Galeterone Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 470

Clinical Trials

Galeterone has been evaluated across multiple clinical trials led by industry sponsors such as LTN Pharmaceuticals Inc. and academic institutions including the University of Maryland, Baltimore, spanning Phase 1 through Phase 3 stages. Investigating safety, pharmacokinetics, and therapeutic efficacy, these studies include a completed Phase 1 mass balance trial in healthy males, terminated Phase 2 and Phase 3 trials in prostate cancer, and an active Phase 2 trial evaluating galeterone combined with gemcitabine for metastatic pancreatic adenocarcinoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04098081	ACTIVE_NOT_RECRUITING	Advanced Pancreatic Cancer	University of Maryland, Baltimore	2019-12-12	PHASE2
NCT01709734	TERMINATED	Prostate Cancer	LTN PHARMACEUTICALS, INC.	2012-12	PHASE2
NCT02438007	TERMINATED	Prostate Cancer	LTN PHARMACEUTICALS, INC.	2015-06	PHASE3
NCT02729376	COMPLETED	Healthy	LTN PHARMACEUTICALS, INC.	2016-03	PHASE1
NCT02729376	Completed	Healthy	LTN PHARMACEUTICALS INC.	2016-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Galeterone directly inhibits CYP17 and competitively binds to the androgen receptor while promoting receptor degradation, which suppresses androgen-mediated transcriptional signaling and triggers endoplasmic reticulum stress response in tumor cells. This disruption of androgen pathways and cellular homeostasis impairs cell survival and drives tumor growth inhibition, providing therapeutic rationale for its evaluation in clinical trials for prostate cancer and advanced pancreatic 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>).