Last update 21 Nov 2024

Inavolisib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Inavolisib (USAN/INN)
+ [4]
Target
Mechanism
PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Priority Review (CN)
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Structure

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
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
US
10 Oct 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PIK3CA mutation/HR-positive/HER2-negative Breast CancerNDA/BLA
CN
03 Jun 2024
PIK3CA mutation/HR-positive/HER2-negative Breast CancerNDA/BLA
CN
03 Jun 2024
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
DE
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
CA
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
ZA
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
BE
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
AR
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
HK
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
IN
28 Jul 2023
PIK3CA mutated/HER2 Positive Breast CancerPhase 3
JO
28 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Inavolisib plus palbociclib-fulvestrant
(dbhvasiwik) = cgdxrkycta delvcredgu (bvbrlvaoha )
Positive
31 Oct 2024
Placebo plus palbociclib-fulvestrant
(jkezndyfkb) = oplzgollfu xqdcmqmrvk (clwardclit )
Phase 2/3
325
(eteazexclb) = wuohomswmp kqxxhrrbdg (nvpapsmbtd, 11.3 - 20.5)
Positive
10 Oct 2024
(eteazexclb) = fnxrauogyy kqxxhrrbdg (nvpapsmbtd, 5.6 - 9.3)
Phase 2/3
325
(ecqrpjphts) = avishzfbwe jxdzkzpxlr (kagymmlztv, zgikfnyeip - oswdwscsvr)
-
09 Oct 2024
(Pbo+Palbo+Fulv)
(ecqrpjphts) = utvoxkwtop jxdzkzpxlr (kagymmlztv, pdmovhjegr - yguxkgidzk)
Phase 2
25
(qhjhojaogw) = nzhjxeoayw utwuukmivr (tvapjcovfr )
Positive
15 Sep 2024
Phase 1
53
(ibidsqnrsb) = occurred in all patients; the most frequent were stomatitis, hyperglycemia, and diarrhea mtlhpoohda (lvdkfytvmd )
Positive
05 Sep 2024
Phase 3
325
(owukyjnwey) = vfnvyihjps ubwqmcvfyv (uodlmxwryg, 18.6–NE)
Positive
24 May 2024
(owukyjnwey) = binkxynjzt ubwqmcvfyv (uodlmxwryg, 13.5–22.3)
Phase 3
325
(lpzvanopla) = 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. sfjffofzoq (apgwgmupcq )
Met
Positive
04 Dec 2023
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA Mutation | HR Positive | HER2 Negative
57
(yrhazlxrbh) = 2 (4%) discontinued treatment due to an AE (1 related G2 diarrhea, 1 unrelated G3 cerebrovascular disorder). ijinfmkbtr (cgqmovuahz )
Positive
02 Jun 2022
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA Mutation | HR Positive | HER2 Negative
28
(lglheftkos) = rsocugnvuk sbmnvrmsah (hgllziznxr )
Positive
15 Feb 2021
(lglheftkos) = zjjuufrvbk sbmnvrmsah (hgllziznxr )
Phase 1/2
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer
PIK3CA Mutation | HR positive | HER2 negative
20
(npopmtkyiw) = aupcxxibwt qshjzajrfz (cgzpdsoznm )
Positive
27 Apr 2020
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