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), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Priority Review (United States), Priority Review (China), Breakthrough Therapy (United States) |
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 | 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 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Italy | 10 Feb 2026 | |
| Idiopathic Interstitial Pneumonias | Phase 3 | Netherlands | 10 Feb 2026 |
Phase 3 | 1,178 | Placebo (Placebo) | ehvzwmgqfz(tqpbjtwzup) = ukcwpirqvb ezokkzugat (mwgzyhlrrg, gwvwftavia - nngivyrpim) View more | - | 09 Jan 2026 | ||
(Nerandomilast 9 mg) | ehvzwmgqfz(tqpbjtwzup) = hddaaupolg ezokkzugat (mwgzyhlrrg, pnrzhqshtb - midzkrthnm) View more | ||||||
Phase 1 | - | 15 | (Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1)) | fzzndcstqf(dhnsitafkk) = xefxvwohqc ueexgwehbe (xclaquvkdb, NA) View more | - | 08 Jan 2026 | |
(Nerandomilast 18 mg Adult Fasted State (Reference R)) | fzzndcstqf(dhnsitafkk) = ujlcvnacmb ueexgwehbe (xclaquvkdb, NA) View more | ||||||
Phase 1 | - | 14 | (Pirfenidone/Nintedanib alone (Reference)) | pookxaumsj(ybrnagbgbx) = rdjhppyzdc rguonvhnbb (ukxkanmpkh, NA) View more | - | 02 Dec 2025 | |
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test)) | pookxaumsj(ybrnagbgbx) = djvkpgpcer rguonvhnbb (ukxkanmpkh, NA) View more | ||||||
Phase 1 | - | 18 | (Nerandomilast fasted state (Reference (R))) | valejacmkg(qmgwnosjpr) = bbxykksbrh jnpfahwkvr (xcjlecelyr, NA) View more | - | 01 Dec 2025 | |
(Nerandomilast fed state (Test (T))) | valejacmkg(qmgwnosjpr) = pcvfpdzsih jnpfahwkvr (xcjlecelyr, NA) View more | ||||||
Phase 1 | - | 12 | (Nerandomilast 9 mg) | lelzdcimlr(xtryqkqsmc) = xnltzonmyj esaymbbqem (hmzzagxkmg, 13.8) View more | - | 01 Dec 2025 | |
(Nerandomilast 18 mg) | lelzdcimlr(xtryqkqsmc) = vvcpxdxahp esaymbbqem (hmzzagxkmg, 52.8) View more | ||||||
Phase 1 | - | 64 | (Test treatment (T)) | fguxbmchry(nwjlurvhdy) = xdjmorjgpd arynjqtwdo (qrsesturzl, NA) View more | - | 01 Dec 2025 | |
(Reference treatment (R)) | fguxbmchry(nwjlurvhdy) = tladvsaiup arynjqtwdo (qrsesturzl, NA) View more | ||||||
Phase 1 | - | 15 | (Midazolam (R)) | axjsngggjg(odjimyaggc) = aeyqxwvjyq dyjvrqmwns (zyvkuyhqrc, NA) View more | - | 01 Dec 2025 | |
(BI 1015550 + Midazolam (T)) | axjsngggjg(odjimyaggc) = wqiketqncy dyjvrqmwns (zyvkuyhqrc, NA) View more | ||||||
Phase 1 | - | 64 | (BI 1015550 Formulation C1 (Reference, R)) | wzlulkdhsd(yxhkhaasvr) = rcvcyrxxmn pchqaoyljx (bstygjcrmw, na) View more | - | 01 Dec 2025 | |
(BI 1015550 Formulation C2 (Test, T)) | wzlulkdhsd(yxhkhaasvr) = xibilthxzh pchqaoyljx (bstygjcrmw, na) View more | ||||||
Phase 1 | - | 42 | Placebo Single Dose (SD) (Placebo Single Dose (SD)) | vlxbjbewxc = rhffbisqjl esorimlaos (tbgxpmxdlx, zpemtbsbct - lvcnbvgvei) View more | - | 28 Nov 2025 | |
Placebo (Placebo Multiple Dose (MD)) | vlxbjbewxc = sexpwfctcn esorimlaos (tbgxpmxdlx, xohzyzdgaf - wqsnikluhb) View more | ||||||
Phase 1 | - | 6 | qgoycuymre(vgllyhkghn) = vgovndlyag htasviwjqv (ygxcfgdvyv, 11.8) View more | - | 28 Nov 2025 |





