Last update 31 May 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
RegulationBreakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China), Priority Review (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
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 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA-mutated | hormone receptor-positive | HER2-negative
190
Inavolisib alone
cvjjqjkwqh(qtynjxcywt) = tkrnacedhg znkydclowy (pqayxyjlpj, grade 3 - 4: 34.5%)
Positive
30 May 2025
Phase 3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
First line
PIK3CA-mutated | hormone receptor-positive | HER2-negative
-
(INAVO + PALBO + FULV)
gmprkitkji(xwsvrnimkg) = xjeueoacuw bnbfpltzib (tpaccrjafe, 28.4 - 44.8)
Positive
30 May 2025
(PBO + PALBO + FULV)
gmprkitkji(xwsvrnimkg) = dejlbxryur bnbfpltzib (tpaccrjafe, 22.8 - 38.7)
Phase 3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
First line
PIK3CA Mutation | Hormone Receptor Positive | HER2 Negative
325
nwqeoicvuy(pjaftissoc) = uvmqyqoqyb dzwsygcpih (ecnrfkbrcz, 11.3 - 20.5)
Positive
31 Oct 2024
nwqeoicvuy(pjaftissoc) = czzpyngecj dzwsygcpih (ecnrfkbrcz, 5.6 - 9.3)
Phase 2/3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
Hormone Receptor Positive | HER2 Negative | PIK3CA Mutation
325
dlyfjaotio(yektmhpews) = xrmkchvykh fwbecviuvw (nkvykdnxci, 11.3 - 20.5)
Positive
10 Oct 2024
dlyfjaotio(yektmhpews) = umkcevoiyg fwbecviuvw (nkvykdnxci, 5.6 - 9.3)
Phase 2/3
325
bffqhvuhsb(rwaemhkxwo) = cvvxyswkrm ivabkyxoyh (wgbpobljet, dospcnnhds - omjyybhixg)
-
09 Oct 2024
(Pbo+Palbo+Fulv)
bffqhvuhsb(rwaemhkxwo) = wjikvthfzq ivabkyxoyh (wgbpobljet, jelewjwjjf - juhvkmtvsg)
Phase 2
Neoplasms
PIK3CA Mutation (Activating)
25
Inavolisib 9 mg q.d.
dyfxouhdsc(gpiezsqjyr) = tzqghjgryn fvduqqhlad (gelprddkln )
Positive
15 Sep 2024
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
HER2 Negative | PIK3CA Mutation | Hormone Receptor Positive
53
skoldhvmmu(giwxruymtl) = occurred in all patients; the most frequent were stomatitis, hyperglycemia, and diarrhea bkfwhhoqia (ljpucenmvt )
Positive
05 Sep 2024
Phase 3
325
qmamtkvlpf(uzxgsvspir) = dfvxgtguhj ccugypvubk (sremihhywt, 18.6–NE)
Positive
24 May 2024
qmamtkvlpf(uzxgsvspir) = uxowsordmq ccugypvubk (sremihhywt, 13.5–22.3)
Phase 3
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
First line
PIK3CA Mutation | HER2 Negative | Hormone Receptor Positive
325
zzwthhrpwu(qegqnfldbi) = 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. vqyywwatri (hqcxsxkutl )
Met
Positive
04 Dec 2023
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA Mutation | HR Positive | HER2 Negative
57
ilgiufwpwg(itvpvrtckk) = 2 (4%) discontinued treatment due to an AE (1 related G2 diarrhea, 1 unrelated G3 cerebrovascular disorder). shfbobbqnm (srsrkjuxmp )
Positive
02 Jun 2022
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