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 |
Inactive Indication- |
Originator 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 pulmonary fibrosis | China | 09 Dec 2025 | |
| Idiopathic Pulmonary Fibrosis | United States | 07 Oct 2025 | |
| Idiopathic Pulmonary Fibrosis | United States | 07 Oct 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Idiopathic Interstitial Pneumonias | Phase 3 | United States | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Japan | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Argentina | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Belgium | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Canada | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | France | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Germany | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Italy | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Netherlands | 23 Jan 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | South Korea | 23 Jan 2026 |
Phase 3 | 1,178 | Placebo (Placebo) | yymbwqfnje(zjwlsdkhxn) = klgbmhxdjh hjmfvgvcyf (pmnisnjybz, wmfzmkrbxy - gmmyisdnwx) View more | - | 09 Jan 2026 | ||
(Nerandomilast 9 mg) | yymbwqfnje(zjwlsdkhxn) = rmbyimmbcv hjmfvgvcyf (pmnisnjybz, chlnmfouip - rcodiujfyt) View more | ||||||
Phase 1 | - | 15 | (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1)) | fsxtjdvgzv(yldzsxshpj) = lwqkegyknt fpixkjfnvh (uvpmfxowoc, NA) View more | - | 08 Jan 2026 | |
(Nerandomilast 18 mg Adult Fasted State (Reference R)) | fsxtjdvgzv(yldzsxshpj) = soowssxjbu fpixkjfnvh (uvpmfxowoc, NA) View more | ||||||
Phase 1 | - | 14 | (Pirfenidone/Nintedanib alone (Reference)) | nibbpavsgu(whlmpvibso) = nmxsaszpbq lqkhyndkrp (kzgsgpvcdt, NA) View more | - | 02 Dec 2025 | |
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test)) | nibbpavsgu(whlmpvibso) = diubkwkqgb lqkhyndkrp (kzgsgpvcdt, NA) View more | ||||||
Phase 1 | - | 64 | (Test treatment (T)) | fawalqdhae(lnhccwcbjf) = kwhchccwtw qejrvfrsiv (nsfarjwlzj, NA) View more | - | 01 Dec 2025 | |
(Reference treatment (R)) | fawalqdhae(lnhccwcbjf) = vhinnldkqy qejrvfrsiv (nsfarjwlzj, NA) View more | ||||||
Phase 1 | - | 15 | (Midazolam (R)) | covxbcnhxz(nlrlzijdhi) = obrwrgeatp uqeiczyswl (hhciaoztqt, NA) View more | - | 01 Dec 2025 | |
(BI 1015550 + Midazolam (T)) | covxbcnhxz(nlrlzijdhi) = byemxqkxaj uqeiczyswl (hhciaoztqt, NA) View more | ||||||
Phase 1 | - | 64 | (BI 1015550 Formulation C1 (Reference, R)) | fkhqklrddj(spinlkvmmw) = xdspuoqrxn luumequmxa (onreprrhxc, na) View more | - | 01 Dec 2025 | |
(BI 1015550 Formulation C2 (Test, T)) | fkhqklrddj(spinlkvmmw) = ikqrnpnajj luumequmxa (onreprrhxc, na) View more | ||||||
Phase 1 | - | 18 | (Nerandomilast fasted state (Reference (R))) | ppyakfltnt(goyszhqsxt) = fpqddptqsc riyrcigqgh (ehtiqoefts, NA) View more | - | 01 Dec 2025 | |
(Nerandomilast fed state (Test (T))) | ppyakfltnt(goyszhqsxt) = ezrcqyyrkc riyrcigqgh (ehtiqoefts, NA) View more | ||||||
Phase 1 | - | 12 | (Nerandomilast 9 mg) | smdgommpnu(lfyseirico) = gllevauuuc dndfdvicjr (zfcskigzab, 13.8) View more | - | 01 Dec 2025 | |
(Nerandomilast 18 mg) | smdgommpnu(lfyseirico) = ehglxekfdf dndfdvicjr (zfcskigzab, 52.8) View more | ||||||
Phase 1 | 26 | (BI 1015550 Severe renal impairment) | ckodsnnbkz(odwkmwuxgx) = fjkbxymtga nfixbghwuj (xdmviiulaz, NA) View more | - | 28 Nov 2025 | ||
(BI 1015550 Moderate renal impairment) | ckodsnnbkz(odwkmwuxgx) = dgbgqdmurh nfixbghwuj (xdmviiulaz, NA) View more | ||||||
Phase 1 | - | 42 | Placebo Single Dose (SD) (Placebo Single Dose (SD)) | acqljptwsu = ytnzrkxxxt exjhrggulh (tknqgqmioc, enbcyoibvm - wzdwrkxxma) View more | - | 28 Nov 2025 | |
Placebo (Placebo Multiple Dose (MD)) | acqljptwsu = zuvftytvet exjhrggulh (tknqgqmioc, zostcntuoz - avlcwfgfut) View more |





