Product Description
Anti-fibrotic
Mechanisms of Action: PDE4b Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Idiopathic Pulmonary Fibrosis|Pulmonary Fibrosis *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Boehringer Ingelheim
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 29
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Collagen Diseases|Idiopathic Pulmonary Fibrosis|Lung Diseases, Interstitial|Progressive Pulmonary Fibrosis
Phase 2: Scleroderma, Diffuse|Scleroderma, General|Scleroderma, Localized|Scleroderma, Systemic
Phase 1: Healthy Volunteers|Hepatic Insufficiency|Kidney Diseases|Liver Failure
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
---|---|---|---|---|---|---|---|
PDE4 Phase III trial in PF-ILD (Fibroneer-ILD) | P3 |
Completed |
Lung Diseases, Interstitial |
2025-04-14 |
69% |
2025-07-08 |
Treatments |
jRCT2021240008 | P3 |
Not yet recruiting |
Progressive Pulmonary Fibrosis |
2027-06-30 |
|||
1305-0031 | P3 |
Recruiting |
Idiopathic Pulmonary Fibrosis|Progressive Pulmonary Fibrosis |
2027-06-16 |
31% |
2025-05-02 |
Treatments |
FIBRONEERâ¢-ON | P3 |
Recruiting |
Progressive Pulmonary Fibrosis|Idiopathic Pulmonary Fibrosis |
2027-04-28 |
31% |
2024-07-25 |
Primary Endpoints|Start Date|Treatments|Trial Status |
1305-0046 | P3 |
Not yet recruiting |
Lung Diseases, Interstitial |
2027-03-31 |
23% |
2025-05-02 |
Treatments |
SARD-ILD | P3 |
Not yet recruiting |
Collagen Diseases|Lung Diseases, Interstitial |
2027-03-17 |
23% |
2025-02-07 |
Primary Endpoints|Treatments |
jRCT2031240052 | P2 |
Not yet recruiting |
Lung Diseases, Interstitial|Scleroderma, General |
2026-11-30 |
|||
CONQUEST | P2 |
Recruiting |
Lung Diseases, Interstitial|Scleroderma, Systemic|Scleroderma, Diffuse|Scleroderma, General|Scleroderma, Localized |
2026-11-01 |
12% |
2025-05-29 |
Primary Endpoints|Start Date|Treatments |
NCT06241560 | P2 |
Not yet recruiting |
Idiopathic Pulmonary Fibrosis |
2026-01-26 |
12% |
2025-06-26 |
Primary Endpoints |
FIBRONEER-IPF | P3 |
Completed |
Idiopathic Pulmonary Fibrosis |
2025-05-19 |
54% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
1305-0023 | P3 |
Active, not recruiting |
Lung Diseases, Interstitial |
2025-03-19 |
2025-05-02 |
Treatments |
|
jRCT2031220317 | P3 |
Recruiting |
Idiopathic Pulmonary Fibrosis |
2024-12-31 |
|||
PF-ILDs | P3 |
Completed |
Lung Diseases, Interstitial |
2024-12-18 |
69% |
2025-04-12 |
Primary Endpoints|Study Completion Date|Trial Status |
jRCT2031220475 | P3 |
Recruiting |
Lung Diseases, Interstitial |
2024-11-30 |
|||
1305-0029 | P1 |
Completed |
Healthy Volunteers |
2024-11-30 |
50% |
2025-05-02 |
Treatments |
U1111-1304-2287 | P1 |
Completed |
Healthy Volunteers |
2024-11-22 |
50% |
2024-12-19 |
Primary Endpoints |
U1111-1301-0834 | P1 |
Completed |
Healthy Volunteers |
2024-09-13 |
50% |
2024-10-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
U1111-1301-0913 | P1 |
Completed |
Healthy Volunteers |
2024-08-28 |
50% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05321069 | P3 |
Completed |
Idiopathic Pulmonary Fibrosis |
2024-08-16 |
54% |
2025-01-11 |
Primary Endpoints|Start Date|Study Completion Date|Trial Status |
NCT06107036 | P1 |
Completed |
Healthy Volunteers |
2024-07-25 |
50% |
2024-11-27 |
Primary Endpoints|Treatments |
U1111-1301-0891 | P1 |
Completed |
Healthy Volunteers |
2024-07-24 |
50% |
2024-07-27 |
|
jRCT2071230092 | P1 |
Recruiting |
Healthy Volunteers |
2024-04-30 |
|||
NCT06139302 | P1 |
Completed |
Healthy Volunteers |
2024-02-07 |
50% |
2024-03-20 |
Primary Endpoints |
U1111-1292-0376 | P1 |
Completed |
Healthy Volunteers |
2023-12-14 |
12% |
2023-12-29 |
Primary Endpoints|Treatments|Trial Status |
NCT05661344 | P1 |
Completed |
Liver Failure|Hepatic Insufficiency |
2023-09-13 |
23% |
2024-08-10 |
Patient Enrollment|Primary Endpoints|Treatments |