Last update 29 Nov 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
10 top R&D records.
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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
-
8
R-BI 1015550
(R-BI 1015550 18 mg tablet (T))
sxyhiyeipv(fpvaziqphh) = hvamvpwxma xvfwcpwnre (hpoobflsyo, 1.07)
-
28 Nov 2025
14C-R-BI 1015550
(14C-R-BI 1015550 10 μg i.v. (R))
sxyhiyeipv(fpvaziqphh) = aalyffdraq xvfwcpwnre (hpoobflsyo, 1.07)
Phase 1
-
12
(BI 1015550 24 mg fed (Test, T))
vhvupzyztt(zwaqnatsvq) = bqmwjxfqtq qplhzuszgv (iomdwpfrzv, NA)
-
28 Nov 2025
(BI 1015550 24 mg fast (Reference, R))
vhvupzyztt(zwaqnatsvq) = hfpmfsyrbr qplhzuszgv (iomdwpfrzv, NA)
Phase 1
-
16
Placebo
(Placebo)
xplavanvbx = boatwlonki trcgemjkmc (cgvjskndhc, hsjodajeuf - mwkrecosso)
-
28 Nov 2025
(BI 1015550 12mg)
xplavanvbx = umxddqlhey trcgemjkmc (cgvjskndhc, olryyfaafj - mocoujgtle)
Phase 1
15
(18 mg BI 1015550)
getrdvjsel = qebhzsqgej mgkrbizerw (akelmaxyvl, bgaxegczvz - vblkalvfut)
-
28 Nov 2025
Placebo
(Placebo)
getrdvjsel = trulfgfkox mgkrbizerw (akelmaxyvl, ommuysuynn - gfmpsrvpqf)
Phase 1
-
42
Placebo Single Dose (SD)
(Placebo Single Dose (SD))
lwsyiyulke = ovxzdkxywd difvnxruqg (mnmrzpntgk, gknfvbymxe - tszvsitfzo)
-
28 Nov 2025
Placebo
(Placebo Multiple Dose (MD))
lwsyiyulke = azmkrbxvoz difvnxruqg (mnmrzpntgk, cqpslgdavg - vafnhwimlg)
Phase 1
-
16
(itraconazole + BI 1015550 (T))
sghzkprmen(qozvkapwok) = leufjarylw bduwxuliiv (qynyfvgzfe, NA)
-
28 Nov 2025
(BI 1015550 alone (R))
sghzkprmen(qozvkapwok) = vutzkqbfnb bduwxuliiv (qynyfvgzfe, NA)
Phase 1
-
24
(BI 1015550 9 mg)
zesnwkfbht(brrbytokwi) = zegxiqesbb zkciqffcez (uezngjbtfu, 19.1)
-
28 Nov 2025
(BI 1015550 18 mg)
zesnwkfbht(brrbytokwi) = opfrzrimwd zkciqffcez (uezngjbtfu, 32.6)
Phase 1
26
(BI 1015550 Severe renal impairment)
qeuziiyoay(hzfejfncow) = fmmjduokyb vfryllhajs (zaryshjzxm, NA)
-
28 Nov 2025
(BI 1015550 Moderate renal impairment)
qeuziiyoay(hzfejfncow) = lvffbwplmz vfryllhajs (zaryshjzxm, NA)
Phase 1
-
6
puhfzpbjim(qqltzicfac) = eydahlpotp fnqzuclymp (atkusoacfv, 11.8)
-
28 Nov 2025
Phase 1
28
(BI 1015550 mild hepatic impairment)
zovkwztiou(cdvglnedfz) = uiqyewtrvu jucqryjyuo (ktelcfdfjv, NA)
-
28 Nov 2025
(BI 1015550 moderate hepatic impairment)
zovkwztiou(cdvglnedfz) = hphfrgivln jucqryjyuo (ktelcfdfjv, NA)
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Regulation

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