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 35 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07540988 | Aug 2026 → Dec 2028 expected | interstitial lung disease | Boehringer Ingelheim | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07366034 | Jul 2026 → Apr 2029 expected | pulmonary fibrosis | Boehringer Ingelheim | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07497087 | Jul 2026 → Feb 2030 expected | systemic sclerosis | Boehringer Ingelheim | Not yet 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 | autoimmune interstitial lung disease-arthritis syndrome, interstitial lung disease | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 3 | NCT06238622 | May 2024 → Apr 2027 expected | idiopathic pulmonary fibrosis, pulmonary fibrosis | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 3 | NCT05321082 | Nov 2022 → Dec 2024 | interstitial lung disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT05321069 | Oct 2022 → Aug 2024 | idiopathic pulmonary fibrosis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07570888 | Jun 2026 → Jun 2027 expected | pulmonary fibrosis | University of British Columbia | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07321860 Comparator | Jun 2026 → Jun 2027 expected | amyotrophic lateral sclerosis | Gipfel Life Sciences GmbH | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07299695 Comparator | Jan 2026 → Jun 2028 expected | idiopathic pulmonary fibrosis | Argyrios Tzouvelekis | Recruiting | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 39 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 ↗15“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 | BI 1015550 | “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 |