Clinical Trials

Multiple clinical trials spanning Phase 1 to Phase 3 have evaluated phenoxodiol across various oncological indications, including prostate cancer, metastatic soft-tissue sarcoma, ovarian, fallopian tube, and primary peritoneal cancers, and advanced solid tumors. Conducted by both academic institutions and pharmaceutical sponsors, these completed and terminated studies assessed safety, dosage escalation, and therapeutic efficacy as monotherapy and in combination with chemotherapy or radiotherapy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05100628 Terminated
Metastatic Soft-tissue Sarcoma
Noxopharm Limited
 2022-02-11 Phase 1
NCT04957290 Terminated
Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
Noxopharm Limited
 2021-10-25 Phase 1|Phase 2
NCT00303888 TERMINATED
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
Yale University
 2006-05 PHASE1
NCT00382811 COMPLETED
Fallopian Tube Cancer; Peritoneal Neoplasms; Ovarian Cancer
MEI Pharma, Inc.
 2006-10 PHASE3
NCT00091377 COMPLETED
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MEI Pharma, Inc.
 2004-08 PHASE1; PHASE2
NCT00557037 Completed
Prostate Cancer
MEI Pharma Inc.
 2007-11 Phase 2
NCT00878800 Completed
Dose Escalation: Solid Tumors|MTD: Soft Tissue Sarcomas
Valerio Therapeutics|Spectrum Pharmaceuticals Inc
 2006-12 Phase 1|Phase 2
NCT00557037 COMPLETED
Prostate Cancer
MEI Pharma, Inc.
 2007-11 PHASE2
NCT00022295 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Kazia Therapeutics Limited
 2001-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Phenoxodiol (Haginin E) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phenoxodiol functions as an isoflavone derivative that directly inhibits DNA topoisomerase II and downregulates FLICE inhibitory protein while suppressing X-linked inhibitor of apoptosis, thereby driving caspase pathway activation and programmed cell death in tumor cells. This pro-apoptotic and chemosensitizing activity provides the mechanistic basis for its clinical evaluation in recalcitrant malignancies, including prostate cancer, ovarian carcinoma, and soft-tissue sarcomas.

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.