Clinical Trials

Cortisone is currently evaluated in several clinical trials spanning Phase 2, Phase 4, and unassigned phases across conditions including primary adrenal insufficiency, knee osteoarthritis, atopic dermatitis, obesity, Alzheimer's disease, polymyalgia rheumatica, and giant cell arteritis. Sponsored by various academic institutions and industry organizations, these studies range in status from actively recruiting to active, not recruiting. Research focuses include intra-articular therapies for knee osteoarthritis and hydrocortisone formulations for hormone replacement in adrenal insufficiency.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cortisone functions as a glucocorticoid prodrug that, upon metabolic activation to cortisol, binds intracellular glucocorticoid receptors to inhibit pro-inflammatory transcription factor signaling and suppress cytokine production. This cellular immunosuppression leads to reduced leukocyte recruitment and decreased vascular permeability, mediating clinical anti-inflammatory and replacement effects in disorders such as osteoarthritis, atopic dermatitis, and adrenal insufficiency.

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>).

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