A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.

Start Date13 Nov 2024

Sponsor / Collaborator

AstraZeneca PLC

CTIS2024-513142-11-00 / Recruiting

- D9090C00007

Start Date27 Sep 2024

Sponsor / Collaborator

AstraZeneca AB

NCT06639087 / RecruitingPhase 1

Phase Ib Randomised, Placebo-controlled, Double-blind, Multicentre Study to Assess the Effects and Safety of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment

A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.

Start Date27 Sep 2024

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with AZD-5462

100 Translational Medicine associated with AZD-5462

100 Patents (Medical) associated with AZD-5462

Literatures (Medical) associated with AZD-5462

28 Mar 2024·Journal of Medicinal ChemistryQ1 · MEDICINE

Discovery of Clinical Candidate AZD5462, a Selective Oral Allosteric RXFP1 Agonist for Treatment of Heart Failure

Q1 · MEDICINE

Article

Author: Granberg, Kenneth L ; Kato, Harutoshi ; Kimura, Junpei ; Idei, Akiko ; Villar, Inmaculada C ; Persson, Mikael ; Gradén, Henrik ; Miyazaki, Shiki ; Niwa, Yasuki ; Backmark, Anna ; Bergonzini, Giulia ; Fujita, Takuya ; Sakamaki, Shigeki ; Yoneda, Hikaru ; Ulander, Johan ; Mochida, Hideki ; Ryberg, Erik ; Lal, Mark ; Iguchi, Kaori ; Sakamoto, Toshiaki ; Fjellström, Ola ; Arvidsson, Torbjörn ; Larsson, Niklas ; Prieto Garcia, Luna ; Fuchigami, Ryuichi ; Bergström, Fredrik ; Althage, Magnus

Optimization of the highly potent and selective, yet metabolically unstable and poorly soluble hRXFP1 agonist AZ7976 led to the identification of the clinical candidate, AZD5462. Assessment of RXFP1-dependent cell signaling demonstrated that AZD5462 activates a highly similar panel of downstream pathways as relaxin H2 but does not modulate relaxin H2-mediated cAMP second messenger responsiveness. The therapeutic potential of AZD5462 was assessed in a translatable cynomolgus monkey heart failure model. Following 8 weeks of treatment with AZD5462, robust improvements in functional cardiac parameters including LVEF were observed at weeks 9, 13, and 17 without changes in heart rate or mean arterial blood pressure. AZD5462 was well tolerated in both rat and cynomolgus monkey and has successfully completed phase I studies in healthy volunteers. In summary, AZD5462 is a small molecule pharmacological mimetic of relaxin H2 signaling at RXFP1 and holds promise as a potential therapeutic approach to treat heart failure patients.

100 Deals associated with AZD-5462

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic heart failure	Phase 2	HU	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	IN	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	CZ	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	JP	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	US	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	NL	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	PL	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	SK	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	DK	AstraZeneca PLC	04 Jun 2024
Chronic heart failure	Phase 2	BG	AstraZeneca PLC	04 Jun 2024

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