Clinical Trials

Multiple clinical trials are evaluating targeted therapeutic strategies for advanced prostate malignancies, including metastatic prostate cancer, non-metastatic castration-resistant prostate cancer, and metastatic hormone-sensitive prostate cancer. Sponsored by Sorrento Therapeutics Inc. and Bayer, these Phase 2 and unassigned-phase studies demonstrate varying recruitment statuses, currently reported as suspended or not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05361915 Suspended
Prostate Cancer|Prostate Cancer Metastatic
Sorrento Therapeutics Inc.
 2025-09 Phase 2
NCT06334120 Not yet recruiting
Non-metastatic Castration-resistant Prostate Cancer|Metastatic Hormone-sensitive Prostate Cancer
Bayer
 2024-09-01 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Petroselinic acid, a positional isomer of oleic acid, integrates into cellular lipid bilayers and modulates membrane-associated lipid signaling networks, thereby disrupting downstream biochemical cascades essential for cellular proliferation. This impairment of lipid-dependent survival pathways suppresses cancer cell proliferation, providing biological rationale for its investigation in advanced and metastatic prostate 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.