(Ala13)-Apelin-13 Clinical Trials

Size	Price	Qty
5mg	USD 159

Clinical Trials

The therapeutic potential of targeting the apelin-APJ signaling axis has been evaluated across several clinical trials focusing on vascular, metabolic, and renal pathologies. Early-phase clinical research, including completed studies sponsored by Imperial College London, University Hospital Basel, and the University of Edinburgh, has explored the systemic effects of apelin receptor modulation. Specific trials such as NCT01590108, NCT06277336, and NCT03956576 have completed recruitment to evaluate acute cardiopulmonary and physiological responses in human subjects. These completed Phase 1 investigations primarily target conditions including idiopathic pulmonary arterial hypertension, syndrome of inappropriate antidiuresis, hyponatremia, chronic kidney disease, cardiovascular diseases, and endothelial dysfunction.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06277336	COMPLETED	SIAD - Syndrome of Inappropriate Antidiuresis; Hyponatremia	University Hospital, Basel, Switzerland	2024-03-01
NCT03956576	COMPLETED	Chronic Kidney Diseases; Cardiovascular Diseases; Endothelial Dysfunction	University of Edinburgh	2020-02-04
NCT01590108	COMPLETED	Idiopathic Pulmonary Arterial Hypertension	Imperial College London	2012-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-03-30)

Check the (Ala13)-Apelin-13 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(Ala13)-Apelin-13 functions as a potent antagonist of the APJ receptor, competitively binding the active site to block downstream G-protein-coupled signal transduction and apelin-mediated smooth muscle relaxation. By inhibiting receptor activation and restoring cellular tone, this compound provides a valuable tool for investigating APJ signaling in the context of cardiovascular diseases, endothelial dysfunction, and pulmonary arterial hypertension.

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>).