AZD8965 / AstraZeneca - LARVOL DELTA

AZD8965, a novel oral arginase inhibitor, shows consistent safety, tolerability and pharmacokinetic profile in healthy Chinese and Japanese participants: results from a Phase 1 study (ERS 2026) - P1 | "Conclusions In healthy Japanese and Chinese participants, oral dosing of AZD8965 for up to 8 days was well tolerated. The safety and PK profiles of AZD8965 in Japanese and Chinese participants were comparable to those observed in healthy participants in the global study, supporting similar dosing of AZD8965 across multiple ethnicities."

Clinical • P1 data • PK/PD data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

AZD8965: Data from P2b ARGiNAUT trial (NCT07652658) for IPF post 2027 (AstraZeneca) - H1 & Q2 2026 Results

P2b data • Idiopathic Pulmonary Fibrosis

ARGiNAUT: A Phase IIb Study to Evaluate AZD8965 in Participants With IPF. (clinicaltrials.gov) - P2 | N=359 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

ARGiNAUT: A Phase IIb Study to Evaluate AZD8965 in Participants With IPF. (clinicaltrials.gov) - P2 | N=359 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Randomized Phase 1 Study in Healthy Volunteers Investigating the Safety, Tolerability, Pharmacokinetics, and Target Engagement of AZD8965, a Novel Oral Arginase Inhibitor Under Development as a Treatment for Pulmonary Fibrosis (ATS 2026) - No abstract available

Clinical • P1 data • PK/PD data • Immunology • Pulmonary Disease • Respiratory Diseases

A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD8965 in Healthy Participants (Including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants (clinicaltrials.gov) - P1 | N=147 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed | Trial primary completion date: Nov 2025 ➔ Jun 2025

Trial completion • Trial primary completion date

Arginase inhibitor AZD8965: A novel therapeutic approach for idiopathic pulmonary fibrosis (ERS 2025) - "Moreover, in two Bleomycin-induced in- vivo mouse models of IPF, we successfully demonstrated the efficacy of AZD8965 to reduce lung ornithine levels (≥66%) and collagen synthesis (≥47%), resulting in an improvement in lung fibrosis endpoints. These findings support our hypothesis that reducing ornithine levels can effectively limit the availability of essential collagen building blocks. Consequently, our arginase inhibitor, AZD8965, emerges as a promising candidate for future monotherapy or combination therapies aimed at enhancing efficacy and tolerability in IPF treatment, with potential applicability extending beyond lung fibrosis."

Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ARG1

A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD8965 in Healthy Participants (Including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants (clinicaltrials.gov) - P1 | N=163 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open