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)
Mechanism and Biochemical Profile
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>).