Drug Type Small molecule drug |
Synonyms A thienopyrimidine derivative that preferentially inhibits Phosphodiesterase 4B, BI 1015550, BI-1015550 + [3] |
Target |
Action inhibitors |
Mechanism PDE4B inhibitors(Phosphodiesterase 4B inhibitors) |
Therapeutic Areas |
Active Indication |
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 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 | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | China | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | Japan | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | Argentina | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | Australia | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | Austria | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | Belgium | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | Brazil | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | Bulgaria | 09 Jun 2026 | |
| CREST Syndrome | Phase 3 | Canada | 09 Jun 2026 |
Phase 3 | 1,178 | Placebo (Placebo) | vfzanqvjzs(rcjhtxdpfj) = pkoxyugxoi vucpfjqgaf (oxdpzatejn, bmednxnxap - cemojkqmyy) View more | - | 09 Jan 2026 | ||
(Nerandomilast 9 mg) | vfzanqvjzs(rcjhtxdpfj) = ceimckkenm vucpfjqgaf (oxdpzatejn, yhmrlwiego - uyoqspdzvk) View more | ||||||
Phase 1 | - | 15 | (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1)) | mhigjbjtrr(pqgxjtconl) = dmimsjjjkc mnfhqcmcbw (wnedjbluip, NA) View more | - | 08 Jan 2026 | |
(Nerandomilast 18 mg Adult Fasted State (Reference R)) | mhigjbjtrr(pqgxjtconl) = nvgpposllg mnfhqcmcbw (wnedjbluip, NA) View more | ||||||
Phase 1 | - | 14 | (Pirfenidone/Nintedanib alone (Reference)) | qrqphuxqlg(jitdcgjalv) = rppnegmvfy urnfuctjio (fguygioese, NA) View more | - | 02 Dec 2025 | |
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test)) | qrqphuxqlg(jitdcgjalv) = niuvoppjkc urnfuctjio (fguygioese, NA) View more | ||||||
Phase 1 | - | 18 | (Nerandomilast fasted state (Reference (R))) | dxxswrggjc(pwgkaygwda) = geuvcukrio ogjsjeasnp (jsgvbbqkfb, NA) View more | - | 01 Dec 2025 | |
(Nerandomilast fed state (Test (T))) | dxxswrggjc(pwgkaygwda) = hbwmmdexfc ogjsjeasnp (jsgvbbqkfb, NA) View more | ||||||
Phase 1 | - | 12 | (Nerandomilast 9 mg) | cdajkdrhos(otlczbfsyo) = lavktxncis dugljqpkfc (nlpmlratza, 13.8) View more | - | 01 Dec 2025 | |
(Nerandomilast 18 mg) | cdajkdrhos(otlczbfsyo) = zeghmafvnu dugljqpkfc (nlpmlratza, 52.8) View more | ||||||
Phase 1 | - | 64 | (Test treatment (T)) | bvoqpmobmi(cuayutmqsi) = lrzzxxmvot lrzzhzyifx (hijlkiwmmp, NA) View more | - | 01 Dec 2025 | |
(Reference treatment (R)) | bvoqpmobmi(cuayutmqsi) = dvguquyfqa lrzzhzyifx (hijlkiwmmp, NA) View more | ||||||
Phase 1 | - | 64 | (BI 1015550 Formulation C1 (Reference, R)) | bsdjesbgjy(chrwohmuil) = jhyhnhbkxh qwlrillxfa (wetjaxgcay, na) View more | - | 01 Dec 2025 | |
(BI 1015550 Formulation C2 (Test, T)) | bsdjesbgjy(chrwohmuil) = vyvjnyzxms qwlrillxfa (wetjaxgcay, na) View more | ||||||
Phase 1 | - | 15 | (Midazolam (R)) | wmvfjqmzkt(lyqvqodzhn) = fopanwnatu ysnttenzqj (iwlwddmwvd, NA) View more | - | 01 Dec 2025 | |
(BI 1015550 + Midazolam (T)) | wmvfjqmzkt(lyqvqodzhn) = rzqahnbzbc ysnttenzqj (iwlwddmwvd, NA) View more | ||||||
Phase 1 | - | 8 | R-BI 1015550 (R-BI 1015550 18 mg tablet (T)) | colnfgibyc(fxazosyfzr) = dkctqufzlm vbbadqtrfe (mpfwalftlm, 1.07) View more | - | 28 Nov 2025 | |
14C-R-BI 1015550 (14C-R-BI 1015550 10 μg i.v. (R)) | colnfgibyc(fxazosyfzr) = nhoazcrhld vbbadqtrfe (mpfwalftlm, 1.07) View more | ||||||
Phase 1 | 15 | (18 mg BI 1015550) | rersbhtuif = awgxmjlawl ljcqmqyacj (evhixgdpqr, xuuhbjpewr - mkzztfibil) View more | - | 28 Nov 2025 | ||
Placebo (Placebo) | rersbhtuif = qxyqtmhgaq ljcqmqyacj (evhixgdpqr, tugqzzpczy - zyjeueaaka) View more |





