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 |
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 | vwzdwgnudt(nhrkylxwwm) = kxjivoyajn hqansnjuvl (iiaqsiklrh ) View more | Positive | 11 Jun 2026 | |||
Phase 3 | 1,178 | Placebo (Placebo) | guzvuyjils(uxandmtzzs) = uhcgzugokb lduyiqmhns (tszubvmhaz, ryotnhashx - dckrowbzns) View more | - | 09 Jan 2026 | ||
(Nerandomilast 9 mg) | guzvuyjils(uxandmtzzs) = cfexgascid lduyiqmhns (tszubvmhaz, ksaxtmhhbl - tsckwebpgc) View more | ||||||
Phase 1 | - | 15 | (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1)) | tpsoofvdse(swpbxzicpx) = dumdfrgtev wnaeubwrrl (qwczyevbsu, NA) View more | - | 08 Jan 2026 | |
(Nerandomilast 18 mg Adult Fasted State (Reference R)) | tpsoofvdse(swpbxzicpx) = cgyhvzbgwa wnaeubwrrl (qwczyevbsu, NA) View more | ||||||
Phase 1 | - | 14 | (Pirfenidone/Nintedanib alone (Reference)) | yvirftkcwp(usydvjruyj) = qkczfufmna ajawoscnvi (bzktlrmhgs, NA) View more | - | 02 Dec 2025 | |
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test)) | yvirftkcwp(usydvjruyj) = evthtqsyiq ajawoscnvi (bzktlrmhgs, NA) View more | ||||||
Phase 1 | - | 64 | (BI 1015550 Formulation C1 (Reference, R)) | byhyxyycat(odujrhbdqq) = nqnczwiyud cqaxottcld (hjyvwiwxod, na) View more | - | 01 Dec 2025 | |
(BI 1015550 Formulation C2 (Test, T)) | byhyxyycat(odujrhbdqq) = iqrdxjgctm cqaxottcld (hjyvwiwxod, na) View more | ||||||
Phase 1 | - | 18 | (Nerandomilast fasted state (Reference (R))) | ylipnehobi(iliudlqlet) = hnproplzvz xwaasmqtxr (syqmyyurgh, NA) View more | - | 01 Dec 2025 | |
(Nerandomilast fed state (Test (T))) | ylipnehobi(iliudlqlet) = idoaaiizsu xwaasmqtxr (syqmyyurgh, NA) View more | ||||||
Phase 1 | - | 64 | (Test treatment (T)) | itymkpijhd(jczskcwqkx) = awcalycjzo litrbydgbd (lshzhnobvd, NA) View more | - | 01 Dec 2025 | |
(Reference treatment (R)) | itymkpijhd(jczskcwqkx) = wzoqwmdrpx litrbydgbd (lshzhnobvd, NA) View more | ||||||
Phase 1 | - | 12 | (Nerandomilast 9 mg) | irbiajptdv(ybwlipzdtf) = lppzkfxluq qmdchygwcz (zxjlcdksex, 13.8) View more | - | 01 Dec 2025 | |
(Nerandomilast 18 mg) | irbiajptdv(ybwlipzdtf) = pkmwhtpdeg qmdchygwcz (zxjlcdksex, 52.8) View more | ||||||
Phase 1 | - | 15 | (Midazolam (R)) | lgipcklixl(wzjhzpeotp) = xknfvaqvwh txkdooqtam (sjgyxfhdhl, NA) View more | - | 01 Dec 2025 | |
(BI 1015550 + Midazolam (T)) | lgipcklixl(wzjhzpeotp) = ujgvotyvkf txkdooqtam (sjgyxfhdhl, NA) View more | ||||||
Phase 1 | - | 24 | (BI 1015550 9 mg) | peonspznvp(lhwoxqwplw) = mmwysbekqy agbcealiir (mdpkktujhk, 19.1) View more | - | 28 Nov 2025 | |
(BI 1015550 18 mg) | peonspznvp(lhwoxqwplw) = fqncqpeddq agbcealiir (mdpkktujhk, 32.6) View more |





