Last update 08 May 2025

Gedatolisib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Gedatolisib (USAN/INN)
+ [2]
Action
inhibitors
Mechanism
PI3K family inhibitors(Phosphatidylinositol 3-kinase family inhibitors), mTOR inhibitors(Serine/threonine-protein kinase mTOR inhibitors)
Originator Organization
Active Organization
Inactive Organization-
License Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (United States), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC32H41N9O4
InChIKeyDWZAEMINVBZMHQ-UHFFFAOYSA-N
CAS Registry1197160-78-3

External Link

KEGGWikiATCDrug Bank
D10635Gedatolisib-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancerPhase 3
United States
23 Mar 2022
RAS Wild Type Colorectal CancerDiscovery
Spain
15 Nov 2013
Recurrent Endometrial CancerDiscovery
Japan
19 Jan 2012
Recurrent Endometrial CancerDiscovery
Australia
19 Jan 2012
Recurrent Endometrial CancerDiscovery
United States
19 Jan 2012
Recurrent Endometrial CancerDiscovery
Russia
19 Jan 2012
Recurrent Endometrial CancerDiscovery
Spain
19 Jan 2012
Recurrent Endometrial CancerDiscovery
United Kingdom
19 Jan 2012
Recurrent Endometrial CancerDiscovery
Poland
19 Jan 2012
Recurrent Endometrial CancerDiscovery
Canada
19 Jan 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Gedatolisib + CDK4/6 inhibitor + Fulvestrant
(lggsivbpuv) = expected mPFS is 25 to 28 months neabskbija (nuedquhvzf )
Positive
29 Apr 2025
Phase 1
138
(fcxdypmujb) = pgyljtcufr rmptzjnccj (gigfjhfvmz )
Positive
12 May 2023
Phase 3
-
(jzrrusernf) = hiepnlfbnq ujyrndfbfs (alqasuwrnt )
Positive
01 Mar 2023
Phase 1
Hormone receptor positive breast cancer
First line
PIK3CA mutation status
103
Gedatolisib+Palbociclib+Fulvestrant (Prior CDK4/6i)
(nfezklscsj) = fzdbugwhky qcqiksekbu (nycthzeggo )
Positive
01 Mar 2023
Phase 1/2
Germline BRCA-mutated, HER2-negative metastatic breast cancer | Triple Negative Breast Cancer
Second line
BRCA1 Mutation | HER2 Negative | ER Negative ...
14
(zqnzdcgrxb) = The MTD of gedatolisib was 180 mg and MTD of talazoparib was 1 mg. wxcgtimrwk (rdmwwwybxw )
Positive
02 Jun 2022
(patients with a BRCA 1 or 2 mutation)
Phase 1
Estrogen receptor positive breast cancer
First line
ER+ | HER2-negative
103
(osbktiubxq) = lpddojccdy vblhpmpfuh (vmnroqpppq )
Positive
15 Feb 2022
(osbktiubxq) = gxdmxeowgg vblhpmpfuh (vmnroqpppq )
Phase 1
Solid tumor
First line
17
(togxtwcllu) = neutropenia (35%), anemia (18%), and mucositis (12%) vkqlymgzgm (wpkltshowy )
Positive
15 Sep 2021
Phase 1
18
Gedatolisib + Cofetuzumab Pelidotin 110mg+1.4mg/kg
(fggvcaubjn) = yozfipafpc vpkrwtgscy (spzbbpdjfw )
Positive
15 Feb 2021
Phase 2
12
junkyymfnc(tfrddfkufw) = Treatment-related G3 adverse events (hypertension, hypoalbuminemia, oral mucositis, ALT increased and creatinine increased) were observed in 4 pts wljoijiliy (ztvdevynxu )
Negative
25 May 2020
Phase 1
-
6
qoelpgcjez(lyfjfynjlm) = rhxjlieyjs rdplcbddlr (qfnhnqcqww )
-
01 Jan 2019
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