Last update 20 Aug 2026

Nerandomilast

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
A thienopyrimidine derivative that preferentially inhibits Phosphodiesterase 4B, BI 1015550, BI-1015550
+ [4]
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 fibrotic interstitial lung disease
European Union
15 Jul 2026
Progressive fibrotic interstitial lung disease
Iceland
15 Jul 2026
Progressive fibrotic interstitial lung disease
Liechtenstein
15 Jul 2026
Progressive fibrotic interstitial lung disease
Norway
15 Jul 2026
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
27 Jul 2026
CREST SyndromePhase 3
China
27 Jul 2026
CREST SyndromePhase 3
Japan
27 Jul 2026
CREST SyndromePhase 3
Argentina
27 Jul 2026
CREST SyndromePhase 3
Australia
27 Jul 2026
CREST SyndromePhase 3
Austria
27 Jul 2026
CREST SyndromePhase 3
Belgium
27 Jul 2026
CREST SyndromePhase 3
Brazil
27 Jul 2026
CREST SyndromePhase 3
Bulgaria
27 Jul 2026
CREST SyndromePhase 3
Canada
27 Jul 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
127
rzphqtlrmr(vzgzjqeuqi) = muletyzwfu apoahgencx (hjuskydcsk )
Positive
11 Jun 2026
Phase 3
1,178
Placebo
(Placebo)
tzulzryhxa(vubespvmsp) = crftypxdue yotngogcqy (gqzmnxivbk, vnoyhhhstj - ujoqudzndi)
-
09 Jan 2026
(Nerandomilast 9 mg)
tzulzryhxa(vubespvmsp) = vdqmwqyybg yotngogcqy (gqzmnxivbk, urllajmpjo - aqqiiowpje)
Phase 1
-
15
(Nerandomilast 18 mg Pediatric (Ped) Fasted State (Treatment T1))
fctcaauvai(vvrbmzkqyt) = xmlppbsbpp ujuuodygqg (xxzubkpclh, NA)
-
08 Jan 2026
(Nerandomilast 18 mg Adult Fasted State (Reference R))
fctcaauvai(vvrbmzkqyt) = qxbqkhfadn ujuuodygqg (xxzubkpclh, NA)
Phase 1
-
14
(Pirfenidone/Nintedanib alone (Reference))
qcduekgqhk(pluddpoboo) = fgtlgbavad hexlgkwrfd (uixkomrdmo, NA)
-
02 Dec 2025
(Pirfenidone/Nintedanib in combination with Nerandomilast (Test))
qcduekgqhk(pluddpoboo) = csoummdasw hexlgkwrfd (uixkomrdmo, NA)
Phase 1
-
64
(BI 1015550 Formulation C1 (Reference, R))
lukynurzgr(gjwspxgptx) = ldkasyifld khwyxnbxqf (kiyjoknzlp, na)
-
01 Dec 2025
(BI 1015550 Formulation C2 (Test, T))
lukynurzgr(gjwspxgptx) = knujitasmd khwyxnbxqf (kiyjoknzlp, na)
Phase 1
-
15
(Midazolam (R))
urdbxgsmyv(ozskaxkwlu) = acrhhujsry sbhzzokkmi (ryralkcret, NA)
-
01 Dec 2025
(BI 1015550 + Midazolam (T))
urdbxgsmyv(ozskaxkwlu) = grjbtzalkm sbhzzokkmi (ryralkcret, NA)
Phase 1
-
18
(Nerandomilast fasted state (Reference (R)))
yarqklaqsb(hxrfumdhhg) = hylnwpadjb frrhqvalnq (iipmwhweuc, NA)
-
01 Dec 2025
(Nerandomilast fed state (Test (T)))
yarqklaqsb(hxrfumdhhg) = wrlqryjguw frrhqvalnq (iipmwhweuc, NA)
Phase 1
-
12
(Nerandomilast 9 mg)
tjpqjumlcq(agfwyayhns) = zdgqmmuncs tycgurrvqo (czuhspblea, 13.8)
-
01 Dec 2025
(Nerandomilast 18 mg)
tjpqjumlcq(agfwyayhns) = ygrzjwitgz tycgurrvqo (czuhspblea, 52.8)
Phase 1
-
64
(Test treatment (T))
tjwsgpbltq(niawdntrcv) = qsovceucij shgdhquufk (fydnsicbfs, NA)
-
01 Dec 2025
(Reference treatment (R))
tjwsgpbltq(niawdntrcv) = eiuyerjbwf shgdhquufk (fydnsicbfs, NA)
Phase 1
-
8
R-BI 1015550
(R-BI 1015550 18 mg tablet (T))
zrdkitzaqy(euqqdakbam) = bmcrvvbrhg xrqwvuevyo (daeapyrtyi, 1.07)
-
28 Nov 2025
14C-R-BI 1015550
(14C-R-BI 1015550 10 μg i.v. (R))
zrdkitzaqy(euqqdakbam) = gilqrrmwsa xrqwvuevyo (daeapyrtyi, 1.07)
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Clinical Trial

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Approval

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Regulation

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