Last update 28 Mar 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 3-09 Jun 2026
Scleroderma, DiffusePhase 3-09 Jun 2026
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
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Clinical Result

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

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Clinical Trial

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Approval

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Regulation

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