Cortodoxone (11-deoxycortisol) is being evaluated across several clinical trials investigating its metabolic, endocrine, and dermatologic roles in conditions such as Cushing's syndrome, acne vulgaris, cirrhosis with adrenal insufficiency, and healthy volunteers. Spanning Phase 1, Phase 2, and observational protocols, these studies assess systemic and topical effects as well as steroid hormone dynamics, with statuses including completed, recruiting, and active, not recruiting. Research sponsors encompass both academic centers and pharmaceutical companies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05633953 | Completed | Cushing''s Syndrome |
RECORDATI GROUP |
2023-01-16 | -- |
| NCT05903716 | Recruiting | Acne Vulgaris |
Marmara University |
2022-09-15 | -- |
| NCT04642391 | Active not recruiting | Cirrhosis|Adrenal Insufficiency |
University of Virginia|American Association for the Study of Liver Diseases |
2021-08-02 | -- |
| NCT03665194 | Completed | Healthy Volunteers |
Cassiopea SpA |
2018-06-06 | Phase 1 |
| NCT01831960 | Completed | Acne Vulgaris |
Intrepid Therapeutics Inc. |
2013-04 | 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>).