Deoxycorticosterone acetate Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Several industry-sponsored clinical trials have investigated conditions such as Cushing's syndrome, Cushing's disease, and castration-resistant prostate cancer. Sponsored by Recordati Group, Novartis Pharmaceuticals, and Janssen Pharmaceutical K.K., these completed studies encompassed Phase 1, Phase 2, and unassigned observational classifications. Specific evaluations included a retrospective observational study on Cushing's syndrome, a Phase 2 proof-of-concept trial in Cushing's disease, and a Phase 1 safety and tolerability study in patients with prostate cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05633953	Completed	Cushing''s Syndrome	RECORDATI GROUP	2023-01-16	--
NCT01331239	Completed	Cushings Disease\|Cushing Disease	Novartis Pharmaceuticals\|Novartis	2011-03-23	Phase 2
NCT01186484	Completed	Prostatic Neoplasms	Janssen Pharmaceutical K.K.	2010-06-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Deoxycorticosterone acetate functions as a precursor steroid hormone and mineralocorticoid receptor agonist, promoting renal sodium reabsorption and water retention while altering systemic electrolyte balances. This mineralocorticoid-driven modulation of mineral homeostasis and endocrine feedback pathways is clinically relevant for evaluating adrenocortical hormone function and managing endocrine conditions such as Cushing's syndrome and 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>).