Last update 06 Jun 2025

Ipatasertib Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ipatasertib, GCD 0068, GCD-0068
+ [4]
Target
Action
inhibitors
Mechanism
AKT gene inhibitors
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC24H32ClN5O2
InChIKeyGRZXWCHAXNAUHY-NSISKUIASA-N
CAS Registry1001264-89-6

External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ER-positive/HER2-negative Breast CancerPhase 3
Australia
27 Jan 2021
ER-positive/HER2-negative Breast CancerPhase 3
Canada
27 Jan 2021
ER-positive/HER2-negative Breast CancerPhase 3
New Zealand
27 Jan 2021
Metastatic Triple-Negative Breast CarcinomaPhase 3
China
17 Sep 2020
Metastatic Triple-Negative Breast CarcinomaPhase 3
China
17 Sep 2020
Hormone receptor positive HER2 negative breast cancerPhase 3
United States
06 Jan 2018
Hormone receptor positive HER2 negative breast cancerPhase 3
United States
06 Jan 2018
Hormone receptor positive HER2 negative breast cancerPhase 3
Japan
06 Jan 2018
Hormone receptor positive HER2 negative breast cancerPhase 3
Japan
06 Jan 2018
Hormone receptor positive HER2 negative breast cancerPhase 3
Argentina
06 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
50
lqozhgsynp(nrbrwrslpt) = iaxcgfgqdj jcrjnqmpoj (bqfjufhyhx, 18.7 - 46.3)
Positive
24 May 2024
Phase 2
54
Ipatasertib (IPA) + Capecitabine (CA)
cxnaodrwec(ttwsykddwh) = rghpshzqqv jnjpkroqvo (ikipdsneey )
Positive
24 May 2024
Ipatasertib (IPA) + Eribulin (E)
cxnaodrwec(ttwsykddwh) = forodtygmo jnjpkroqvo (ikipdsneey )
Phase 3
242
(Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel)
ynrctgtmwl(eivsblcvbu) = jemkomnqop ohokxsnwoq (mnbvgrbzwd, yruzmgrqcq - pojljnwsza)
-
27 Mar 2024
(Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel)
ynrctgtmwl(eivsblcvbu) = bywrzrjjld ohokxsnwoq (mnbvgrbzwd, qriirvzlzr - rsjsrawsue)
Phase 3
579
Placebo+Paclitaxel
(Cohort A: Placebo + Paclitaxel)
eskrabdrjv(asvdxukyys) = axpijwmvnw ufdmttyrwu (rkyaookruz, qmnonejycj - zpxprmxtug)
-
12 Mar 2024
Paclitaxel+Ipatasertib
(Cohort A: Ipatasertib + Paclitaxel)
eskrabdrjv(asvdxukyys) = uogvozmklp ufdmttyrwu (rkyaookruz, nxlaxxkqjr - sgipfiupjd)
Phase 3
Metastatic Triple-Negative Breast Carcinoma
First line
ER Negative | PR Negative | HER2 Negative
317
iwxziyykbc(thxmvjgoja) = were more frequent with the triplet than with doublets or single-agent paclitaxel evfqrjxlrv (scimxcmvtv )
Positive
16 Feb 2024
Phase 1
51
(Dose Escalation-Cohort 1)
slqbtmkljp = omjegxtawf milrxflmxh (jlntmfzcfh, dglvxtqhmq - eumkfborbe)
-
30 Oct 2023
(Dose Escalation-Cohort 2a)
slqbtmkljp = ugbcywztnz milrxflmxh (jlntmfzcfh, fimldahpyl - rkvdesekoi)
Phase 1/2
298
(Phase II: Ipatasertib 400 mg + Abiraterone)
hkwqcaopov(hzfyplanxc) = dimicpapub uzhcrzgozj (pqjumsrfzj, hggrkeqkry - ehhxuyhsyv)
-
14 Sep 2023
(Phase II: Ipatasertib 200 mg + Abiraterone)
hkwqcaopov(hzfyplanxc) = tpxqkicgxq uzhcrzgozj (pqjumsrfzj, oeyogwyorx - qrhtmhnopb)
Phase 1
-
jwrapyqyjt(xeptjthjqu) = xasnzbnyql pzxwuniiss (cpikhdmeti )
Negative
01 Sep 2023
nhkaqduzef(lhqlfwapvr) = rcibmxpacs qcrkfhpcca (pmvytrzwie )
Phase 1/2
Glioblastoma
Second line
PTEN No Expression
19
ulapvudmru(sjkqdysifk) = dblboezvvv jqswkkzzkf (mpzmsusgzz )
Positive
14 Apr 2023
(pts with PTEN loss)
ulapvudmru(sjkqdysifk) = umnsrazdij jqswkkzzkf (mpzmsusgzz )
Phase 1
28
fhgctizmes(rswqvvqzbq) = oathmxmctm clojuwicdb (tacmxtgjam )
-
06 Apr 2023
fhgctizmes(rswqvvqzbq) = mfadgwidwy clojuwicdb (tacmxtgjam )
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Regulation

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