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Nerandomilast

Alternative Names: Nerandomilast, bi-1015550, bi1015550, bi 1015550
Clinical Status: Active
Latest Update: 2025-06-25
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Nerandomilast

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

FIBRONEER™-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