Clinical Trials

Multiple Phase 1, Phase 2, and Phase 3 clinical trials are evaluating nerandomilast (BI 1015550) for respiratory and fibrotic conditions—including idiopathic pulmonary fibrosis, progressive pulmonary fibrosis, systemic disease-related interstitial lung disease, and scleroderma—alongside safety assessments in healthy individuals and those with hepatic or renal impairment. Sponsored by Boehringer Ingelheim in collaboration with organizations such as the Scleroderma Research Foundation, Inc., these pharmacokinetic and extension studies span various recruitment stages, including active recruitment, completed protocols, and trials not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06238622 RECRUITING
Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis
Boehringer Ingelheim
 2024-05-06 PHASE3
NCT06195072 RECRUITING
Interstitial Lung Disease Due to Systemic Disease; Scleroderma
Scleroderma Research Foundation, Inc.
 2024-04-15 PHASE2
NCT06241560 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2026-03-05 PHASE2
NCT05321082 COMPLETED
Lung Diseases, Interstitial
Boehringer Ingelheim
 2022-11-16 PHASE3
NCT06393127 COMPLETED
Healthy
Boehringer Ingelheim
 2024-06-04 PHASE1
NCT06408870 COMPLETED
Healthy
Boehringer Ingelheim
 2024-06-06 PHASE1
NCT05321069 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2022-10-06 PHASE3
NCT06241560 Not yet recruiting
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2024-08-06 Phase 2
NCT06107036 COMPLETED
Healthy
Boehringer Ingelheim
 2024-03-06 PHASE1
NCT06415045 COMPLETED
Healthy
Boehringer Ingelheim
 2024-05-28 PHASE1
NCT06107036 Recruiting
Healthy
Boehringer Ingelheim
 2024-03-04 Phase 1
NCT06139302 COMPLETED
Healthy
Boehringer Ingelheim
 2023-12-20 PHASE1
NCT06070610 COMPLETED
Healthy
Boehringer Ingelheim
 2023-11-08 PHASE1
NCT05661344 COMPLETED
Hepatic Insufficiency
Boehringer Ingelheim
 2023-02-07 PHASE1
NCT05718648 COMPLETED
Renal Insufficiency; Healthy
Boehringer Ingelheim
 2023-02-09 PHASE1
NCT05707403 COMPLETED
Healthy
Boehringer Ingelheim
 2023-02-14 PHASE1
NCT05633862 COMPLETED
Healthy
Boehringer Ingelheim
 2023-01-13 PHASE1
NCT05718648 Completed
Renal Insufficiency|Healthy
Boehringer Ingelheim
 2023-02-09 Phase 1
NCT05550636 COMPLETED
Healthy
Boehringer Ingelheim
 2022-10-11 PHASE1
NCT05428436 COMPLETED
Healthy
Boehringer Ingelheim
 2022-08-15 PHASE1
NCT04419506 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2020-07-28 PHASE2
NCT04771286 COMPLETED
Healthy
Boehringer Ingelheim
 2021-03-25 PHASE1
NCT04771286 Completed
Healthy
Boehringer Ingelheim
 2021-03-25 Phase 1
NCT03422068 COMPLETED
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2018-03-16 PHASE1
NCT03542344 COMPLETED
Healthy
Boehringer Ingelheim
 2018-06-04 PHASE1
NCT03403439 COMPLETED
Healthy
Boehringer Ingelheim
 2018-05-03 PHASE1
NCT03422068 Completed
Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim
 2018-03-16 Phase 1
NCT03230487 COMPLETED
Healthy
Boehringer Ingelheim
 2017-08-10 PHASE1
NCT03302078 COMPLETED
Healthy
Boehringer Ingelheim
 2017-10-16 PHASE1
NCT01835899 COMPLETED
Healthy
Boehringer Ingelheim
 2013-04 PHASE1
NCT01594515 COMPLETED
Healthy
Boehringer Ingelheim
 2012-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-20)

Check the Nerandomilast (BI 1015550) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nerandomilast (BI 1015550) selectively binds to and inhibits phosphodiesterase 4B (PDE4B) with an IC50 of 7.2 nM, preventing the hydrolysis of cyclic adenosine monophosphate (cAMP) and elevating intracellular cAMP levels within immune and structural pulmonary cells. This accumulation of intracellular cAMP suppresses the release of pro-inflammatory cytokines and attenuates downstream fibrotic signaling, thereby mitigating tissue remodeling and progressive lung function decline in clinical trial conditions such as idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.