Clinical Trials

Multiple AstraZeneca-sponsored Phase I and Phase II clinical trials evaluate the safety, pharmacokinetics, and therapeutic efficacy of AZD-5462 in healthy volunteers and patients with heart failure or renal impairment. Completed research encompasses a Phase IIb trial in stable chronic heart failure along with Phase I pharmacokinetic and tolerability studies in healthy and renally impaired populations. Although several clinical trials are complete, a Phase Ib trial examining AZD-5462 in combination with dapagliflozin was prematurely terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06299826 COMPLETED
Chronic Heart Failure
AstraZeneca
 2024-06-04 PHASE2
NCT06989983 COMPLETED
Heart Failure
AstraZeneca
 2025-05-20 PHASE1
NCT06639087 TERMINATED
Renal Impairment; Heart Failure
AstraZeneca
 2024-09-27 PHASE1
NCT06661733 COMPLETED
Renal Impairment
AstraZeneca
 2024-11-18 PHASE1
NCT05512806 COMPLETED
Healthy Participants
AstraZeneca
 2022-08-24 PHASE1
NCT04994106 COMPLETED
Healthy Participants
AstraZeneca
 2021-07-27 PHASE1
NCT05395117 COMPLETED
Healthy Participants
AstraZeneca
 2022-06-30 PHASE1

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

Check the AZD-5462 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD-5462 selectively modulates relaxin family peptide receptor 1 (RXFP1), a GPCR family 1c member, thereby regulating downstream intracellular signaling cascades to exert robust anti-fibrotic and anti-inflammatory cellular effects. By suppressing pathological tissue remodeling and inflammatory responses, this targeted modulation provides therapeutic utility in clinical conditions such as chronic heart failure and renal impairment.

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.