Clinical Trials

The clinical evaluation of Apelin-13 is represented across several clinical trials focusing primarily on cardiorespiratory, renal, and endocrine disorders. Academic and institutional sponsors, including Imperial College London, the University Hospital Basel, and the University of Edinburgh, have spearheaded early-phase investigations to assess the compound's physiological potential. These studies, which include completed Phase 1 and early-stage mechanistic evaluations such as NCT01590108 and NCT03956576, target conditions including idiopathic pulmonary arterial hypertension, chronic kidney disease, cardiovascular disease, and endothelial dysfunction. Additionally, clinical research protocols like NCT06277336 have explored the physiological impact of apelin administration in syndrome of inappropriate antidiuresis and hyponatremia. Together, these completed investigations highlight an ongoing effort to translate APJ receptor modulation into clinical strategies for managing vascular and fluid balance pathology.

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 Apelin-13 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Apelin-13 functions as an endogenous peptide agonist that potently binds to the APJ receptor with nanomolar affinity, thereby regulating intracellular signaling pathways including adenylate cyclase activity and downstream cyclic AMP production. By activating APJ receptor-mediated signaling, Apelin-13 promotes vasodilation and improves vascular homeostasis, providing a mechanistic foundation for its clinical investigation in pulmonary arterial hypertension, cardiovascular disease, and renal endothelial dysfunction.

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.