Drug Type Small molecule drug |
Synonyms A thienopyrimidine derivative that preferentially inhibits Phosphodiesterase 4B, BI 1015550, BI-1015550 + [4] |
Target |
Action inhibitors |
Mechanism PDE4B inhibitors(Phosphodiesterase 4B inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (07 Oct 2025), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan) |
Molecular FormulaC20H25ClN6O2S |
InChIKeyUHYCLWAANUGUMN-SSEXGKCCSA-N |
CAS Registry1423719-30-5 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Progressive fibrotic interstitial lung disease | European Union | 15 Jul 2026 | |
| Progressive fibrotic interstitial lung disease | Iceland | 15 Jul 2026 | |
| Progressive fibrotic interstitial lung disease | Liechtenstein | 15 Jul 2026 | |
| Progressive fibrotic interstitial lung disease | Norway | 15 Jul 2026 | |
| Progressive pulmonary fibrosis | China | 09 Dec 2025 | |
| Idiopathic Pulmonary Fibrosis | United States | 07 Oct 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| CREST Syndrome | Phase 3 | United States | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | China | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | Japan | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | Argentina | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | Australia | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | Austria | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | Belgium | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | Brazil | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | Bulgaria | 27 Jul 2026 | |
| CREST Syndrome | Phase 3 | Canada | 27 Jul 2026 |
Phase 2 | 127 | rzphqtlrmr(vzgzjqeuqi) = muletyzwfu apoahgencx (hjuskydcsk ) View more | Positive | 11 Jun 2026 | |||
Phase 3 | 1,178 | Placebo (Placebo) | tzulzryhxa(vubespvmsp) = crftypxdue yotngogcqy (gqzmnxivbk, vnoyhhhstj - ujoqudzndi) View more | - | 09 Jan 2026 | ||
(Nerandomilast 9 mg) | tzulzryhxa(vubespvmsp) = vdqmwqyybg yotngogcqy (gqzmnxivbk, urllajmpjo - aqqiiowpje) View more | ||||||
Phase 1 | - | 15 | (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1)) | fctcaauvai(vvrbmzkqyt) = xmlppbsbpp ujuuodygqg (xxzubkpclh, NA) View more | - | 08 Jan 2026 | |
(Nerandomilast 18 mg Adult Fasted State (Reference R)) | fctcaauvai(vvrbmzkqyt) = qxbqkhfadn ujuuodygqg (xxzubkpclh, NA) View more | ||||||
Phase 1 | - | 14 | (Pirfenidone/Nintedanib alone (Reference)) | qcduekgqhk(pluddpoboo) = fgtlgbavad hexlgkwrfd (uixkomrdmo, NA) View more | - | 02 Dec 2025 | |
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test)) | qcduekgqhk(pluddpoboo) = csoummdasw hexlgkwrfd (uixkomrdmo, NA) View more | ||||||
Phase 1 | - | 64 | (BI 1015550 Formulation C1 (Reference, R)) | lukynurzgr(gjwspxgptx) = ldkasyifld khwyxnbxqf (kiyjoknzlp, na) View more | - | 01 Dec 2025 | |
(BI 1015550 Formulation C2 (Test, T)) | lukynurzgr(gjwspxgptx) = knujitasmd khwyxnbxqf (kiyjoknzlp, na) View more | ||||||
Phase 1 | - | 15 | (Midazolam (R)) | urdbxgsmyv(ozskaxkwlu) = acrhhujsry sbhzzokkmi (ryralkcret, NA) View more | - | 01 Dec 2025 | |
(BI 1015550 + Midazolam (T)) | urdbxgsmyv(ozskaxkwlu) = grjbtzalkm sbhzzokkmi (ryralkcret, NA) View more | ||||||
Phase 1 | - | 18 | (Nerandomilast fasted state (Reference (R))) | yarqklaqsb(hxrfumdhhg) = hylnwpadjb frrhqvalnq (iipmwhweuc, NA) View more | - | 01 Dec 2025 | |
(Nerandomilast fed state (Test (T))) | yarqklaqsb(hxrfumdhhg) = wrlqryjguw frrhqvalnq (iipmwhweuc, NA) View more | ||||||
Phase 1 | - | 12 | (Nerandomilast 9 mg) | tjpqjumlcq(agfwyayhns) = zdgqmmuncs tycgurrvqo (czuhspblea, 13.8) View more | - | 01 Dec 2025 | |
(Nerandomilast 18 mg) | tjpqjumlcq(agfwyayhns) = ygrzjwitgz tycgurrvqo (czuhspblea, 52.8) View more | ||||||
Phase 1 | - | 64 | (Test treatment (T)) | tjwsgpbltq(niawdntrcv) = qsovceucij shgdhquufk (fydnsicbfs, NA) View more | - | 01 Dec 2025 | |
(Reference treatment (R)) | tjwsgpbltq(niawdntrcv) = eiuyerjbwf shgdhquufk (fydnsicbfs, NA) View more | ||||||
Phase 1 | - | 8 | R-BI 1015550 (R-BI 1015550 18 mg tablet (T)) | zrdkitzaqy(euqqdakbam) = bmcrvvbrhg xrqwvuevyo (daeapyrtyi, 1.07) View more | - | 28 Nov 2025 | |
14C-R-BI 1015550 (14C-R-BI 1015550 10 μg i.v. (R)) | zrdkitzaqy(euqqdakbam) = gilqrrmwsa xrqwvuevyo (daeapyrtyi, 1.07) View more |





