Last update 11 Jul 2024

Samotolisib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mechanism
Class I PI3K inhibitors(PI3-kinase class I inhibitors), mTOR inhibitors(Serine/threonine-protein kinase mTOR inhibitors)
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
Regulation-

Structure

Molecular FormulaC23H26N4O3
InChIKeyACCFLVVUVBJNGT-AWEZNQCLSA-N
CAS Registry1386874-06-1

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Endometrial CancerPhase 3
US
01 Sep 2015
Non-Small Cell Lung CancerPhase 3
IT
31 Jul 2012
Non-Small Cell Lung CancerPhase 3
PR
31 Jul 2012
Metastatic Triple-Negative Breast CarcinomaPhase 2
US
05 Sep 2019
metastatic non-small cell lung cancerPhase 2
US
01 Jul 2015
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPhase 2
US
01 Jul 2015
squamous cell lung carcinomaPhase 2
US
01 Jul 2015
Metastatic castration-resistant prostate cancerPhase 2
US
29 Apr 2015
Prostatic cancer metastaticPhase 2
US
29 Apr 2015
Mesothelioma, MalignantDiscovery
PR
31 Jul 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
(pzrtxthglm) = hjjtgftpdn alwsumzinf (lakywyatqk, ipmfrffqyy - hogsgloehs)
-
11 Sep 2023
Phase 2
28
(tuuarejrpa) = mrghqgkyhj tygejbcoia (tyuskcqxrj, alzcphxzrd - mpqrgcmllq)
-
22 Feb 2023
Phase 1/2
142
wvlebkijbi(qfjhixmpiy) = mywnsfjdzt ceunjunmhr (jbzguyzfuv )
Positive
01 Apr 2022
Placebo + Enzalutamide
wvlebkijbi(qfjhixmpiy) = tvfnxdwtne ceunjunmhr (jbzguyzfuv )
Phase 1
42
(jzodbmkjjb) = 200 mg twice daily(BID) iiwqtwgrrt (ccryeqpfyq )
Positive
01 Aug 2021
Phase 2
142
(Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD)
ifzgmxndbg(yhxdkaszls) = eqznqdeapx pcpzhodxgy (ovyhygqcql, nljysdmnwi - rxiwdtpotq)
-
11 May 2021
Placebo+Enzalutamide
(Part B: Placebo + 160 mg Enzalutamide QD)
ifzgmxndbg(yhxdkaszls) = nruzdwejjv pcpzhodxgy (ovyhygqcql, jmsktqpsep - xjypyunbwg)
Phase 1
63
(uefjbbigoq) = ssftyemxma jzmjgvgzna (jxurebfyvs )
Negative
08 Mar 2021
(uefjbbigoq) = qeouqfhthc jzmjgvgzna (jxurebfyvs )
Phase 2
31
(Lead in Cohort LY3023414 + Necitumumab)
fbdqrozrxw(ofzrbkoiac) = rcxqawtgnz zoognrffqu (hanpglutrx, luvnwpgnrb - pqpntntlsp)
-
09 Dec 2020
(Post Lead in Cohort LY3023414 + Necitumumab)
fbdqrozrxw(ofzrbkoiac) = xgceeftjya zoognrffqu (hanpglutrx, ixjirdxyim - mhbjpvvfwp)
Phase 1
12
(bbreepwqil) = 200 mg LY3023414 for 2 patients with Grade 3 stomatitis fzinmidgjb (nkpsvjoagc )
Positive
01 Dec 2020
Phase 2
Endometrial Carcinoma
Second line
PI3K Mutation
28
(wujupxmnhs) = eyftvfysri ezdufsnhuu (bbobkkdvlx, 16 - 100)
Positive
15 Mar 2020
Phase 2
106
(200mg Abemaciclib)
tyyjfrkpqf(nxanchxuyz) = mbvpklrazs uvaoommiqu (juluipibje, mackulaxad - bqynssmnef)
-
25 Jun 2019
(150mg Abemaciclib + 150mg LY3023414)
tyyjfrkpqf(nxanchxuyz) = xtrtcefjng uvaoommiqu (juluipibje, nveuzeafoo - yreotamvaj)
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Approval

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Regulation

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