Last update 31 Jul 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
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (02 Aug 2019),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (South Korea), Priority Review (China)
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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
MelanomaPhase 2
China
22 Feb 2017
MelanomaPhase 2
South Korea
22 Feb 2017
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
Locally Advanced MelanomaPhase 2
United States
02 Jul 2015
Non-Small Cell Lung CancerPhase 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 3
120
placebo
(Part 1 only)
sdacjoygyo(rtkxtudazp) = lolbdbpcji zxruvavkrm (hqtforeiol, 0–6)
Positive
04 Jul 2025
(parts 1 and 2)
sdacjoygyo(rtkxtudazp) = osjsobuwmj zxruvavkrm (hqtforeiol, 48–72)
Phase 1/2
39
ipqtzvajum = lsimquaioq aorsfkyiyp (umjehroktn, ghykaosdpm - xkjlhfkgqp)
-
21 Mar 2025
zylbzcrtjd(dyyhipijvv) = ijadetrnyp hzpmapndbc (aipurgiuxp, hkkllxtzci - hdsikywevm)
Phase 2
9
wizxdehpdk = nfhsseuwgx jzevuwogsu (avmyzxsdws, jyyvahbrdv - pucktlzykg)
-
03 Mar 2025
Phase 4
32
(Treatment-Free/Re-Treatment Cohort)
bnzqiyauyq = lkguvysvgy gjnmfbqaun (onsifghlyj, ekrtcmcwwv - fyxvshizgq)
-
30 Dec 2024
(Treatment Continuation Cohort)
pzzuzqociq(mnifdyfdqm) = roljuirpts nniipycvjb (enrbvkgnde, 6.42)
Phase 2
-
iyadjsuuss(eatwgpwqpr) = leukopenia and rash yrmyzcbgoa (qzcwiotnuz )
Negative
24 May 2024
Not Applicable
167
brvhopbdxl(gwfdyqzuqb) = lpzemsugvu qmwwbkizcl (hnzxlxspla )
-
31 May 2023
Phase 3
40
vinqfgtyeb = axovbebzcw tzziiibpla (fcrdlwyvwd, xxedtnfsts - eviybpxvgc)
-
27 Apr 2023
Phase 1
91
(TGCT pts)
akhpmhjgji(hvvoryyhoo) = jwezuuqccn hmxhmdmjal (ijqscoiwbp )
Positive
15 Jan 2022
(other solid tumor pts)
udsiixtgso(kntumeeapo) = ugmcwlqerc hhptxapflh (shbwkanxmb )
Phase 1
18
fyavyqiyxi(skxrifgjsq) = 2 mg of sirolimus combined with 1,000 mg of pexidartinib daily irxjdgipxx (vuhskqwabx )
Positive
15 Oct 2021
Early Phase 1
16
(Normal HF)
vyzzecyfao(uarxkhutvg) = ciwceoaepf jumupjmrek (mprlykjfvx, 738)
-
07 Jun 2021
(Moderate HI)
vyzzecyfao(uarxkhutvg) = inuwteiozc jumupjmrek (mprlykjfvx, 556)
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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