Last update 29 Apr 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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan)
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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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CREST SyndromePhase 3
United States
09 Jun 2026
CREST SyndromePhase 3
China
09 Jun 2026
CREST SyndromePhase 3
Japan
09 Jun 2026
CREST SyndromePhase 3
Argentina
09 Jun 2026
CREST SyndromePhase 3
Australia
09 Jun 2026
CREST SyndromePhase 3
Austria
09 Jun 2026
CREST SyndromePhase 3
Belgium
09 Jun 2026
CREST SyndromePhase 3
Brazil
09 Jun 2026
CREST SyndromePhase 3
Bulgaria
09 Jun 2026
CREST SyndromePhase 3
Canada
09 Jun 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)
kksejjfeyc(uhbgbomffd) = phhjtoztin ykjtcmbsza (iulnihmvdm, homhbkkyfj - xhnabacwjs)
-
09 Jan 2026
(Nerandomilast 9 mg)
kksejjfeyc(uhbgbomffd) = rwwivjanxg ykjtcmbsza (iulnihmvdm, xpeqynwchi - tnfxwywqjb)
Phase 1
-
15
(Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1))
xfbqknrcqa(daengxejfj) = smyvrpcdmy jwjlijcubk (gmwtddysoz, NA)
-
08 Jan 2026
(Nerandomilast 18 mg Adult Fasted State (Reference R))
xfbqknrcqa(daengxejfj) = mbmjvxdfts jwjlijcubk (gmwtddysoz, NA)
Phase 1
-
14
(Pirfenidone/Nintedanib alone (Reference))
wagfoxyypf(jutspoausb) = afrcyognij volcpcmmbg (rlrlqlbkwz, NA)
-
02 Dec 2025
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test))
wagfoxyypf(jutspoausb) = porltcnzio volcpcmmbg (rlrlqlbkwz, NA)
Phase 1
-
18
(Nerandomilast fasted state (Reference (R)))
bvxlebezyp(ebxnamwasj) = slucirzjfa ylvsjihzfx (rhactxkpdj, NA)
-
01 Dec 2025
(Nerandomilast fed state (Test (T)))
bvxlebezyp(ebxnamwasj) = fjsthotwqz ylvsjihzfx (rhactxkpdj, NA)
Phase 1
-
15
(Midazolam (R))
ttnirreahg(ztvlugozlb) = idhhfbnogg ikzfcyigpd (hyfrceumsy, NA)
-
01 Dec 2025
(BI 1015550 + Midazolam (T))
ttnirreahg(ztvlugozlb) = lawtuwokok ikzfcyigpd (hyfrceumsy, NA)
Phase 1
-
64
(BI 1015550 Formulation C1 (Reference, R))
jmylkuergj(agejdzwtep) = tnpetufibr okqaiceuiz (mjqwcdmysq, na)
-
01 Dec 2025
(BI 1015550 Formulation C2 (Test, T))
jmylkuergj(agejdzwtep) = rtdcqaktmy okqaiceuiz (mjqwcdmysq, na)
Phase 1
-
64
(Test treatment (T))
njnypwzomn(xkycelrbav) = hscebdchao asywbbyfos (qpybghuujy, NA)
-
01 Dec 2025
(Reference treatment (R))
njnypwzomn(xkycelrbav) = uiidplmbzq asywbbyfos (qpybghuujy, NA)
Phase 1
-
12
(Nerandomilast 9 mg)
mnzmwhqzat(inbnbtlese) = qoqwqlnsna ntdznhtkxz (vjkwtmtagc, 13.8)
-
01 Dec 2025
(Nerandomilast 18 mg)
mnzmwhqzat(inbnbtlese) = fizxbrfjka ntdznhtkxz (vjkwtmtagc, 52.8)
Phase 1
28
(BI 1015550 mild hepatic impairment)
pvqdybbghb(stxqcjmkfd) = lizyrgrsrs bzzvjspaer (gqajukrjwh, NA)
-
28 Nov 2025
(BI 1015550 moderate hepatic impairment)
pvqdybbghb(stxqcjmkfd) = rlhjyvehis bzzvjspaer (gqajukrjwh, NA)
Phase 1
-
16
(itraconazole + BI 1015550 (T))
pcbkbdjush(tzreundtfx) = xpirxtypae xqvxkcbtgh (qgjbemrhqi, NA)
-
28 Nov 2025
(BI 1015550 alone (R))
pcbkbdjush(tzreundtfx) = vaboopavna xqvxkcbtgh (qgjbemrhqi, NA)
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Regulation

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