CX-5461 (Pidnarulex) Clinical Trials

Size	Price	Qty
5mg	USD 270
50mg	USD 970

Clinical Trials

Multiple Phase I and Phase Ib/II clinical trials evaluate CX-5461 (Pidnarulex) as monotherapy or combination therapy across diverse oncological indications, including advanced solid tumors, breast carcinoma, colorectal cancer, MYC-aberrant lymphomas, and metastatic castration-resistant prostate cancer. Sponsored by academic medical centers, industry partners such as Senhwa Biosciences, the National Cancer Institute, and the Canadian Cancer Trials Group, these completed, recruiting, and suspended studies assess safety, pharmacodynamics, and efficacy across specific genetic mutations and tumor subtypes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07069699	RECRUITING	Burkitt Lymphoma; Double-Expressor Lymphoma; High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements	National Cancer Institute (NCI)	2026-10-13	PHASE1; PHASE2
NCT07137416	RECRUITING	Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Invasive Breast Carcinoma; Locally Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Metastatic HER2-Low Breast Carcinoma; Metastatic HER2-Positive Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Triple-Negative Breast Carcinoma; Unresectable Breast Carcinoma; Unresectable HER2-Low Breast Carcinoma; Unresectable HER2-Positive Breast Carcinoma; Unresectable Hormone Receptor-Positive Breast Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Triple-Negative Breast Carcinoma	National Cancer Institute (NCI)	2026-10-05	PHASE1
NCT07147231	RECRUITING	Metastatic Colorectal Adenocarcinoma; Refractory Colorectal Adenocarcinoma; Stage III Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Unresectable Colorectal Adenocarcinoma	National Cancer Institute (NCI)	2026-08-10	PHASE1; PHASE2
NCT04890613	RECRUITING	Advanced Solid Tumor	Senhwa Biosciences, Inc.	2021-09-08	PHASE1
NCT06606990	RECRUITING	Metastatic Malignant Solid Neoplasm	National Cancer Institute (NCI)	2025-07-01	PHASE1
NCT05425862	SUSPENDED	Metastatic Castration Resistant Prostate Cancer (mCRPC)	Peter MacCallum Cancer Centre, Australia	2022-10-21	PHASE1
NCT02719977	COMPLETED	Cancer	Canadian Cancer Trials Group	2016-06-13	PHASE1
NCT02719977	Completed	Cancer	Canadian Cancer Trials Group\|Senhwa Biosciences Inc.\|Stand Up To Cancer	2016-06-13	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-31)

Check the CX-5461 (Pidnarulex) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CX-5461 selectively binds and inhibits RNA polymerase I, disrupting pre-ribosomal RNA synthesis, pre-initiation complex assembly, and SL1-rDNA interactions without affecting RNA polymerase II activity or general protein translation. This targeted disruption of nucleolar ribosomal biogenesis triggers nucleolar stress and induces cellular autophagy, ultimately inhibiting cancer cell proliferation across diverse malignancies such as advanced solid tumors, breast carcinoma, and lymphomas evaluated in clinical trials.

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>).