Penfluridol Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

A clinical trial is currently evaluating penfluridol for oncology indications in an early-phase, Phase 1/2 study sponsored by an academic medical center, Union Hospital at Tongji Medical College of Huazhong University of Science and Technology. Not yet recruiting, this trial focuses on patients with relapsed or refractory small cell carcinoma, specifically targeting small cell lung cancer and small cell cervical carcinoma. This effort underscores ongoing clinical investigation into repurposing the compound for refractory neuroendocrine tumors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07206563	NOT_YET_RECRUITING	Small Cell Carcinoma; Small Cell Carcinoma of Lung; Small Cell Lung Cancer ( SCLC ); Small Cell Cervical Carcinoma	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	2025-10-01	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-10-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Penfluridol acts as a potent antagonist of dopamine D2 receptors and T-type calcium channels, thereby suppressing downstream oncogenic signaling cascades including the Gli1 and Akt pathways. This targeted blockade disrupts cellular survival mechanisms to trigger apoptotic and autophagic cell death, ultimately inhibiting tumor growth in small cell carcinomas such as small cell lung cancer and small cell cervical carcinoma.

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>).