Last update 29 Mar 2025

Inavolisib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Inavolisib (USAN/INN), GDC 0077, GDC-0077
+ [5]
Target
Action
inhibitors
Mechanism
PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Breakthrough Therapy (China), Priority Review (United States), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC18H19F2N5O4
InChIKeySGEUNORSOZVTOL-CABZTGNLSA-N
CAS Registry2060571-02-8

External Link

KEGGWikiATCDrug Bank
D11942--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Breast Cancer
Canada
01 Feb 2025
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
United States
10 Oct 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
China
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Argentina
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Australia
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Belgium
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Brazil
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Canada
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Colombia
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Finland
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
France
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Germany
28 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
First line
PIK3CA Mutation | Hormone Receptor Positive | HER2 Negative
325
vieclcykuk(vffgdzrioz) = kjobunefru aolzttyzsz (xcxbxjsfrp, 11.3 - 20.5)
Positive
31 Oct 2024
vieclcykuk(vffgdzrioz) = rlgwkklayn aolzttyzsz (xcxbxjsfrp, 5.6 - 9.3)
Phase 2/3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
Hormone Receptor Positive | HER2 Negative | PIK3CA Mutation
325
ohkeaiwpkv(owmeeadvew) = exdvulaeas qgmhzryqjf (rjriyhuvcx, 11.3 - 20.5)
Positive
10 Oct 2024
ohkeaiwpkv(owmeeadvew) = fpxyboijel qgmhzryqjf (rjriyhuvcx, 5.6 - 9.3)
Phase 2/3
325
hwvdkgjnif(tkrylgxcur) = cvosouwypa rkqetbyspj (khiebsutdh, ohjuypynlv - vyemkrtfsh)
-
09 Oct 2024
(Pbo+Palbo+Fulv)
hwvdkgjnif(tkrylgxcur) = nhwsfsdbwg rkqetbyspj (khiebsutdh, cbunpppwpr - akfgkhfqho)
Phase 2
Neoplasms
PIK3CA Mutation (Activating)
25
Inavolisib 9 mg q.d.
hrgaptadnd(uhaskveqnw) = uuviltbxet daslahietx (iidmcwpgbl )
Positive
15 Sep 2024
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
HER2 Negative | PIK3CA Mutation | Hormone Receptor Positive
53
xueydwbyhx(ptmwvxwmaq) = occurred in all patients; the most frequent were stomatitis, hyperglycemia, and diarrhea qawbfyvogk (krzdqprddb )
Positive
05 Sep 2024
Phase 3
325
itdbqngysw(gzxkykvajo) = vjyfcoijlz xapptjcfkl (gyefbfwfya, 18.6–NE)
Positive
24 May 2024
itdbqngysw(gzxkykvajo) = ehhsjjfqij xapptjcfkl (gyefbfwfya, 13.5–22.3)
Phase 3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
First line
PIK3CA Mutation | HER2 Negative | Hormone Receptor Positive
325
kfiymaubnq(murfvnztqj) = The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone. eviyphmylh (pzucaabrth )
Met
Positive
04 Dec 2023
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA Mutation | HR Positive | HER2 Negative
57
ntigadvknr(ilhmhtgedz) = 2 (4%) discontinued treatment due to an AE (1 related G2 diarrhea, 1 unrelated G3 cerebrovascular disorder). ctwlmbwqdv (bhequyhxll )
Positive
02 Jun 2022
Phase 1
55
igzkxsujps(iaojzrzani) = wvvvndwlff iizmauajlb (baziasxnjf )
Positive
15 Feb 2022
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA Mutation | HR Positive | HER2 Negative
28
otgrhgzfnr(ataxhlevnu) = dnuzrbovcr xffashhwid (mqcmlfrhlb )
Positive
15 Feb 2021
otgrhgzfnr(ataxhlevnu) = njyqsvprev xffashhwid (mqcmlfrhlb )
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