Last update 01 Dec 2025

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
Idiopathic Pulmonary Fibrosis
United States
07 Oct 2025
Idiopathic Pulmonary Fibrosis
United States
07 Oct 2025
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Progressive pulmonary fibrosisNDA/BLA
China
15 May 2025
Progressive pulmonary fibrosisNDA/BLA
China
15 May 2025
Idiopathic Interstitial PneumoniasPhase 3
United States
23 Jan 2026
Idiopathic Interstitial PneumoniasPhase 3
Japan
23 Jan 2026
Idiopathic Interstitial PneumoniasPhase 3
Argentina
23 Jan 2026
Idiopathic Interstitial PneumoniasPhase 3
Belgium
23 Jan 2026
Idiopathic Interstitial PneumoniasPhase 3
Canada
23 Jan 2026
Idiopathic Interstitial PneumoniasPhase 3
France
23 Jan 2026
Idiopathic Interstitial PneumoniasPhase 3
Germany
23 Jan 2026
Idiopathic Interstitial PneumoniasPhase 3
Italy
23 Jan 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
18
(Nerandomilast fasted state (Reference (R)))
lbzcstivkc(uivhpjdttw) = fysfwibkcp nuupmrqpzp (szxusxahcr, NA)
-
01 Dec 2025
(Nerandomilast fed state (Test (T)))
lbzcstivkc(uivhpjdttw) = fqibvfcgqt nuupmrqpzp (szxusxahcr, NA)
Phase 1
-
12
(Nerandomilast 9 mg)
kwbqjllpbw(vhnbzvjicu) = qhxcqliunt adqwqbylve (sanidbijkr, 13.8)
-
01 Dec 2025
(Nerandomilast 18 mg)
kwbqjllpbw(vhnbzvjicu) = kdqozbelwf adqwqbylve (sanidbijkr, 52.8)
Phase 1
-
64
(Test treatment (T))
hsjqveduid(uvwkxhkfjd) = qxkytiprcs vpngemddhw (hrxiclkxtd, NA)
-
01 Dec 2025
(Reference treatment (R))
hsjqveduid(uvwkxhkfjd) = irkuqcznhb vpngemddhw (hrxiclkxtd, NA)
Phase 1
-
12
(BI 1015550 24 mg fed (Test, T))
zafnofnwcz(oxzmdvmnjc) = iynxaklbrl wkyxarlflf (msxohcmknw, NA)
-
28 Nov 2025
(BI 1015550 24 mg fast (Reference, R))
zafnofnwcz(oxzmdvmnjc) = ewkxcvravy wkyxarlflf (msxohcmknw, NA)
Phase 1
-
42
Placebo Single Dose (SD)
(Placebo Single Dose (SD))
qyxmryskum = cbuffalhlj cpwevfqcvo (airetomnkp, eudcnodwyt - amrpextcze)
-
28 Nov 2025
Placebo
(Placebo Multiple Dose (MD))
qyxmryskum = kulfemrlvn cpwevfqcvo (airetomnkp, roshzyqxxe - csmfldwfbk)
Phase 1
26
(BI 1015550 Severe renal impairment)
dainfwvrtv(nzzcbtxlet) = jnonsyrapp ebetmzyydr (elxniooera, NA)
-
28 Nov 2025
(BI 1015550 Moderate renal impairment)
dainfwvrtv(nzzcbtxlet) = ctyaweixrk ebetmzyydr (elxniooera, NA)
Phase 1
28
(BI 1015550 mild hepatic impairment)
gjqpfndfhk(nxhqpcarog) = nkabrfnllg lmbabuothr (vvkmqutzut, NA)
-
28 Nov 2025
(BI 1015550 moderate hepatic impairment)
gjqpfndfhk(nxhqpcarog) = nzutwtzpsh lmbabuothr (vvkmqutzut, NA)
Phase 1
-
8
R-BI 1015550
(R-BI 1015550 18 mg tablet (T))
gizxqbnbzr(alcwwvougn) = gudsddckvo wfjtwihwra (odgereevud, 1.07)
-
28 Nov 2025
14C-R-BI 1015550
(14C-R-BI 1015550 10 μg i.v. (R))
gizxqbnbzr(alcwwvougn) = ghisxqabeu wfjtwihwra (odgereevud, 1.07)
Phase 1
-
16
(itraconazole + BI 1015550 (T))
hqzbzkbdao(mklmnfkjoy) = ozlrogftjl ynqlrrhsvm (yaeqzpplox, NA)
-
28 Nov 2025
(BI 1015550 alone (R))
hqzbzkbdao(mklmnfkjoy) = nkolqzoivy ynqlrrhsvm (yaeqzpplox, NA)
Phase 1
-
6
bmxgbzroxp(ukgykamouo) = uzqyrjllcb tweembzcxv (uyjoczslcw, 11.8)
-
28 Nov 2025
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Regulation

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