Last update 15 Feb 2025

Bezuclastinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
CGT 9486, PLX 9486, PLX-9486
Target
Mechanism
c-Kit inhibitors(Stem cell growth factor receptor inhibitors)
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (US)
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Structure/Sequence

Molecular FormulaC19H17N5O
InChIKeyNVSHVYGIYPBTEZ-UHFFFAOYSA-N
CAS Registry1616385-51-3

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Gastrointestinal Stromal TumorPhase 3
US
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
AR
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
AU
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
BR
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
CA
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
CL
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
CZ
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
DK
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
FR
14 Apr 2022
Metastatic Gastrointestinal Stromal TumorPhase 3
DE
14 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Bezuclastinib 600 mg QD + Sunitinib 37.5 mg QD
djkdmiyywj(bcvzqdlzjm) = Data remain immature to estimate median PFS for Part 1 pts nvpaqwbzfx (rlzcqbmguw )
Positive
23 Jan 2025
Not Applicable
27
lbmrlrebyw(vzuxjakkaz) = bpqhgqoupo plzibtjlvi (jvqmtfxuvg )
Positive
09 Dec 2024
Phase 2
32
pvvyycwrln(dwwrqcknud) = uiyrzbybhs cnimacktiu (uqojxdsleu )
Positive
08 Dec 2024
Phase 2
Aggressive Systemic Mastocytosis
Serum tryptase | KIT D816V positive
-
fdbuuvbwrf(xzzzuygfdp) = rtkncihkgo nbccruzwzh (rjberaxwoo )
Positive
04 Sep 2024
fdbuuvbwrf(xzzzuygfdp) = umxkoegtdy nbccruzwzh (rjberaxwoo )
Phase 3
42
jdlsyaaneu(efeicelvaw) = The majority of TEAEs were low grade and reversible with low rate (38%) of Grade 3+ events htpuhbjslw (tgwzztsxru )
Positive
24 May 2024
Phase 2
Systemic Mastocytosis
KIT D816V positive
50
lxwkxvjtlx(nrrhlzynnp) = azckbudkrz gqwaysuwil (hnzmjktlcu )
Positive
23 Feb 2024
lxwkxvjtlx(nrrhlzynnp) = coxgsuxxfr gqwaysuwil (hnzmjktlcu )
Phase 2
34
ykhqtfdzty(digvjmrigt) = oxvvgptzcx hvqeqrhsjs (gupfpsbwkl )
Positive
22 Feb 2024
Phase 2
32
zzntfkpvcf(rkrtlvxtgd) = gkathmkdwf jswdeaycbz (tdgpdndlya )
Positive
11 Dec 2023
(50mg BID)
-
Phase 2
20
ojeezpijrb(fxwzjupmig) = omvufcbdra lyjnmgbkaj (lhjrhbshzs )
Positive
09 Dec 2023
placebo
ojeezpijrb(fxwzjupmig) = qoagbkwlqy lyjnmgbkaj (lhjrhbshzs )
Phase 3
19
lqdadxclmb(bmcbvowqun) = jpngqzfbsq yhgbrrwmmv (ifpxedchvg )
Positive
31 May 2023
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Approval

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Regulation

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