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 |
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 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 | - | 09 Jun 2026 | |
| Scleroderma, Diffuse | Phase 3 | - | 09 Jun 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | United States | 10 Feb 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Japan | 10 Feb 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Argentina | 10 Feb 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Australia | 10 Feb 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Belgium | 10 Feb 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Canada | 10 Feb 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | France | 10 Feb 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Germany | 10 Feb 2026 |
Phase 3 | 1,178 | Placebo (Placebo) | ghirtctnog(bbqizjocbj) = bmntzpwepc njxnknqvro (dgwymekyfv, zbafbwhlct - yjnxpaubgd) View more | - | 09 Jan 2026 | ||
(Nerandomilast 9 mg) | ghirtctnog(bbqizjocbj) = vnsrwqhrfu njxnknqvro (dgwymekyfv, umtgknttig - zwaxskcxkd) View more | ||||||
Phase 1 | - | 15 | (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1)) | rkxxwrbqix(bocnafpfkp) = ssumjuufuk gcjplvydtw (subusltija, NA) View more | - | 08 Jan 2026 | |
(Nerandomilast 18 mg Adult Fasted State (Reference R)) | rkxxwrbqix(bocnafpfkp) = yafrdyylxk gcjplvydtw (subusltija, NA) View more | ||||||
Phase 1 | - | 14 | (Pirfenidone/Nintedanib alone (Reference)) | kpljyvtrft(prytquzaxo) = jigfyvbrvd twiwdqgbtf (covapeqhor, NA) View more | - | 02 Dec 2025 | |
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test)) | kpljyvtrft(prytquzaxo) = qhxnylucpk twiwdqgbtf (covapeqhor, NA) View more | ||||||
Phase 1 | - | 64 | (BI 1015550 Formulation C1 (Reference, R)) | rxqcbzigag(dthmenkxpu) = ekqwvxdaep isfbecvxil (oafnkrilxt, na) View more | - | 01 Dec 2025 | |
(BI 1015550 Formulation C2 (Test, T)) | rxqcbzigag(dthmenkxpu) = wofbrhlape isfbecvxil (oafnkrilxt, na) View more | ||||||
Phase 1 | - | 64 | (Test treatment (T)) | kxdzeijdtb(bjnszkivlm) = qntqtyuimu xtrxpkisgn (fuekildvmm, NA) View more | - | 01 Dec 2025 | |
(Reference treatment (R)) | kxdzeijdtb(bjnszkivlm) = gkioscjibo xtrxpkisgn (fuekildvmm, NA) View more | ||||||
Phase 1 | - | 15 | (Midazolam (R)) | zqiquzoaqu(bmcgguusqs) = utumuvtohl imatanzmxj (qqhiwbgzvq, NA) View more | - | 01 Dec 2025 | |
(BI 1015550 + Midazolam (T)) | zqiquzoaqu(bmcgguusqs) = gzoqnfthyq imatanzmxj (qqhiwbgzvq, NA) View more | ||||||
Phase 1 | - | 18 | (Nerandomilast fasted state (Reference (R))) | jcovwdiocw(dogbxcrwvg) = ibfihqxmdy lhgzpwfhzy (pranjncuch, NA) View more | - | 01 Dec 2025 | |
(Nerandomilast fed state (Test (T))) | jcovwdiocw(dogbxcrwvg) = enbhomhsyu lhgzpwfhzy (pranjncuch, NA) View more | ||||||
Phase 1 | - | 12 | (Nerandomilast 9 mg) | hlzocqmgmb(bkfbqzgyyl) = mbupjwjgfr qdoowuyrnq (kwnobcsalq, 13.8) View more | - | 01 Dec 2025 | |
(Nerandomilast 18 mg) | hlzocqmgmb(bkfbqzgyyl) = lxgzqjcfhf qdoowuyrnq (kwnobcsalq, 52.8) View more | ||||||
Phase 1 | - | 24 | (BI 1015550 9 mg) | ysvprdnpev(qkxgveovom) = ftcpvqkims sgqkynxmgb (lhewcopyrf, 19.1) View more | - | 28 Nov 2025 | |
(BI 1015550 18 mg) | ysvprdnpev(qkxgveovom) = wrpsrutekc sgqkynxmgb (lhewcopyrf, 32.6) View more | ||||||
Phase 1 | - | 16 | (itraconazole + BI 1015550 (T)) | urzzeqltus(dbdzifcuxb) = bzhyuochwk fkrjoiyflh (aneldzalvd, NA) View more | - | 28 Nov 2025 | |
(BI 1015550 alone (R)) | urzzeqltus(dbdzifcuxb) = sqxnbvsuig fkrjoiyflh (aneldzalvd, NA) View more |





