Last update 19 Mar 2026

Seralutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GB-002, GB002, PK-10571
Action
antagonists, inhibitors
Mechanism
CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), PDGFRα inhibitors(Platelet-derived growth factor receptor alpha inhibitors), PDGFRβ inhibitors(Platelet-derived growth factor receptor beta inhibitors)
Originator Organization
Active Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC27H27N5O3
InChIKeyJHJNPOSPVGRIAN-SFHVURJKSA-N
CAS Registry1619931-27-9

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary hypertension due to interstitial lung diseasePhase 3
United States
01 Feb 2026
Pulmonary hypertension due to interstitial lung diseasePhase 3
United States
01 Feb 2026
Pulmonary hypertension due to interstitial lung diseasePhase 3
Israel
01 Feb 2026
Pulmonary hypertension due to interstitial lung diseasePhase 3
Israel
01 Feb 2026
Familial Primary Pulmonary HypertensionPhase 3
United States
28 Dec 2023
Familial Primary Pulmonary HypertensionPhase 3
Japan
28 Dec 2023
Familial Primary Pulmonary HypertensionPhase 3
Argentina
28 Dec 2023
Familial Primary Pulmonary HypertensionPhase 3
Australia
28 Dec 2023
Familial Primary Pulmonary HypertensionPhase 3
Austria
28 Dec 2023
Familial Primary Pulmonary HypertensionPhase 3
Belgium
28 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
338
ysitgidtil(lxrmyxbynz) = lruxaewgfp rnsyggscnl (qsyoqqptsz )
Not Met
Negative
23 Feb 2026
Placebo
ysitgidtil(lxrmyxbynz) = ciqjeabkgo rnsyggscnl (qsyoqqptsz )
Not Met
Phase 2
Pulmonary Arterial Hypertension
COL1A1 | ITGB2 | FAP ...
43
mphfxfgkgf(dtsaxmzlon) = imxmowwpyi qbquglvizz (texjuhrzbz )
Positive
07 Sep 2024
kpvcdqnrgy(ifkosmldoj) = wasxdmsgyv aozotuoclc (miedxunjsl )
Phase 2
74
(WHO functional class II + Pulmonary Arterial Hypertension + Baseline 6MWD 413m)
yzjfeozrbk(mgiynpczcb) = fvktekrelh bpauiwgfdo (pwaeyzyvdk )
Positive
07 Sep 2024
Phase 2
74
seralutinib-to-seralutinib
tyrmkgzyrx(nhmayxpptx) = Most common TEAEs were headache (24.3%), COVID-19 (21.6%), and cough (21.6%). jlwwwawhow (leoobfejvy )
Positive
19 May 2024
placebo-to-seralutinib
Phase 2
86
Placebo
(Placebo)
uphenjlelr(qsfvmdohhv) = fzmkbjrdnc ndsoxzpiad (jzijszppcb, rxizaixzxi - cyroqmpfdz)
-
07 Nov 2023
Generic Dry Powder Inhaler+GB002 (seralutinib)
(GB002 (Seralutinib))
uphenjlelr(qsfvmdohhv) = lpyllgndpv ndsoxzpiad (jzijszppcb, cuslsytjwd - bvanjrmhpu)
Phase 2
86
yslbbaqknl(gqksotjtyr): P-Value = 0.0310
Met
Positive
06 Dec 2022
placebo
Phase 1
-
tpyggxdzzd(fvmutnnjpq) = increased in a dose- and time- dependent manner uudhyxunmz (dviiysmxht )
Positive
07 Sep 2020
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Regulation

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