Clinical Trials

Multiple clinical trials spanning Phase 2 through Phase 4 evaluate hydrocortisone hemisuccinate in critical care, focusing on septic shock, sepsis, acute respiratory failure, and renal transplant immunosuppression. Predominantly sponsored by European medical centers, these studies range from early terminated research to completed dosing trials. Active recruiting initiatives continue to investigate immunosuppressive management strategies in critically ill renal transplant patients presenting with severe sepsis or respiratory failure.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06881927 RECRUITING
Sepsis and Septic Shock; Acute Respiratory Failure; Kidney Transplant Recipients; Immunosuppressive Agents
University Hospital, Strasbourg, France
 2026-08-11 PHASE4
NCT01817153 TERMINATED
Septic Shock; Adult
Centre Hospitalier Régional d'Orléans
 2013-11-05 PHASE2; PHASE3
NCT02768740 COMPLETED
Septic Shock
Association Niçoise de Réanimation Médicale
 2008-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydrocortisone hemisuccinate functions as a physiological glucocorticoid that inhibits proinflammatory cytokine release, specifically targeting Interleukin-6 (IL-6, IC50 = 6.7 μM) and IL-3 (IC50 = 21.4 μM) to disrupt downstream inflammatory signaling cascades. This cellular suppression of immune mediator release attenuates hyperinflammatory cascades and vascular dysfunction, underlying its clinical application in managing adult septic shock, acute respiratory failure, and severe post-transplant inflammatory complications.

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.