BI 1819479 / Boehringer Ingelheim - LARVOL DELTA

A Study to Test How BI 1819479 is Taken up and Processed by the Body (clinicaltrials.gov) - P1 | N=7 | Terminated | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2026 ➔ Oct 2025 | N=14 ➔ 7 | Trial completion date: Jun 2026 ➔ Nov 2025; Company decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

A Study to Test How BI 1819479 is Taken up and Processed by the Body (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Test How BI 1819479 is Taken up and Processed by the Body (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study to Test How BI 1819479 is Taken up and Processed by the Body (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

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

A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jul 2026 ➔ Feb 2026 | Trial primary completion date: May 2026 ➔ Dec 2025

Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

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

Boehringer's Idiopathic Pulmonary Fibrosis New Drug Candidate Receives Domestic Phase 2 Approval [Google translation] (News1 Korea) - "According to the Ministry of Food and Drug Safety on the 5th, Boehringer Ingelheim received approval for the domestic phase 2 clinical trial plan for the idiopathic pulmonary fibrosis new drug candidate 'BI 1819479' on the 3rd. This clinical trial is part of the global phase 2 clinical trial....The domestic clinical trial of BI 1819479 will be conducted at eight hospitals: Seoul Asan Medical Center, Severance Hospital, Bundang Seoul National University Hospital, Bucheon St. Mary's Hospital, Kyung Hee University Hospital, Soonchunhyang University Seoul Hospital, Haeundae Paik Hospital, and Sanggye Paik Hospital. The total number of patients recruited from around the world is 300."

Trial status • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease

A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Boehringer Ingelheim

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

U.S. FDA Grants BI 1819479 Orphan Drug Designation for Idiopathic Pulmonary Fibrosis (Boehringer Ingelheim Press Release) - "Behringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BI 1819479 for the potential treatment of idiopathic pulmonary fibrosis (IPF)....The FDA granted Orphan Drug Designation to BI 1819479 based on the availability of preclinical data. A phase II clinical trial is scheduled to begin in 2024."

New P2 trial • Orphan drug • Idiopathic Pulmonary Fibrosis

A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479 (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Boehringer Ingelheim | Recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Dec 2022 | Trial primary completion date: Apr 2023 ➔ Dec 2022

Trial completion • Trial completion date • Trial primary completion date

A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479 (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479 (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479 (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food (clinicaltrials.gov) - P1 | N=66 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed