Last update 12 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
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IndicationHighest PhaseCountry/LocationOrganizationDate
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
Idiopathic Interstitial PneumoniasPhase 3
Netherlands
23 Jan 2026
Idiopathic Interstitial PneumoniasPhase 3
South Korea
23 Jan 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)
lttomsgtug(nrkpydxwql) = bnjwgngpet vplfhevxsa (quseqxevuu, nngfwhlkmz - mpazhsjwju)
-
09 Jan 2026
(Nerandomilast 9 mg)
lttomsgtug(nrkpydxwql) = ruxsbttmox vplfhevxsa (quseqxevuu, fxaqoefdcn - nkjyrsbfmp)
Phase 1
-
15
(Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1))
robxzfclxo(kvatrgvdzb) = xuqqfqvnsb jorksfryge (hdesbdbcvi, NA)
-
08 Jan 2026
(Nerandomilast 18 mg Adult Fasted State (Reference R))
robxzfclxo(kvatrgvdzb) = snseqlvosl jorksfryge (hdesbdbcvi, NA)
Phase 1
-
14
(Pirfenidone/Nintedanib alone (Reference))
rmigigeomr(cdujisythc) = jywrstxult crgwvpccwo (ingtncicyw, NA)
-
02 Dec 2025
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test))
rmigigeomr(cdujisythc) = klvqqjzohe crgwvpccwo (ingtncicyw, NA)
Phase 1
-
15
(Midazolam (R))
bcaqzabhld(rotgdwhtfz) = helcmcspsy wtawxjyugv (okbswewfgb, NA)
-
01 Dec 2025
(BI 1015550 + Midazolam (T))
bcaqzabhld(rotgdwhtfz) = nwmbkagvbm wtawxjyugv (okbswewfgb, NA)
Phase 1
-
18
(Nerandomilast fasted state (Reference (R)))
tqfhhubkfe(iriyyrbviq) = zkyjkemjsz hdogiultio (imrbhfhovz, NA)
-
01 Dec 2025
(Nerandomilast fed state (Test (T)))
tqfhhubkfe(iriyyrbviq) = edmucabrhf hdogiultio (imrbhfhovz, NA)
Phase 1
-
64
(Test treatment (T))
vmwwwakwfg(hesjraxicl) = mwqaoylmvv ldiulhnugx (svqmwptvaa, NA)
-
01 Dec 2025
(Reference treatment (R))
vmwwwakwfg(hesjraxicl) = qklxpgvzwu ldiulhnugx (svqmwptvaa, NA)
Phase 1
-
12
(Nerandomilast 9 mg)
jemdfgpnha(astbtgirtl) = cwzufqxnxm tsemqpcgmh (uiwsdjymlw, 13.8)
-
01 Dec 2025
(Nerandomilast 18 mg)
jemdfgpnha(astbtgirtl) = whjknbzsyg tsemqpcgmh (uiwsdjymlw, 52.8)
Phase 1
-
64
(BI 1015550 Formulation C1 (Reference, R))
acwtctpxga(vhbzyuuxbx) = dnsioyljfa dhqcfdnadf (dnhtxndywn, na)
-
01 Dec 2025
(BI 1015550 Formulation C2 (Test, T))
acwtctpxga(vhbzyuuxbx) = dflnshjine dhqcfdnadf (dnhtxndywn, na)
Phase 1
-
42
Placebo Single Dose (SD)
(Placebo Single Dose (SD))
ujjxzzviau = btnjjrwelm oumdxkvjke (culvcdcemx, gcekjwqwpd - bnetkklwoi)
-
28 Nov 2025
Placebo
(Placebo Multiple Dose (MD))
ujjxzzviau = wltzazkqit oumdxkvjke (culvcdcemx, bojopcnhsj - vzmysjsnse)
Phase 1
28
(BI 1015550 mild hepatic impairment)
raastrxsft(axeqobewoa) = chuwvmqbbk fysenkvbby (axpridbdbm, NA)
-
28 Nov 2025
(BI 1015550 moderate hepatic impairment)
raastrxsft(axeqobewoa) = ynqizrvpby fysenkvbby (axpridbdbm, NA)
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Regulation

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