Clinical Trials

Silmitasertib (CX-4945) has been evaluated in several clinical trials across Phase I, Phase II, and Phase I/II studies. These trials target viral respiratory infections, including COVID-19 and community-acquired pneumonia, alongside oncological malignancies such as cholangiocarcinoma, pediatric medulloblastoma, advanced solid tumors, and multiple myeloma. Sponsored by commercial entities like Senhwa Biosciences and academic consortia including the National Cancer Institute, these studies span completed, recruiting, suspended, and terminated statuses to establish the agent's safety and therapeutic utility.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06541262 RECRUITING
Neuroblastoma; Ewing Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Liposarcoma
Milton S. Hershey Medical Center
 2024-10-30 PHASE1; PHASE2
NCT03904862 TERMINATED
Medulloblastoma, Childhood; Medulloblastoma Recurrent; Medulloblastoma
Pediatric Brain Tumor Consortium
 2019-07-25 PHASE1; PHASE2
NCT06202521 TERMINATED
Community-acquired Pneumonia; SARS-CoV-2 -Associated Pneumonia; Influenza With Pneumonia
Senhwa Biosciences, Inc.
 2024-03-20 PHASE2
NCT03897036 COMPLETED
Carcinoma, Basal Cell
Senhwa Biosciences, Inc.
 2019-04-16 PHASE1
NCT05817708 COMPLETED
COVID-19
Senhwa Biosciences, Inc.
 2022-11-28 PHASE1
NCT05817708 Completed
COVID-19
Senhwa Biosciences Inc.
 2022-11-07 Phase 1
NCT04668209 TERMINATED
Coronavirus
University of Arizona
 2021-01-21 PHASE2
NCT04663737 COMPLETED
Covid19
Senhwa Biosciences, Inc.
 2020-11-30 PHASE2
NCT04668209 Terminated
Coronavirus
University of Arizona|Senhwa Biosciences Inc.
 2021-01-21 Phase 2
NCT04663737 Completed
Covid19
Chris Recknor MD|Senhwa Biosciences Inc.
 2020-12-03 Phase 2
NCT02128282 COMPLETED
Cholangiocarcinoma
Senhwa Biosciences, Inc.
 2014-06 PHASE1; PHASE2
NCT03904862 Suspended
Medulloblastoma Childhood
Pediatric Brain Tumor Consortium|National Cancer Institute (NCI)|American Lebanese Syrian Associated Charities (ALSAC)
 2019-07-25 Phase 1|Phase 2
NCT02128282 Completed
Cholangiocarcinoma
Senhwa Biosciences Inc.
 2014-06 Phase 1|Phase 2
NCT00891280 UNKNOWN
Advanced Solid Tumors; Breast Cancer; Inflammatory Breast Cancer; Castleman's Disease; Multiple Myeloma
Cylene Pharmaceuticals
 2009-02 PHASE1
NCT01199718 UNKNOWN
Multiple Myeloma
Cylene Pharmaceuticals
 2010-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Silmitasertib (CX-4945) sodium salt product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Silmitasertib selectively binds to and inhibits the catalytic subunits of casein kinase 2 (CK2), thereby disrupting downstream pro-survival signaling cascades, attenuating dysregulated intracellular protein phosphorylation, and suppressing aberrant cell proliferation while inducing programmed cell death. By targeting CK2-mediated pathways critical for malignant progression and host-path взаимодей physiological interactions, this inhibition provides the rationale for evaluating silmitasertib in clinical trials for solid tumors such as cholangiocarcinoma and medulloblastoma, as well as viral infections including COVID-19.

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>).

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Note: Technical data last updated: Sep 1, 2026.