Clinical Trials

Numerous clinical trials, primarily sponsored by EpicentRx, Inc., are evaluating RRx-001 as a monotherapy or combination therapy across Phase 1 through Phase 3 studies. The clinical program targets conditions including small cell lung carcinoma, glioblastoma, metastatic colorectal neoplasms, brain metastases, oral mucositis, and pediatric central nervous system tumors. Across these recorded studies, recruitment statuses encompass active, completed, not recruiting, and terminated trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05966194 ACTIVE_NOT_RECRUITING
Oral Mucositis
EpicentRx, Inc.
 2024-04-02 PHASE2
NCT05566041 ACTIVE_NOT_RECRUITING
Carcinoma, Small Cell Lung
EpicentRx, Inc.
 2022-08-01 PHASE3
NCT04525014 TERMINATED
Brain Tumor, Recurrent; Brain Tumor, Pediatric; Central Nervous System Neoplasms; Unspecified Childhood Solid Tumor, Protocol Specific
EpicentRx, Inc.
 2023-01-26 PHASE1
NCT03699956 TERMINATED
Carcinoma, Small Cell Lung
EpicentRx, Inc.
 2018-12-24 PHASE3
NCT02489903 COMPLETED
Small Cell Carcinoma; Carcinoma, Non-Small-Cell Lung; Neuroendocrine Tumors; Ovarian Epithelial Cancer
EpicentRx, Inc.
 2015-06 PHASE2
NCT03515538 COMPLETED
Oral Mucositis
EpicentRx, Inc.
 2018-07-12 PHASE2
NCT02871843 COMPLETED
Glioblastoma; Oligodendroglioma; Anaplastic Oligodendroglioma
EpicentRx, Inc.
 2017-02-14 PHASE1
NCT02801097 TERMINATED
Malignant Solid Tumor; Metastatic Cancer; Advanced Cancer
EpicentRx, Inc.
 2016-08-30 PHASE1
NCT02096354 COMPLETED
Colorectal Neoplasms
EpicentRx, Inc.
 2014-05 PHASE2
NCT02215512 COMPLETED
Brain Metastases
EpicentRx, Inc.
 2015-02-06 PHASE1
NCT02518958 COMPLETED
Malignant Solid Tumor; Lymphoma
EpicentRx, Inc.
 2015-07-21 PHASE1
NCT02452970 TERMINATED
Cholangiocarcinoma
EpicentRx, Inc.
 2015-07-16 PHASE2
NCT02096341 TERMINATED
Malignant Solid Tumor; Lymphomas
EpicentRx, Inc.
 2014-04 PHASE1
NCT01359982 COMPLETED
Malignant Solid Tumor; Lymphomas
EpicentRx, Inc.
 2011-09 PHASE1
NCT02096341 Terminated
Malignant Solid Tumor|Lymphomas
EpicentRx Inc.
 2014-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-26)

Check the RRx-001 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RRx-001 inhibits glucose-6-phosphate dehydrogenase and downregulates the CD47-SIRPα checkpoint while driving hemoglobin-mediated redox reactions under hypoxia, thereby disrupting pentose phosphate pathway flux and inducing tumor cell apoptosis. This targeted metabolic perturbation and immunomodulatory activity provide the biological rationale for its clinical investigation in solid tumors, including small cell lung cancer, glioblastoma, and metastatic colorectal cancer.

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.