Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of Silmitasertib (CX-4945) across Phase 1, Phase 2, and combined Phase 1/2 protocols for conditions including COVID-19, viral pneumonia, pediatric medulloblastoma, cholangiocarcinoma, basal cell carcinoma, and advanced solid tumors. Sponsored by biotechnology firms such as Senhwa Biosciences Inc. alongside academic and government entities like the National Cancer Institute, these studies feature recruitment statuses ranging from completed and recruiting to suspended or terminated.

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) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Silmitasertib (CX-4945) is a potent, ATP-competitive inhibitor of protein kinase CK2 that attenuates downstream PI3K/Akt signaling through Akt dephosphorylation and suppresses hypoxia-inducible factor 1-alpha (HIF-1α) transcription. This biochemical pathway disruption blocks endothelial cell migration and induces cell-cycle arrest and apoptosis, underpinning its clinical investigation in oncology indications like cholangiocarcinoma and medulloblastoma as well as viral respiratory infections.

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.