The researchers are doing this study to find out whether the combination of ruxolitinib and ulixertinib is a safe and effective treatment for people with myelofibrosis. The researchers will test different doses of ulixertinib to find the highest dose that causes few or mild side effects in participants when given in combination with ruxolitinib.

Start Date07 Jan 2025

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+2]

NCT06411821

/ RecruitingPhase 2IIT

Phase 2 Trial of Ulixertinib for Patients With Histiocytic Neoplasms

The researchers are doing this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.

Start Date07 May 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT05985954

/ RecruitingPhase 1IIT

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

To find the recommended dose of ulixertinib that can be given in combination with cetuximab and/or encorafenib to patients with unresectable/metastatic CRC and who have received EGFR or BRAF-directed therapy in the past.

Start Date18 Jan 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

100 Clinical Results associated with Ulixertinib

100 Translational Medicine associated with Ulixertinib

100 Patents (Medical) associated with Ulixertinib

135

Literatures (Medical) associated with Ulixertinib

31 Dec 2025·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Advances in ERK1/2 inhibition: a medicinal chemistry perspective on structure and regulation

Review

Author: Emwas, Abdul-Hamid ; Jaremko, Mariusz ; Singh, Ankit Kumar ; Sah, Vimlendu Kumar ; Verma, Amita ; Kumar, Adarsh ; Kumar, Pradeep ; Prajapati, Vineet ; Kalsi, Amandeep Singh ; Khalilullah, Habibullah

The mitogen-activated protein kinase (MAPK) pathway-also known as the RAS/RAF/MEK/ERK pathway-is a critical signalling cascade involved in regulating cell growth, proliferation, and survival. First discovered in the early 1980s, the pathway's extracellular signal-regulated kinase (ERK) subfamily was identified in the 1990s. The ERK family includes several isoforms-ERK1, ERK2, ERK3, ERK5, and ERK6-with ERK1 (MAPK3) and ERK2 (MAPK1) being the most well-characterised and playing central roles in MAPK signalling. Deregulation of ERK signalling (commonly referred to as the ERK pathway or ERKp) has been implicated in approximately 40% of human cancers. This review focuses on the structural insights of ERK1/2 and their critical role in the MAPK signalling cascade. Despite their clinical significance, no ERK inhibitors have yet been approved by the FDA. Several molecules-such as SCH772984, SCH900353, ulixertinib (BVD-523), CC-9003, KO-947, AZD0364, norathyriol, and FR180204-are currently in preclinical or clinical trial stages. This review also highlights recent advances in the design and synthesis of ERK inhibitors, emphasising their structural uniqueness and potential to inhibit mutant forms of ERK1/2. Finally, we discuss future directions for the development of ERK1/2 inhibitors as FDA-approved cancer therapeutics.

01 Dec 2025·CANCER LETTERS

RAD21-mediated epigenetic regulation promotes lung adenocarcinoma progression and sensitizes cancer cells to ERK-targeted therapy

Article

Author: Deng, Ziqin ; He, Jie ; Fan, Tao ; Yin, Hongfei ; Cai, Wenpeng ; Wang, Di ; Liao, Tianle ; Xiao, Chu ; Li, Chunxiang ; Liu, Yixiao ; Li, Jia ; Ji, Yu

The cohesin complex, a critical chromatin organizer and transcriptional regulator, is pivotal in oncogenesis. In lung adenocarcinoma (LUAD), its core subunit RAD21 is frequently amplified and overexpressed. However, its functional mechanisms and potential in targeted-therapy improvement remain elusive. Here, survival analysis and immunohistochemistry revealed that high RAD21 protein levels correlate with poor patient prognosis. Genetic depletion of RAD21 suppressed LUAD cell proliferation by inducing cell cycle arrest and apoptosis, while significantly reducing metastatic capacity both in vitro and in vivo. Integrated transcriptome sequencing (RNA-seq) and chromatin immunoprecipitation sequencing (ChIP-seq) analysis demonstrated that RAD21 occupies genomic regions of genes linked to MAPK signaling and metastasis. RAD21 depletion repressed epithelial-mesenchymal transition (EMT), focal adhesion, and MAPK/ERK cascade activation. RAD21 further modulated H3K4me3 chromatin modification, inducing widespread transcriptional dysregulation of cancer-associated genes. Pharmacological ERK inhibition with ulixertinib effectively reversed RAD21-driven metastasis, particularly in KRAS-mutant contexts. Our findings establish RAD21-mediated epigenetic regulation as a novel mechanism driving LUAD progression. The efficacy of ulixertinib in suppressing cancer metastasis in preclinical models highlights its translational potential for LUAD therapy.

01 Jan 2026·CANCER CELL

RAF-independent MEK mutations drive refractory histiocytic neoplasms but respond to ERK inhibition

Article

Author: Weis, Kenyon ; Daniyan, Anthony F. ; Hanoun, Maher ; Terriou, Louis ; Young, Robert ; Mahajan, Sonia ; Reiner, Anne S. ; Rahman, Jahan ; Zhang, Pu ; Yoo, Sarah ; Singer, Michael ; Benbarche, Salima ; Abdel-Wahab, Omar ; Fox, Nina ; Haroche, Julien ; Emile, Jean-Francois ; Hershkovitz-Rokah, Oshrat ; De Lassus, Laure Farnault ; Rosenblum, Marc ; Chen, Luke Y.C. ; Sosa, Gabriela ; Maron, Maxim I. ; Rotemberg, Veronica ; Francis, Jasmine H. ; Tittley, Steven ; Rampal, Raajit K. ; Petrova-Drus, Kseniya ; Schleinitz, Nicolas ; Hatzoglou, Vaios ; Bossert, Dana ; Cuibus, M. Adriana ; Diamond, Eli L. ; Fujino, Takeshi ; Yabe, Mariko ; Shpilberg, Ofer ; Durham, Benjamin H. ; Hautala, Timo ; Cohen-Aubart, Fleur ; Rosen, Neal ; Witkowski, Matthew ; Castro, Cynthia ; Lewis, Alexander M. ; Rösler, Wiebke ; Mazor, Roei D. ; Ulaner, Gary A.

Histiocytic neoplasms are clonal disorders of the monocyte/macrophage lineage defined by mutations activating mitogen-activated protein kinase (MAPK) signaling. Recently, the MEK1/2 inhibitor cobimetinib was FDA-approved for patients with adult histiocytoses. Here, aided by a prospective registry of patients with histiocytoses (NCT03329274), we identify that MEK1/2 mutations which constitutively activate MEK independently of RAF are associated with worse progression-free survival with MEK1/2 inhibition as compared to patients with other MEK1/2 mutational classes. The most common RAF-independent MEK1 mutation (MEK1^E102_I103del) drove a lethal histiocytic-like neoplasm in mice, which was sensitive to the ERK1/2 inhibitor ulixertinib. We subsequently treated five MEK1^E102_I103del-mutant patients with ulixertinib on prospective protocols, four of whom were refractory to MEK inhibition. Four of five patients experienced objective responses to ulixertinib. These data reveal the impact of oncogenic MEK mutations in vivo, identify patients with likelihood of resistance to MEK inhibition, and nominate ERK inhibition to overcome resistance to MEK inhibition in histiocytoses.

News (Medical) associated with Ulixertinib

12 Sep 2022

·www.prnewswire.com

BioMed Valley Discoveries Announces First Patient Dosed in Phase II Combination Trial with Ulixertinib (BVD-523), its First-in-Class and Best-in-Class ERK Inhibitor, in Combination with Hydroxychloroquine

KANSAS CITY, Mo., Sept. 12, 2022 /PRNewswire/ -- BioMed Valley Discoveries (BVD) announced that the first patient has been dosed in a phase II clinical trial of ulixertinib (BVD-523) in combination with hydroxychloroquine (HCQ). Ulixertinib is a first-in-class and best-in-class ERK inhibitor, with this clinical trial focusing on patients with advanced gastrointestinal malignancies and mutations in the MAPK pathway. This study builds upon the finding of the phase I study of the combination, which was completed at Huntsman Cancer Institute at the University of Utah. "Combining an ERK inhibitor with an autophagy inhibitor is anticipated to take advantage of the finding that tumors may become addicted to autophagy for survival in context of MAPK inhibition" said Brent Kreider, Ph.D., President of BioMed Valley Discoveries. "Given the favorable safety profile and efficacy seen with ulixertinib monotherapy, we believe that the combination with hydroxychloroquine has the potential to provide significant benefit to patients with advanced gastrointestinal malignancies." The Phase II efforts build on a successful Phase Ib evaluating ulixertinib monotherapy as a novel targeted cancer treatment in cohorts of patients with genetic alterations that result in aberrant MAPK pathway signaling. Results from phase Ib demonstrated ulixertinib has an acceptable safety profile and early evidence of clinical activity against a wide range of RAS/MAPK pathway-driven cancers, including atypical alterations in BRAF. In addition to targeting the terminal node of the RAS/MAPK pathway, ulixertinib's highly selective kinase inhibition profile is expected to provide potential impact across a number of tumor types in both monotherapy and combination. Previous efforts have also established a recommended phase 2 dose in combination with palbociclib, with additional combination efforts ongoing. About ulixertinib (BVD-523): Ulixertinib is a first-in class and best-in class small molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug. ERK kinases are downstream components of the mitogen-activated protein kinase (MAPK) signaling cascade (RAS-RAF-MEK-ERK). Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway. About the study: This is an open-label, multicenter, prospective phase II basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients recruited must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages and includes pancreatic, colorectal, esophageal, gastric and cholangiocarcinomas . (Clinicaltrials.gov Number NCT05221320). About BioMed Valley Discoveries (BVD): BioMed Valley Discoveries is a clinical stage biotechnology company focused on addressing unmet medical needs in a variety of therapeutic and diagnostic areas. In addition to the ERK inhibitor, BVD's portfolio includes an oncolytic bacteria that has completed enrollment for a Phase I study, and two early-stage antibodies targeting the tumor microenvironment. Operating since 2007, BioMed Valley Discoveries was established by Jim Stowers Jr., founder of the asset management firm American Century Investments, and his wife Virginia, to advance new medical innovations to improve the lives of patients with difficult-to-treat diseases. BVD is owned by a supporting organization of the Stowers Institute for Medical Research, a non-profit, basic biomedical research organization. Since 2000, the endowment of the Stowers Institute has received over $1.7 billion in dividend payments from American Century. The Institute has invested a portion of its endowment in BVD, whose profits accrue to the benefit of the Institute. For more information, visit . Media Contact Joe Chiodo, Head of Media Relations 724-462-8529 [email protected] SOURCE BioMed Valley Discoveries

AntibodyCollaborateFirst in ClassSmall molecular drug

06 Jan 2021

·www.biospace.com

Theralink® Technologies Issues Letter to Shareholders

DENVER, Jan. 6, 2021 /PRNewswire/ -- Theralink Technologies (OTC: OBMP) ("Theralink" or the "Company"), a molecular profiling company specializing in patented, biomarker assay services that target multiple areas of oncology, today issued a letter to shareholders from its President and CEO, Mick Ruxin, M.D., providing a 2020 year-end recap and vision for the path ahead in 2021. Dear Shareholders: 2020 was a transformative year for Theralink Technologies. In June, we successfully closed OncBioMune Pharmaceuticals' asset purchase of Avant Diagnostics and changed the corporate name to Theralink® Technologies Inc. In September, Theralink emerged as a proteomics-based, molecular profiling and precision medicine company targeting multiple areas of oncology and drug development. Going forward we will continue to work on several other key aspects of our evolution as a public company, including our stock symbol change and updated financial statements with the SEC, which we anticipate to all be completed during the first half of 2021. In addition to my appointment as President and CEO, we have added experienced professionals to our leadership team through three key hires. We welcomed Kris Weinberg as Director of Commercial Oncology Markets, Michael Fanelli as Senior Director of Biopharma Commercial Operations and Tom Chilcott as Chief Financial Officer, who all bring extensive experience in their respective fields and have hit the ground running as part of our team. Over the past six-months, we have worked diligently to lay the foundation for our growth in 2021. Notably, we received Clinical Laboratory Improvement Amendments (CLIA) certification for our Golden, Colorado laboratory, which took two years to achieve. CLIA certification enables us to expand our testing capabilities and we will soon begin receiving, testing and billing for patient's breast cancer tumor specimens. As part of our growth strategy ahead, we have established several strategic agreements: In July, we announced a multi-year strategic agreement with VieCure™, the developer of the proprietary VieCure™ platform, a real-time decision-support system that combines clinical knowledge with patient data to assist oncologists in generating personalized treatment plans and managing a patient's care throughout his or her cancer therapy. Through our agreement, VieCure's physician network has access to Theralink's generation of testing for cancer patients, extending VieCure™'s genomics platform to now include phosphoprotein and protein-based information. We believe that the potential reach of their physician network leveraging our assay is substantial. In September, we announced our translational research collaboration with BioMed Valley Discoveries (BVD) to provide Laser Capture Microdissection (LCM) and Reverse Phase Protein Array (RPPA) services to assist BVD with translational research. We believe that this research could potentially improve treatment outcomes and quality of life for all cancer patients. In November 2020, we announced our agreement with Perthera, a market leader in Precision Oncology technology and services whose platform has been utilized by over 250 cancer care sites. The alliance was formed to facilitate and accelerate access to Theralink's 32 phosphoprotein panel, the Theralink® assay, across Perthera's wide reach in the U.S. for breast cancer patients and the oncologists who treat them. With many key milestones under our belt for 2020, there remains no shortage of opportunity as we head into 2021. In addition to the signing of our translational research collaboration with BioMed Valley Discoveries in September 2020, we have successfully signed multiple other biopharma collaboration agreements to date, all of which are generating revenue. In 2021, we not only expect to expand these existing relationships, but we will also continue to sign multiple other collaborative agreements. Thank you for your continued support and commitment. The Theralink team looks forward to a prosperous 2021! Sincerely, Mick Ruxin, M.D. President and CEO Corporate Milestones: OncBioMune Pharmaceuticals closed the asset purchase of Avant Diagnostics in June 2020 - link In September 2020, the Company received Clinical Laboratory Improvement Amendments (CLIA) certification for its Golden, Colorado laboratory, retroactively effective as of January 8, 2020 – link As of Thursday, September 24, 2020 the Company completed its corporate name change to Theralink Technologies, Inc. – link Enhanced Leadership: In June 2020, we appointed Mick Ruxin, M.D. as President & CEO and Jeffrey Busch as Chairman of the Board – link Also In June 2020, we appointed Kris Weinberg as Director, Oncology Commercial Markets. Mr. Weinberg has 20 years of experience in the commercial aspects of cancer molecular diagnostics, leading the launch and adoption of oncology assays including OncoType Dx and Guardant 360. Prior to TheraLink, he was commercial lead for TGen's CLIA NGS laboratory (Ashion) and Natera's oncology division. Also, Mr. Weinberg has previous public company experience at IMPATH, Genomic Health and Guardant Health. In July 2020, we appointed Michael Fanelli as Senior Director of Biopharma Commercial Operations – link In September 2020, we appointed Thomas E. Chilcott, III CPA as Chief Financial Officer – link Strategic Agreements: In July 2020, the Company signed a mutli-year strategic agreement with VieCure™ to enhance personalized cancer treatment in community oncology settings – link In September 2020, the Company announced its translational research collaboration with BioMed Valley Discoveries (BVD) to provide Laser Capture Microdissection (LCM) and Reverse Phase Protein Array (RPPA) services to assist BVD with translational research pertaining to first-in-class and best-in-class ERK 1/2 Inhibitor – Ulixertinib (BVD-523) – link In November 2020, the Company announced its agreement with Perthera, a market leader in Precision Oncology technology and services. The alliance was formed to facilitate and accelerate access to Theralink's 32 phosphoprotein panel, the Theralink assay, across the U.S. for breast cancer patients – link About Theralink Technologies, Inc. Theralink® Technologies is a proteomics-based, molecular profiling and precision medicine company with a CLIA-certified laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink's technology targets multiple areas of oncology and drug development. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array (RPPA) assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity. For more information, please visit . Forward-Looking Statements Certain statements contained in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, anything relating or referring to future financial results, patient enrollment and plans for future business development activities, and are thus prospective. Forward-looking statements are inherently subject to risks and uncertainties some of which cannot be predicted or quantified based on current expectations. Such risks and uncertainties include, without limitation, the risks and uncertainties set forth from time to time in reports filed by Theralink Technologies with the Securities and Exchange Commission. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business and although the company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. Consequently, future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward the forward-looking statements contained herein. The company undertakes no obligation to publicly release statements made to reflect events or circumstances after the date hereof. Company Codes: OTC-PINK:OBMP

CollaborateFinancial StatementFirst in Class

100 Deals associated with Ulixertinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11038	-	-	DB13930

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Post-essential thrombocythemia myelofibrosis	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 Jan 2025
Post-polycythemia vera myelofibrosis	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 Jan 2025
Diffuse Large B-Cell Lymphoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 May 2024
Hematologic Neoplasms	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 May 2024
Histiocytoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 May 2024
Adenocarcinoma of Esophagus	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022
Adenocarcinoma of large intestine	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022
Esophageal Squamous Cell Carcinoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022
Gastroesophageal junction adenocarcinoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022
Intrahepatic Cholangiocarcinoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03454035 (ESMO2025)	Phase 1	Metastatic melanoma N(K,H)RAS G12/G13/Q61-mut \| NF1 loss-of-function mutant	9	Ulixertinib plus palbociclib	kpynyepgja(utneeiphfh) = RRAE of any grade occurring in >=4 pts were rash, serum creatinine increase, fatigue, diarrhea, anemia, vomiting, thrombocytopenia, and neutropenia, resulting in dose reduction in 7 pts. Serious (grade >=3) RRAE occurring in >=3 patients were neutropenia and rash. bfpjwbpglp (pkuwcftkni )	Positive	17 Oct 2025
NCT04488003 (CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	104	Ulixertinib	sezpzobojv = xsvkuiqewf zvyrjqambc (lzkjltfacu, mphfoshzmz - kcijhegyox) View more	-	04 Jun 2024
NCT06400225 (MATCH - Subprotocol Z1L, Pubmed)	Phase 2	Central Nervous System Neoplasms	20	优立替尼	utalqejwfy(hwulbvdrlh) = jntsxnoday zddiidtcdz (voqftzsgdp )	Positive	01 Jun 2024
NCT03698994 (CTgov)	Phase 2	Refractory Soft Tissue Sarcoma \| Refractory Histiocytic and Dendritic Cell Neoplasm \| Recurrent Medulloblastoma ... View more	20	Pharmacokinetic Study+Ulixertinib	nnfyhsbwbr = emuwiichtb punmsgbzqz (apgzgylvkt, dtdvgzqazx - vpqlmqhwwf) View more	-	16 May 2023
NCT02608229 (Pubmed \| Oncologist) Manual	Phase 1	Pancreatic adenocarcinoma metastatic	18	Albumin-Bound Paclitaxel+Gemcitabine+Ulixertinib	nbfxrxkpkj(qgvuqfhnbj) = ulixertinib 450 mg BID ouzdrybese (otbrazhpzx )	Positive	25 Nov 2022
NCT02465060 (EAY131-Z1L, AACR2022) Manual	Phase 1	Neoplasms BRAF Fusion	35	BVD-523FB	dmqyejkzoz(baymoxlddl) = ivaxrmulww mjahlchlah (xtbzyvtymr ) View more	Positive	15 Jun 2022
NCT03698994 (ASCO2022) Manual	Phase 2	Neoplasms MAPK Mutation	20	overall	ycragfgrde(ebwabyozdl) = hqofwrinwj encszvgxvv (vgpoyupyww, 17 - 58) View more	Positive	02 Jun 2022
NCT03698994 (ASCO2022) Manual	Phase 2	Neoplasms MAPK Mutation	20	Ulixertinib 260 mg/m2 (DL1)	aeakfvmbki(fyplqbxgth) = qqqjankaov jhpbodjagt (zsyzktssee )	Positive	02 Jun 2022
NCT04566393 (ULI-EAP-100, ASCO2022) Manual	Not Applicable	HR-positive/HER2-low Solid Tumors MAPK Mutation	48	ulixertinib	xyuxcllmqw(vcnkfudjqa) = zyeefkdwnt kulanlmzrp (jsbvwfwkun ) View more	Positive	02 Jun 2022
NCT03417739 (CTgov)	Phase 2	Uveal Melanoma	13	BVD-523	zhyththtvx = nvizsslirj krpjekcxxw (wqctplhcar, afrrgjfqpu - afwuenuekf) View more	-	11 Nov 2021
NCT03454035 (ASCO2021)	Phase 1	HR-positive/HER2-low Solid Tumors	26	Ulixertinib 300mg BID + Palbociclib 75mg daily	fdlpzftvaf(zcyahmylal) = xzfxcfwkwt aubbeisxtb (tpxawmzwmh, 1.87 - notdetermined)	-	28 May 2021

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