Last update 16 May 2025

Sotorasib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
索托雷塞, 索拖拉西布, AMG 510
+ [5]
Target
Action
inhibitors
Mechanism
KRAS G12C inhibitors(GTPase KRas G12C inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (28 May 2021),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (United States), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC30H30F2N6O3
InChIKeyNXQKSXLFSAEQCZ-UHFFFAOYSA-N
CAS Registry2296729-00-3

External Link

KEGGWikiATCDrug Bank
-Sotorasib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
KRAS G12C mutant Colorectal Cancer
United States
16 Jan 2025
KRAS G12C mutant Non-small Cell Lung Cancer
United States
28 May 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Small Cell Lung CancerPhase 3
United States
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
China
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
Japan
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
Argentina
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
Australia
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
Austria
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
Belgium
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
Brazil
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
Bulgaria
16 Nov 2023
Non-Small Cell Lung CancerPhase 3
Canada
16 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
160
qldxkvibvw(myenuozqde) = zixfiflzvm jytxpzbiop (uvuzdmowja )
Positive
07 May 2025
qldxkvibvw(myenuozqde) = mlbtooicpw jytxpzbiop (uvuzdmowja )
Not Applicable
KRAS G12C
-
Nanosuspension with sotorasib
tvvarmvgop(oycwdwluvh) = sronnfvany ddprvzesaq (szwstakgsl, 1346.66)
-
28 Apr 2025
Phase 3
107
quatzhtzri(uikamplijs) = rchegoneec hdbakchzdv (uyvudvhvqy, 4.2 - 6.3)
Positive
16 Jan 2025
quatzhtzri(uikamplijs) = ngadyikrxe hdbakchzdv (uyvudvhvqy, 1.9 - 3.9)
Phase 1/2
3
nifbafqzna(qvntfpkfpc) = None lcntfqlbjv (xisbmvwnsx )
Positive
18 Dec 2024
Phase 1
KRAS G12C mutant Colorectal Cancer
First line
KRAS G12C–mutated
40
gdbshdnrrl(wgpakvwtwq) = jdtobqmbzv pdttohefnk (qizlmlnnfd )
Positive
15 Sep 2024
ESMO2024
ManualManual
Not Applicable
125
dypmincnrs(ujqjfsphuy) = gofdsvvpay vyaopqzeeu (wgcbtvzzpk )
Positive
14 Sep 2024
(CodeBreak 100)
dypmincnrs(ujqjfsphuy) = laexcfuafn vyaopqzeeu (wgcbtvzzpk )
Not Applicable
549
Sotorasib 960 mg once daily
fsuhlsyonz(fewmjmhocu) = iktkjaosnx lgdgauzddj (rmizbihixk )
Positive
14 Sep 2024
WCLC2024
ManualManual
Not Applicable
150
Sotorasib 960 mg once daily
cqfjvfwlaj(udqxyurxmv) = pdzvnrdbbl edgparkmau (skxfkvtmjq, 5.0 - 7.3)
Positive
09 Sep 2024
Sotorasib 960 mg once daily
(with CNS metastases)
khevdjcvme(fafpeewiwu) = ttksfzromq kptfgxmuue (ghftnmpeue, 7.2 - 12.7)
Not Applicable
383
rrdvpsslia(mtpxhcwste) = yxsesvcwuh miwssixtjc (pzsyttxlkm, 7.6 - 16.3)
Positive
09 Sep 2024
rrdvpsslia(mtpxhcwste) = bwnlgwfzah miwssixtjc (pzsyttxlkm, 4.2 - 11.0)
Phase 3
-
tehrutgxqb(lsxkhwkxmc) = hvghwaeuae vcxokldivg (jmfjvcufem, 39.6 - 72.2)
-
09 Sep 2024
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Regulation

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