Cyperotundone Clinical Trials

Size	Price	Qty
1mg	USD 159

Clinical Trials

Multiple Phase II clinical trials have evaluated this therapeutic candidate for treating conditions such as COVID-19 complicated by lymphocytopenia and refractory nontuberculous mycobacterial lung infections. Sponsored by Revimmune alongside academic and clinical collaborators—including Washington University School of Medicine, Memorial Sloan Kettering Cancer Center, M.D. Anderson Cancer Center, and Amarex Clinical Research—all of these studies have been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04927169	Terminated	COVID-19\|Lymphocytopenia	Revimmune\|C.R.O. ReSolution Latin America S.A.	2021-03-01	Phase 2
NCT04426201	Terminated	COVID-19\|Lymphocytopenia	Revimmune\|Memorial Sloan Kettering Cancer Center\|Amarex Clinical Research\|M.D. Anderson Cancer Center\|Cancer Research Institute New York City	2020-12-20	Phase 2
NCT04154826	Terminated	Mycobacterium Infections Nontuberculous	Revimmune\|Washington University School of Medicine	2020-11-30	Phase 2
NCT04442178	Terminated	COVID-19\|Lymphocytopenia	Revimmune\|Washington University School of Medicine\|Amarex Clinical Research	2020-09-15	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cyperotundone binds to specific cellular regulatory targets to inhibit downstream inflammatory signaling cascades, consequently suppressing pro-inflammatory cytokine expression and preventing cellular damage. This attenuation of hyperinflammatory signaling helps restore host immune homeostasis, offering clinical relevance for addressing immune dysfunction in conditions such as COVID-19 with lymphocytopenia and nontuberculous mycobacterial infections.

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>).