AZD2389 / AstraZeneca - LARVOL DELTA

PECHORA: The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis. (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

PECHORA: The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis. (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=12 ➔ 7

Enrollment change • Enrollment closed • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

Imaging of Fibroblast Activation Protein: AZD2389 demonstrates liver target occupancy in participants with advanced chronic liver disease (EASL 2026) - "Radioligand [68Ga]Ga-FAPI-46 demonstrated suitable kinetics and test-retest reliability for assessment of hepatic FAP. Single-dose AZD2389 produced measurable hepatic FAP occupancy at trough, confirming target engagement and supporting dose selection for early clinical development."

Metastases • Fibrosis • Hepatology • Immunology

Pharmacodynamics, pharmacokinetics, safety, and tolerability of AZD2389, a fibroblast activation protein inhibitor in participants with liver fibrosis and compensated cirrhosis (EASL 2026) - P2 | "AZD2389 was safe and well tolerated in participants with steatotic liver disease and fibrosis. AZD2389 showed a favourable PK profile consistent with once‑daily dosing, without plasma accumulation during repeated dosing. AZD2389 achieved robust FAP inhibition throughout the dosing period of 28 days, accompanied by a reduction in physiological in vivo FAP substrate alpha‑2‑antiplasmin."

Clinical • PK/PD data • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis • FGF21

Imaging of Fibroblast Activation Protein: AZD2389 demonstrates liver target occupancy in participants with advanced chronic liver disease (EASL 2026) - No abstract available

Metastases • Hepatology

BRAVO: Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis (clinicaltrials.gov) - P2 | N=104 | Recruiting | Sponsor: AstraZeneca

New P2 trial • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • PRO-C3

D7930C00003: A Phase 1 open-label positron emission tomography TRIAL to assess changes in liver uptake of [68Ga]Ga-FAPI-46 following oral administration of single doses of AZD2389 to patients with advanced liver fibrosis (PECHORA) (clinicaltrialsregister.eu) - P1 | N=12 | Active, not recruiting | Sponsor: AstraZeneca AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Immunology • Liver Cirrhosis

CAMPOLINA: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion • Hepatology

A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

PECHORA: The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis. (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: AstraZeneca

New P1 trial • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

BORANA: A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis. (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Hepatology

BORANA: A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis. (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=24 ➔ 16

Enrollment change • Enrollment closed • Hepatology

CRIOLLO: A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=16 ➔ 8

Enrollment change • Enrollment closed • Hepatology

CAMPOLINA: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Dec 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Hepatology

A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Hepatology

CRIOLLO: A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Hepatology

CRIOLLO: A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion

First-in-human single and multiple ascending dose study of AZD2389, a potent inhibitor of fibroblast activation protein, in healthy participants to evaluate safety, tolerability, pharmacokinetics and target engagement (EASL 2025) - "In healthy participants, there were no safety or tolerability concerns up to the highest dose of AZD2389 tested in both the SAD and MAD parts. AZD2389 is a selective FAP inhibitor and is being studied further as a treatment for liver fibrosis."

Clinical • P1 data • PK/PD data • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • FGF21

A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: AstraZeneca | N=24 ➔ 16

Enrollment change

A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open