Clinical Trials

Several clinical trials evaluate cortisone acetate and related glucocorticoid formulations across conditions including primary adrenal insufficiency, polymyalgia rheumatica, giant cell arteritis, knee osteoarthritis, obesity, atopic dermatitis, and dementia. Spanning Phase 2, Phase 4, and non-interventional designs, these studies are sponsored by academic research institutions, university hospital networks, and private healthcare entities. Maintaining active recruitment statuses—including currently recruiting and active, not recruiting—these trials evaluate therapeutic efficacy and systemic hormone regulation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04855630 Recruiting
Alzheimer Disease|Dementia
University of Miami|Shipley Foundation|Dreem
2023-03-01 Not Applicable
NCT05790083 Active not recruiting
Atopic Dermatitis|Eczema-Prone Skin
Bionorica SE
2023-01-03 Not Applicable
NCT05336968 Recruiting
Osteoarthritis Knee
United Health Services Hospitals Inc.
2022-09-15 Phase 4
NCT05435781 Recruiting
Adrenal Insufficiency|Polymyalgia Rheumatica|Giant Cell Arteritis
Ulla Feldt-Rasmussen|Aarhus University Hospital|Odense University Hospital|Rigshospitalet Denmark
2022-06-07 Phase 4
NCT05237440 Recruiting
Obesity
University Hospital Limoges
2022-04-13 Not Applicable
NCT05222152 Active not recruiting
Primary Adrenal Insufficiency
Diurnal Limited
2021-11-23 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a glucocorticoid steroid, cortisone acetate binds to intracellular glucocorticoid receptors and translocates to the nucleus, where it suppresses pro-inflammatory gene transcription and downregulates inflammatory cytokine signaling. This biochemical inhibition suppresses immune mediator release and reduces tissue inflammation, providing therapeutic efficacy in managing conditions such as primary adrenal insufficiency and osteoarthritis.

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>).

Note: Technical data last updated: Sep 1, 2026.