Nerandomilast History and Updates

48 events · 2023 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

2
FDA Approvals
0
Label Revisions
46
Trial Milestones
0
Pivotal Publications
Nerandomilast — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2024202520262027202820292030Trial: NCT07540988 2026-08-28 → 2028-12-05 (primary completion)Trial: NCT07366034 2026-07-27 → 2029-04-27 (primary completion)Trial: NCT07321860 2026-06-30 → 2027-06-30 (primary completion)Trial: NCT07570888 2026-06-30 → 2027-06-30 (primary completion)Trial: NCT07497087 2026-06-22 → 2030-02-26 (primary completion)Trial: NCT07201922 2026-02-10 → 2029-05-14 (primary completion)Trial: NCT06806592 2025-09-13 → 2027-07-17 (primary completion)Trial: NCT07081932 2025-08-26 → 2025-09-27 (primary completion)Trial: NCT07100964 2025-08-11 → 2025-09-20 (primary completion)Trial: NCT06624072 2024-10-15 → 2024-11-22 (primary completion)Trial: NCT06393127 2024-06-04 → 2024-09-10 (primary completion)Trial: NCT06238622 2024-05-06 → 2027-04-28 (primary completion)Trial: NCT06195072 2024-04-15 → 2026-11-30 (primary completion)Trial: NCT06139302 2023-12-20 → 2024-02-07 (primary completion)FDA approval — 2025-10-07 FDA approved Jascayd (nerandomilast) (NDA 218764) Sponsor: BOEHRINGER INGELHEIM. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2026-02-26 FDA approved supplemental application for Jascayd (nerandomilast) — Labeling (NDA 218764 S-1) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.Results posted — 2025-12-01 Trial results posted: NCT06393127 A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the BodyResults posted — 2025-12-01 Trial results posted: NCT06139302 A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese MenResults posted — 2026-01-08 Trial results posted: NCT06624072 A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Foodtoday (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Nerandomilast since 2023, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (4)

2026
2025

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 2/Phase 3 trial started: NCT07321860
This Study Evaluates the Safety, Target Engagement, and Preliminary Efficacy of Galunisertib (TGF-βR1/ALK5 Inhibitor)Combined With Nerandomi
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT07570888
This is a Trial Designed to Evaluate the Combination of Nerandomilast With Mycophenolate Across a Wide Variety of Pulmonary Fibrosis Subtype
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07366034
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Dis
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07540988
FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06238622
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Ne
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT07570888
This is a Trial Designed to Evaluate the Combination of Nerandomilast With Mycophenolate Across a Wide Variety of Pulmonary Fibrosis Subtype
Primary completion· ClinicalTrials.gov
Phase 2/Phase 3 primary completion: NCT07321860
This Study Evaluates the Safety, Target Engagement, and Preliminary Efficacy of Galunisertib (TGF-βR1/ALK5 Inhibitor)Combined With Nerandomi
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07540988
FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07366034
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Dis
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07201922
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

Past events

2026
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07201922
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
Results posted· ClinicalTrials.gov
Trial results posted: NCT06624072
A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food
2025
Results posted· ClinicalTrials.gov
Trial results posted: NCT06393127
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
Results posted· ClinicalTrials.gov
Trial results posted: NCT06139302
A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06806592
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07081932
A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07100964
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood
2024
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06624072
A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06624072
A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06393127
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06393127
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06238622
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Ne
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06139302
A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men
2023
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06139302
A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.