Boehringer completes enrollment in nerandomilast-pirfenidone interaction study
The Phase 2 pharmacokinetic study, now closed to enrollment, will test whether pirfenidone changes blood levels of nerandomilast, the PDE4B inhibitor Boehringer sells as JASCAYD for IPF.
Executive Summary
- A Boehringer Ingelheim pharmacokinetic study testing whether pirfenidone changes blood levels of its PDE4B inhibitor nerandomilast has finished enrolling and moved to active follow-up ahead of its primary completion date.
- The trial measures drug-drug interaction, not efficacy: whether combining two approved idiopathic pulmonary fibrosis therapies changes how much of either drug reaches the bloodstream.
- Nerandomilast is already approved and being layered into a wider IPF and interstitial lung disease development program, so this readout will shape how the two mechanisms can be prescribed together in practice.
- The primary completion date moved repeatedly over the trial's life before settling into its current window, but enrollment itself closed on target and without incident.
The study
NCT06241560 enrolls adults with idiopathic pulmonary fibrosis who take a single dose of nerandomilast, then pirfenidone at escalating doses over three weeks, then a second nerandomilast dose, so investigators can compare drug levels in the blood before and after co-administration. The trial's primary endpoints are pharmacokinetic: the area under the concentration-time curve and the maximum measured concentration of nerandomilast in plasma, measured through study day 34. This is a drug-interaction study, not an efficacy trial, and its 20-patient target reflects that narrower purpose. NCT06241560A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the BloodNCT06241560
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The status change
The trial moved from Recruiting to Active, not recruiting on July 14, 2026, after enrollment reached its full target of 20 patients, exactly matching the number originally planned. Boehringer's operational risk model flags enrollment shifts of 20% or more; this trial closed at its target with no change, a routine transition rather than an operational signal. Enrollment began March 5, 2026, and completed within about four months, in line with the target-indication benchmark of 336 median enrollment days for PDE4B trials in idiopathic pulmonary fibrosis. NCT06241560+1A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the BloodNCT06241560A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the BloodJul 14, 2026
Timeline history
The trial's primary completion date has moved seven times since 2025, sliding from an original August 1, 2025 target to the current August 4, 2026 date, a shift of just over a year across those revisions. The date has settled since January 26, 2026, and the most recent registry update confirms the trial remains on track for that same August 4 window, now backed by a completed enrollment cohort. NCT06241560A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the BloodNCT06241560
Why it matters for the drug
Nerandomilast won FDA approval as JASCAYD, an oral tablet for idiopathic pulmonary fibrosis, and Boehringer is running it across five active or completed trials spanning Phase 1 through Phase 3, including a long-term follow-up study and a Phase 3 program in broader interstitial lung disease. Pirfenidone, the older approved antifibrotic for the same disease, is not itself in Boehringer's development portfolio; testing the interaction addresses a practical prescribing question rather than a competitive one, since physicians may need to combine or switch between approved IPF therapies. No other industry trial pairs a PDE4B inhibitor with pirfenidone in this indication, making this the only interaction study of its kind on record for the combination. NCT06241560A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the BloodNCT06241560
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.