Clinical Trials

Multiple clinical trials have evaluated conditions associated with this research compound, encompassing Phase 2 platform evaluations of early post-exposure protocols for COVID-19 and observational studies on sleep apnea in type 1 diabetes mellitus. Supported by institutional sponsors, including the Henry M. Jackson Foundation for the Advancement of Military Medicine and the Centre Hospitalier Universitaire, Amiens, these trials have successfully completed recruitment.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05954286 COMPLETED
SARS-CoV-2
Henry M. Jackson Foundation for the Advancement of Military Medicine
 2024-01-29 PHASE2
NCT03506022 COMPLETED
Diabetes Mellitus, Type 1
Centre Hospitalier Universitaire, Amiens
 2018-01-12

(data from https://clinicaltrials.gov, updated on 2026-04-17)

Check the Apostatin-1 (Apt-1) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Apostatin-1 selectively binds to the N-terminal TRAF2-binding domain of TRADD (TRADD-N), preventing essential adapter assemblies required for downstream signaling and inhibiting both bortezomib-induced apoptosis and RIPK1-dependent apoptosis with an IC50 of approximately 1 μM. By mitigating TRADD-mediated apoptotic cascades and pro-inflammatory signaling networks, this molecular inhibition offers potential therapeutic relevance in limiting systemic inflammation and cell injury observed in clinical conditions such as SARS-CoV-2 infection and type 1 diabetes mellitus.

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.