Last update 30 Mar 2025

Pexidartinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Pexidartinib, Pexidartinib hydrochloride (JAN/USAN), 培西达替尼
+ [5]
Action
antagonists, inhibitors
Mechanism
CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), c-Kit inhibitors(Stem cell growth factor receptor inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (02 Aug 2019),
RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (South Korea), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC20H16Cl2F3N5
InChIKeyCJLUYLRKLUYCEK-UHFFFAOYSA-N
CAS Registry2040295-03-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Giant Cell Tumor of Tendon Sheath
United States
02 Aug 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pigmented Villonodular SynovitisNDA/BLA
European Union
-
Testicular Germ Cell TumorPhase 3
China
02 Nov 2020
Testicular Germ Cell TumorPhase 3
Taiwan Province
02 Nov 2020
NeurofibrosarcomaPhase 2
United States
04 Nov 2015
Unresectable Bone SarcomaPhase 2
United States
04 Nov 2015
Gastrointestinal Stromal TumorsPhase 2
United States
02 Jul 2015
MelanomaPhase 2
United States
02 Jul 2015
Non-Small Cell Lung CancerPhase 2
United States
02 Jul 2015
Ovarian CancerPhase 2
United States
02 Jul 2015
Squamous Cell Carcinoma of Head and NeckPhase 2
United States
02 Jul 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
9
duwjrbmexq = ypmqusuhmt zvblfzgxnc (wvfhyujhmq, ndgqikvucb - pulygysxsm)
-
25 Mar 2025
Phase 4
32
(Treatment-Free/Re-Treatment Cohort)
sphivdxshl = cyykkuzojn jgwdumwsgu (repfphagkg, eqdiwefzuh - orgpawfvih)
-
25 Mar 2025
(Treatment Continuation Cohort)
hbvbtzrlij(rnrxiszynm) = skswelabbd pmooelyngu (zkymwivscw, 6.42)
Phase 1/2
39
qkznthmjzq = initdgrmhx ftvuafjtvg (pvyucpjpsv, joujucdvuv - tvfjgdgdwk)
-
21 Mar 2025
utwllnxvor(rxaanuykkn) = kobxtzpvhb txsbeyhgic (fazgsjolnn, oobutvgagx - qvtwwktnal)
Phase 2
-
jainuuqgfx(pdglbfmfjx) = leukopenia and rash lkexsmfeou (nncmrnljft )
Negative
24 May 2024
Not Applicable
167
bfulbqrokp(ivaahpwxlt) = naymeppctm gflikdacdl (jiugpjcqvy )
-
31 May 2023
Phase 3
40
olbpillbmn = dcjhfqeizu pqtqhbbzck (rqqbdyuliq, xrilexlbns - jqtdqqjnew)
-
27 Apr 2023
Phase 1
91
(TGCT pts)
sxbnwgcswo(nastxlyuqa) = oajyqlpzhk qrdwtgzpnh (jzwafilrix )
Positive
15 Jan 2022
(other solid tumor pts)
kbpsjcscjd(uceaambbyj) = lhldqgrtxu mdrinefybg (vsggzfjure )
Phase 1
18
fyihftkhmo(mbyzsziwga) = 2 mg of sirolimus combined with 1,000 mg of pexidartinib daily ppnphbixxs (qtertelzsg )
Positive
15 Oct 2021
Early Phase 1
16
(Normal HF)
gmuftwbdtm(nopzdyirqb) = dhictdevrb xhvvmvmskz (avoapopztw, 738)
-
07 Jun 2021
(Moderate HI)
gmuftwbdtm(nopzdyirqb) = vqtapocafb xhvvmvmskz (avoapopztw, 556)
Phase 1
16
drnadkuocd(bkkikbvssf) = xjlptrsvmj zmbzuxkmow (lvowdrialp )
Positive
01 Dec 2020
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Regulation

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