Trilostane Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Several Phase II clinical trials have evaluated trilostane for steroid-dependent oncology and reproductive health conditions. Industry-sponsored research by Genzyme (a Sanofi company) examined the compound in completed studies for prostate cancer and prostate adenocarcinoma. Additionally, investigator-led research sponsored by Kristina Gemzell Danielsson evaluated combination therapy for medical abortion and early pregnancy termination, though this trial was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01615211	TERMINATED	Medical Abortion, Complete or Unspecified, Without Complication	Kristina Gemzell Danielsson	2012-05	PHASE2
NCT00181597	COMPLETED	Prostate Cancer; Prostate Adenocarcinoma	Genzyme, a Sanofi Company	2004-03	PHASE2
NCT00181597	Completed	Prostate Cancer\|Prostate Adenocarcinoma	Genzyme a Sanofi Company\|Sanofi	2004-03	Phase 2

(data from https://clinicaltrials.gov, updated on 2015-05-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trilostane acts as a selective inhibitor of 3β-hydroxysteroid dehydrogenase, blocking the essential enzymatic conversion of precursor steroids into cortisol, aldosterone, and androgenic steroids. This targeted suppression of steroidogenesis reduces hormone-mediated cellular signaling, which directly accounts for its clinical investigation in hormone-dependent malignancies such as prostate cancer as well as the management of hypercortisolism.

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>).