Drugs / Nerandomilast
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Jascayd | — | 2026-07-15 | europa.eu ↗ |
| Approved | US (FDA) | JASCAYD | — | 2025-10-07 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 123 trials | ||||||
| Phase 1 | NCT07081932 | Aug → Sep 2025 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT07100964 | Aug → Sep 2025 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06624072 | Oct → Nov 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06408870 | Jun → Aug 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06393127 | Jun → Sep 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06415045 | May → Jul 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06107036 | Mar → Jul 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06139302 | Dec 2023 → Feb 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06070610 | Nov → Dec 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05707403 | Feb → Mar 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05718648 | Feb → Aug 2023 | impaired renal function disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05661344 | Feb → Sep 2023 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05633862 | Jan → Mar 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05550636 | Oct → Dec 2022 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05428436 | Aug → Sep 2022 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT04771286 | Mar → May 2021 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03542344 | Jun → Aug 2018 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03403439 | May → Jul 2018 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03422068 | Mar 2018 → Jul 2019 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03302078 | Oct → Dec 2017 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03230487 | Aug 2017 → Jan 2018 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01835899 | Apr → Jun 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01594515 | May → Sep 2012 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT06241560 | Mar → Aug 2026 overdue | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06195072 | Apr 2024 → Nov 2026 expected | interstitial lung disease, scleroderma | Scleroderma Research Foundation, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04419506 | Jul 2020 → Oct 2021 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | Met primary |
| Phase 39 trials · 2 met primary | ||||||
| Phase 3 | NCT07789015 | Nov 2026 → Mar 2030 expected | idiopathic inflammatory myopathy | Boehringer Ingelheim | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07540988 | Sep 2026 → Dec 2028 expected | interstitial lung disease | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 3 | NCT07497087 | Jul 2026 → Feb 2030 expected | systemic sclerosis | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 3 | NCT07366034 | Jul 2026 → Apr 2029 expected | pulmonary fibrosis | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 3 | NCT07201922 | Feb 2026 → May 2029 expected | pulmonary fibrosis | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 3 | NCT06806592 | Sep 2025 → Jul 2027 expected | interstitial lung disease | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06238622 | May 2024 → Apr 2027 expected | idiopathic pulmonary fibrosis, pulmonary fibrosis | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05321082 | Nov 2022 → Dec 2024 | interstitial lung disease | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT05321069 | Oct 2022 → Aug 2024 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07570888 | Jun 2026 → Jun 2027 expected | pulmonary fibrosis | University of British Columbia | Not yet recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2/3 | NCT07321860 Comparator | Jun 2026 → Jun 2027 expected | amyotrophic lateral sclerosis | Gipfel Life Sciences GmbH | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07299695 Comparator | Jan 2026 → Jun 2028 expected | idiopathic pulmonary fibrosis | Argyrios Tzouvelekis | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-12-22 | Boehringer Ingelheim | Regulatory U.S. FDA approves JASCAYD® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults prnewswire.com ↗
Boehringer Ingelheim's JASCAYD ® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults. |
| 2022-05-15 | Boehringer Ingelheim | Results Boehringer Ingelheim's latest investigational treatment slowed lung function decline in people living with idiopathic pulmonary fibrosis prnewswire.com ↗
Today, Boehringer Ingelheim announced Phase II data for BI 1015550, a novel investigational phosphodiesterase 4B (PDE4B) inhibitor, that was published in The New England Journal of Medicine (NEJM). |
| 2022-02-24 | Boehringer Ingelheim | Regulatory FDA Grants BI 1015550 Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis prnewswire.com ↗
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to its novel investigational therapy, BI 1015550, for the treatment of idiopathic pulmonary fibrosis (IPF). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-22 | Boehringer Ingelheim | U.S. FDA approves JASCAYD® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults prnewswire.com ↗ |
| 2022-10-26 | Boehringer Ingelheim | Boehringer Ingelheim enrolls first patient in Phase III trial of BI 1015550 in idiopathic pulmonary fibrosis prnewswire.com ↗ |
| 2022-05-15 | Boehringer Ingelheim | Boehringer Ingelheim's latest investigational treatment slowed lung function decline in people living with idiopathic pulmonary fibrosis prnewswire.com ↗ |
| 2022-02-24 | Boehringer Ingelheim | FDA Grants BI 1015550 Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis prnewswire.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nerandomilast | “Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.” NCT06195072 ↗16“Antifibrotics (nintedanib, pirfenidone, or nerandomilast) will be continued during hospitalization if already prescribed and not contraindicated.” NCT07299695 ↗ “Nerandomilast (BI 1015550), an oral preferential inhibitor of phosphodiesterase 4B, is being evaluated in two randomized Phase III trials” PMID 41345848 ↗ Dec 2025 |
| Known as | BI1015550 | “Nerandomilast (BI 1015550), an oral preferential inhibitor of phosphodiesterase 4B, is being evaluated in two randomized Phase III trials” PMID 41345848 ↗ Dec 202523“three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally” NCT05428436 ↗ “Drug: BI1015550” NCT01835899 ↗ |
| Action | Inhibit | “inhibitor of the PDE4B subtype” PMID 35569036 ↗ May 2022 |
| Modality | Small molecule | — CHEMBL5314532 ↗ |
| Route | Oral | “Single Rising Oral Doses” NCT01594515 ↗ |
| Target | PDE4B | “inhibitor of the PDE4B subtype” PMID 35569036 ↗ May 2022 |