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AMR Drug RepurposingSmart Screeningresearch prototype

Inavolisib

FDA-approved product (tablet, oral), marketed as Itovebi.

Registered studies
36
Lab records
0
Pathogens at ≥40%
4 of 4

Chemical structure

Chemical structure of Inavolisib
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Breast cancer
  • Breast neoplasm

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

FDA pharmacologic class
Kinase Inhibitor FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against E. coli, MRSA, K. pneumoniae and M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA51.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli43.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae41.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis57.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

36registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Open Inavolisib in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-6.1 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-6.9 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-6.9 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.0 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Inavolisib with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes

    NCT07748208 · start 2026-10-30

    Registered record
    Registry ID
    NCT07748208
    Conditions
    Breast Cancer; Diabetes Type II
    Interventions
    Inavolisib; Fulvestrant; Palbociclib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-10-30
    Completion
    2029-09-30
    Enrolment
    40

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer; Diabetes Type II
    InterventionInavolisib; Fulvestrant; Palbociclib
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients

    NCT07694973 · start 2026-08-29

    Registered record
    Registry ID
    NCT07694973
    Conditions
    Pancreatic Ductal Adenocarcinoma (PDAC)
    Interventions
    Inavolisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-08-29
    Completion
    2028-07-29
    Enrolment
    62

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPancreatic Ductal Adenocarcinoma (PDAC)
    InterventionInavolisib
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

    NCT07618390 · start 2026-06

    Registered record
    Registry ID
    NCT07618390
    Conditions
    Breast Cancer
    Interventions
    Inavolisib + Ribociclib + Fulvestrant
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-06
    Completion
    2028-12
    Enrolment
    160

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer
    InterventionInavolisib + Ribociclib + Fulvestrant
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer

    NCT07543250 · start 2026-05-16

    Registered record
    Registry ID
    NCT07543250
    Conditions
    Breast Cancer
    Interventions
    Inavolisib in Combination With ET; Inavolisib in Combination With ET+CDK4/6i
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2026-05-16
    Completion
    2027-07-30
    Enrolment
    100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer
    InterventionInavolisib in Combination With ET; Inavolisib in Combination With ET+CDK4/6i
    PhaseNot recorded
    Registry statusNot yet recruiting

  • Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4

    NCT07522697 · start 2026-05

    Registered record
    Registry ID
    NCT07522697
    Conditions
    Endometrial Cancer
    Interventions
    Inavolisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-05
    Completion
    2030-05
    Enrolment
    48

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionEndometrial Cancer
    InterventionInavolisib
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

    NCT07405801 · start 2026-04-07

    Registered record
    Registry ID
    NCT07405801
    Conditions
    Breast Cancer
    Interventions
    Inavolisib; Ribociclib; Fulvestrant; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-04-07
    Completion
    2030-02-26
    Enrolment
    80

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer
    InterventionInavolisib; Ribociclib; Fulvestrant; Placebo
    PhasePhase 2
    Registry statusRecruiting

  • Risk-Stratified Management of Inavolisib-Induced Hyperglycemia and Patient Adherence

    NCT07817056 · start 2026-04-01

    Registered record
    Registry ID
    NCT07817056
    Conditions
    Breast Cancer; Hyperglycemia
    Interventions
    Risk-stratified hyperglycemia management strategy
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2026-04-01
    Completion
    2028-10-31
    Enrolment
    100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer; Hyperglycemia
    InterventionRisk-stratified hyperglycemia management strategy
    PhaseNot recorded
    Registry statusRecruiting

  • A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation

    NCT07441512 · start 2026-03-15

    Registered record
    Registry ID
    NCT07441512
    Conditions
    TNBC - Triple-Negative Breast Cancer; TNBC
    Interventions
    Inavolisib in Combination With Eribulin
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-03-15
    Completion
    2028-03-15
    Enrolment
    26

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionTNBC - Triple-Negative Breast Cancer; TNBC
    InterventionInavolisib in Combination With Eribulin
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer

    NCT07287150 · start 2026-03-11

    Registered record
    Registry ID
    NCT07287150
    Conditions
    Metastatic Castration-Resistant Prostate Cancer
    Interventions
    Inavolisib; Enzalutamide; Abiraterone; Docetaxel
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-03-11
    Completion
    2029-07-30
    Enrolment
    100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Castration-Resistant Prostate Cancer
    InterventionInavolisib; Enzalutamide; Abiraterone; Docetaxel
    PhasePhase 2
    Registry statusRecruiting

  • To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

    NCT07368998 · start 2026-02-18

    Registered record
    Registry ID
    NCT07368998
    Conditions
    Breast Cancer
    Interventions
    Inavolisib; Fulvestrant
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-02-18
    Completion
    2031-10-31
    Enrolment
    80

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer
    InterventionInavolisib; Fulvestrant
    PhasePhase 2
    Registry statusRecruiting

  • A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer

    NCT07323576 · start 2026-02-01

    Registered record
    Registry ID
    NCT07323576
    Conditions
    Colorectal Cancer
    Interventions
    Inavolisib; Bevacizumab; FOLFOX; FOLFIRI; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2026-02-01
    Completion
    2031-03-31
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionColorectal Cancer
    InterventionInavolisib; Bevacizumab; FOLFOX; FOLFIRI +1 more
    PhasePhase 2
    Registry statusWithdrawn

  • A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

    NCT07347600 · start 2026-01-21

    Registered record
    Registry ID
    NCT07347600
    Conditions
    Locally Advanced Breast Cancer; Metastatic Breast Cancer
    Interventions
    Inavolisib; Palbociclib; Fulvestrant
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2026-01-21
    Completion
    2029-12-31
    Enrolment
    500

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionLocally Advanced Breast Cancer; Metastatic Breast Cancer
    InterventionInavolisib; Palbociclib; Fulvestrant
    PhaseNot recorded
    Registry statusRecruiting

  • A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC

    NCT07245797 · start 2025-12-15

    Registered record
    Registry ID
    NCT07245797
    Conditions
    Breast Cancer
    Interventions
    fixed-dose combination of pertuzumab and trastuzumab as subcutaneousformulation q3w and nab-paclitaxel in 3-week cycle for total 6 cycles with inavolisib (6 cycles) or without inavolisib.
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2025-12-15
    Completion
    2027-02-23
    Enrolment
    164

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer
    Interventionfixed-dose combination of pertuzumab and trastuzumab as subcutaneousformulation q3w and nab-paclitaxel in 3-week cycle for total 6 cycles with inavolisib (6 cycles) or without inavolisib.
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

    NCT07054190 · start 2025-09-09

    Registered record
    Registry ID
    NCT07054190
    Conditions
    Breast Cancer
    Interventions
    Inavolisib; Ribociclib; Letrozole; Giredestrant
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-09-09
    Completion
    2027-09-28
    Enrolment
    120

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer
    InterventionInavolisib; Ribociclib; Letrozole; Giredestrant
    PhasePhase 2
    Registry statusRecruiting

  • A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib

    NCT07144111 · start 2025-08-21

    Registered record
    Registry ID
    NCT07144111
    Conditions
    Hepatic Impairment
    Interventions
    Inavolisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2025-08-21
    Completion
    2026-11-16
    Enrolment
    32

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHepatic Impairment
    InterventionInavolisib
    PhasePhase 1
    Registry statusRecruiting