Last update 17 Feb 2026

Nerandomilast

Overview

Basic Info

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)
Inactive Indication-
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)
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Structure/Sequence

Molecular FormulaC20H25ClN6O2S
InChIKeyUHYCLWAANUGUMN-SSEXGKCCSA-N
CAS Registry1423719-30-5

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Progressive pulmonary fibrosis
China
09 Dec 2025
Idiopathic Pulmonary Fibrosis
United States
07 Oct 2025
Idiopathic Pulmonary Fibrosis
United States
07 Oct 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic Interstitial PneumoniasPhase 3
United States
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
Japan
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
Argentina
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
Australia
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
Belgium
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
Canada
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
France
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
Germany
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
Italy
10 Feb 2026
Idiopathic Interstitial PneumoniasPhase 3
Netherlands
10 Feb 2026
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Clinical Result

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

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