target inhibition halts cell proliferation and triggers apoptotic cell death, demonstrating clinical relevance by inhibiting tumor growth in solid malignancies possessing hyperactivating BRAF or MEK alterations.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).