Humanin Clinical Trials

Size	Price	Qty
5mg	USD 270
25mg	USD 810

Clinical Trials

Multiple clinical trials evaluate the clinical relevance of Humanin in renal and cardiovascular conditions, such as acute kidney injury, end-stage kidney disease, renal transplantation, myocardial ischemia, and complications following coronary artery bypass surgery. Sponsored by academic and clinical institutions, including the University of Gaziantep, the University of Tartu, and Guangdong Provincial People's Hospital, these studies investigate circulating or tissue Humanin levels to assess cellular stress responses and postoperative outcomes. Featuring recruiting, completed, and unknown recruitment statuses, these trials currently have unspecified phases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07678073	RECRUITING	Kidney Disease, End-Stage; Kidney Transplant; Kidney; Kidney Disease; Renal Transplant	University of Gaziantep	2026-03-01

(data from https://clinicaltrials.gov, updated on 2026-07-08)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Humanin, a mitochondrial-derived cytoprotective peptide, interacts with cell-surface receptor complexes and pro-apoptotic BCL-2 family proteins, triggering JAK/STAT signaling pathways to prevent mitochondrial outer membrane permeabilization and suppress cellular apoptosis. This cytoprotective suppression of oxidative stress and cell death provides a biological rationale for evaluating Humanin expression and function in clinical settings involving ischemic tissue damage and renal dysfunction, such as acute kidney injury, myocardial ischemia, and renal transplantation.

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>).