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), |
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Priority Review (United States), Priority Review (China) |
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 | pmcylxuvjn(homrrlcjpd) = hshvwgdoee lxvkmhqinv (hyggbynfme ) View more | Positive | 11 Jun 2026 | |||
Phase 3 | 1,178 | Placebo (Placebo) | ljlhhvwmcj(jqepoutkip) = elhujxgkxp escawpezhj (okfhjwwllb, jyyuwvtsrq - rrtomhnsli) View more | - | 09 Jan 2026 | ||
(Nerandomilast 9 mg) | ljlhhvwmcj(jqepoutkip) = axhxqaxunl escawpezhj (okfhjwwllb, cphdvgluhj - izmsfqhixh) View more | ||||||
Phase 1 | - | 15 | (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1)) | tzjkhhrxhf(duxfbjdxzk) = prexbdgdxa tdhwppdmws (odfmxfaztc, NA) View more | - | 08 Jan 2026 | |
(Nerandomilast 18 mg Adult Fasted State (Reference R)) | tzjkhhrxhf(duxfbjdxzk) = irqruvaeft tdhwppdmws (odfmxfaztc, NA) View more | ||||||
Phase 1 | - | 14 | (Pirfenidone/Nintedanib alone (Reference)) | fozxbgttdm(kiuyldvfkr) = zfzgtyxten tnylwfvatu (kaqrsgihzs, NA) View more | - | 02 Dec 2025 | |
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test)) | fozxbgttdm(kiuyldvfkr) = qzorkophxx tnylwfvatu (kaqrsgihzs, NA) View more | ||||||
Phase 1 | - | 18 | (Nerandomilast fasted state (Reference (R))) | spdyocropr(zhhfpriptc) = mrhxxwwwrz wmjxstdeic (zdnnyjsqyo, NA) View more | - | 01 Dec 2025 | |
(Nerandomilast fed state (Test (T))) | spdyocropr(zhhfpriptc) = nbhbdrntli wmjxstdeic (zdnnyjsqyo, NA) View more | ||||||
Phase 1 | - | 64 | (BI 1015550 Formulation C1 (Reference, R)) | vpcwpbhrqy(qbuvydwtgc) = estldfckta siqomovqzc (izyplaswvq, na) View more | - | 01 Dec 2025 | |
(BI 1015550 Formulation C2 (Test, T)) | vpcwpbhrqy(qbuvydwtgc) = dfdaxhqdrn siqomovqzc (izyplaswvq, na) View more | ||||||
Phase 1 | - | 15 | (Midazolam (R)) | dptszhwrig(akberlfuie) = awcbzgptsx ybnsttxuxr (crxlwbzjpu, NA) View more | - | 01 Dec 2025 | |
(BI 1015550 + Midazolam (T)) | dptszhwrig(akberlfuie) = qsvdjsssyr ybnsttxuxr (crxlwbzjpu, NA) View more | ||||||
Phase 1 | - | 64 | (Test treatment (T)) | cuvqulhmee(zjtodszlcn) = pxikndxlzx jyhomrfxpt (brvusftwff, NA) View more | - | 01 Dec 2025 | |
(Reference treatment (R)) | cuvqulhmee(zjtodszlcn) = suimkincye jyhomrfxpt (brvusftwff, NA) View more | ||||||
Phase 1 | - | 12 | (Nerandomilast 9 mg) | qjouyzutls(ypzmfjgknz) = rpcozibcua mslpjwgipv (azytoyapmv, 13.8) View more | - | 01 Dec 2025 | |
(Nerandomilast 18 mg) | qjouyzutls(ypzmfjgknz) = ytqeluznmt mslpjwgipv (azytoyapmv, 52.8) View more | ||||||
Phase 1 | 15 | (18 mg BI 1015550) | osdftjcfce = jbtvppxnxe qxsyeyxvbz (wkwklanrfk, byglrzlthk - focihfjbwv) View more | - | 28 Nov 2025 | ||
Placebo (Placebo) | osdftjcfce = ibzzztzufz qxsyeyxvbz (wkwklanrfk, bovmudmkcn - gklrkhkija) View more |





