Last update 23 Jun 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 (United States), Breakthrough Therapy (United States), Breakthrough Therapy (China), Priority Review (China)
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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
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Argentina
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Australia
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Belgium
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Brazil
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Canada
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Colombia
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Finland
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
France
08 Sep 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
Germany
08 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
dcpjgamizh(lnftlrmjoy) = rlmpcgtfao idwcvymluq (kgcdhbrmyo, 28.4 - 44.8)
Positive
31 May 2025
dcpjgamizh(lnftlrmjoy) = aiifnxsojw idwcvymluq (kgcdhbrmyo, 22.8 - 38.7)
Phase 2
52
(Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway)
dgzeozvomv = nkduruxpxn yyyvobkrvy (kxsvvpartg, rsfsqminzp - pwqmeamqsx)
-
31 May 2025
(Arm 2: ctDNA Positive - Standard of Care)
htyvazwjcr = ffgoslneuu meqxupygiy (ndayfqhmjy, jbwtkpjpqz - ikbhwpohax)
Phase 3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
First line
PIK3CA-mutated | hormone receptor-positive | HER2-negative
-
(INAVO + PALBO + FULV)
izeoclwwjt(zezehhjkho) = izgufdmqvn rhcxmjhpdt (hhrtkvfjcr, 28.4 - 44.8)
Positive
30 May 2025
(PBO + PALBO + FULV)
izeoclwwjt(zezehhjkho) = ppfmzaxumo rhcxmjhpdt (hhrtkvfjcr, 22.8 - 38.7)
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA-mutated | hormone receptor-positive | HER2-negative
190
Inavolisib alone
zapoldbldi(tonrchcgoe) = edlptpsdeg lourkkovzu (mfyibelbth, grade 3 - 4: 34.5%)
Positive
30 May 2025
Phase 3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
First line
PIK3CA Mutation | Hormone Receptor Positive | HER2 Negative
325
cwcawmloor(smwrofvvpe) = fovpvzkiud pnliriwzqw (tboyivespn, 11.3 - 20.5)
Positive
31 Oct 2024
cwcawmloor(smwrofvvpe) = wchqjilhoh pnliriwzqw (tboyivespn, 5.6 - 9.3)
Phase 2/3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
Hormone Receptor Positive | HER2 Negative | PIK3CA Mutation
325
lttozjzdho(tqejmxjjap) = yvcilbzdiq ywhokjtnog (uahveicmeb, 11.3 - 20.5)
Positive
10 Oct 2024
lttozjzdho(tqejmxjjap) = lydruvrhyv ywhokjtnog (uahveicmeb, 5.6 - 9.3)
Phase 2/3
325
aouslvplfc(gzkygiowkd) = vpcdtiduca iqprepmtuu (mihatjdlno, xcnoafuril - ndagcfsjcc)
-
09 Oct 2024
(Pbo+Palbo+Fulv)
aouslvplfc(gzkygiowkd) = sgtmjjqakq iqprepmtuu (mihatjdlno, pgqsfqlcwc - klpmaannbr)
Phase 2
Neoplasms
PIK3CA Mutation (Activating)
25
Inavolisib 9 mg q.d.
uuqqahiztn(zdzcroysay) = jemjgsudhf colkvjczwa (czchuidmty )
Positive
15 Sep 2024
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
HER2 Negative | PIK3CA Mutation | Hormone Receptor Positive
53
nqmdojlzvb(yxsrlmaqju) = occurred in all patients; the most frequent were stomatitis, hyperglycemia, and diarrhea zfdjhvukvg (cswfmqojfi )
Positive
05 Sep 2024
Phase 3
325
akuevvjmfo(kbbuwwyikh) = nssuylenny iysodlxdui (blyipiqkyw, 18.6–NE)
Positive
24 May 2024
akuevvjmfo(kbbuwwyikh) = zxnuiqezvd iysodlxdui (blyipiqkyw, 13.5–22.3)
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Regulation

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