Several clinical trials evaluate or monitor corticosterone across diverse indications, including prostate cancer, acne vulgaris, autistic disorder, coxarthrosis, and physiological assessments of newborn genitalia. Sponsored by academic centers and industrial partners, these studies encompass observational protocols alongside interventional trials ranging from Phase 1 to Phase 3. Across this landscape, recruitment statuses vary from completed and actively recruiting to unknown.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05903716 | Recruiting | Acne Vulgaris |
Marmara University |
2022-09-15 | -- |
| NCT04930471 | Unknown status | Autistic Disorder |
Insel Gruppe AG University Hospital Bern|Lindenhofstiftung |
2021-06 | -- |
| NCT02826278 | Unknown status | Newborn Genitalia |
Hospices Civils de Lyon |
2014-10 | -- |
| NCT01666314 | Completed | Prostate Cancer |
Millennium Pharmaceuticals Inc.|Takeda |
2012-08-20 | Phase 1|Phase 2 |
| NCT01079455 | UNKNOWN | Coxarthrosis |
University Hospital Pellenberg |
2010-05 | PHASE3 |
| 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
Corticosterone
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.