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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 M. tuberculosis, MRSA, E. coli and K. pneumoniae. 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 Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

    NCT06790693 · start 2025-04-09

    Registered record
    Registry ID
    NCT06790693
    Conditions
    Breast Cancer
    Interventions
    Inavolisib; Placebo; CDK4/6i; Letrozole
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2025-04-09
    Completion
    2032-02-01
    Enrolment
    450

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

    ConditionBreast Cancer
    InterventionInavolisib; Placebo; CDK4/6i; Letrozole
    PhasePhase 3
    Registry statusRecruiting

  • A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

    NCT05708235 · start 2024-04-01

    Registered record
    Registry ID
    NCT05708235
    Conditions
    Breast Cancer
    Interventions
    Giredestrant; Abemaciclib; Inavolisib; Standard ET followed by change in treatment
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-04-01
    Completion
    2028-06-30
    Enrolment
    976

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

    ConditionBreast Cancer
    InterventionGiredestrant; Abemaciclib; Inavolisib; Standard ET followed by change in treatment
    PhasePhase 2
    Registry statusRecruiting

  • A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers

    NCT06496568 · start 2023-12-11

    Registered record
    Registry ID
    NCT06496568
    Conditions
    PIK3CA-Mutated Cancers
    Interventions
    Inavolisib; Atezolizumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2023-12-11
    Completion
    2027-07-21
    Enrolment
    30

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

    ConditionPIK3CA-Mutated Cancers
    InterventionInavolisib; Atezolizumab
    PhasePhase 1
    Registry statusActive not recruiting

  • A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

    NCT05894239 · start 2023-09-08

    Registered record
    Registry ID
    NCT05894239
    Conditions
    Metastatic Breast Cancer
    Interventions
    Inavolisib; Phesgo; Placebo; Taxane-based Chemotherapy; Optional Endocrine Therapy of Investigator's Choice
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2023-09-08
    Completion
    2032-12-28
    Enrolment
    230

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

    ConditionMetastatic Breast Cancer
    InterventionInavolisib; Phesgo; Placebo; Taxane-based Chemotherapy +1 more
    PhasePhase 3
    Registry statusRecruiting

  • Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

    NCT05332561 · start 2023-06-29

    Registered record
    Registry ID
    NCT05332561
    Conditions
    Early-stage Breast Cancer
    Interventions
    Atezolizumab 1200 mg in 20 ML Injection; Inavolisib; Ipatasertib; Olaparib; Sacituzumab govitecan; Trastuzumab/pertuzumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-06-29
    Completion
    2030-12
    Enrolment
    240

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

    ConditionEarly-stage Breast Cancer
    InterventionAtezolizumab 1200 mg in 20 ML Injection; Inavolisib; Ipatasertib; Olaparib +2 more
    PhasePhase 2
    Registry statusRecruiting

  • A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

    NCT05646862 · start 2023-06-07

    Registered record
    Registry ID
    NCT05646862
    Conditions
    Breast Cancer
    Interventions
    Inavolisib; Fulvestrant; Alpelisib; Bupropion; Omeprazole; Midazolam
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2023-06-07
    Completion
    2029-03-30
    Enrolment
    420

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

    ConditionBreast Cancer
    InterventionInavolisib; Fulvestrant; Alpelisib; Bupropion +2 more
    PhasePhase 3
    Registry statusRecruiting

  • A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

    NCT05862285 · start 2023-06-01

    Registered record
    Registry ID
    NCT05862285
    Conditions
    Cancer
    Interventions
    Ipatasertib; Tiragolumab; Atezolizumab; Tiragolumab and Atezolizumab; Bevacizumab; Entrectinib; Inavolisib; Divarasib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2023-06-01
    Completion
    2033-03-01
    Enrolment
    100

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

    ConditionCancer
    InterventionIpatasertib; Tiragolumab; Atezolizumab; Tiragolumab and Atezolizumab +4 more
    PhasePhase 3
    Registry statusRecruiting

  • First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

    NCT05768139 · start 2023-04-17

    Registered record
    Registry ID
    NCT05768139
    Conditions
    Breast Cancer; Solid Tumors, Adult
    Interventions
    STX-478; Fulvestrant; Ribociclib; Palbociclib; Letrozole; Anastrozole; Exemestane; Tamoxifen; Abemaciclib; Imlunestrant; Metformin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2023-04-17
    Completion
    2030-07
    Enrolment
    880

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

    ConditionBreast Cancer; Solid Tumors, Adult
    InterventionSTX-478; Fulvestrant; Ribociclib; Palbociclib +7 more
    PhasePhase 1 / Phase 2
    Registry statusRecruiting

  • Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

    NCT05306041 · start 2023-01-02

    Registered record
    Registry ID
    NCT05306041
    Conditions
    HER2-positive Breast Cancer
    Interventions
    Inavolisib; PHESGO; Endocrine therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-01-02
    Completion
    2027-03
    Enrolment
    170

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

    ConditionHER2-positive Breast Cancer
    InterventionInavolisib; PHESGO; Endocrine therapy
    PhasePhase 2
    Registry statusRecruiting

  • A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

    NCT04929223 · start 2021-10-22

    Registered record
    Registry ID
    NCT04929223
    Conditions
    Metastatic Colorectal Cancer
    Interventions
    Inavolisib; Bevacizumab; Cetuximab; Atezolizumab; Tiragolumab; SY-5609; Divarasib; FOLFOX; FOLFIRI; FoundationOne®Liquid CDx
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2021-10-22
    Completion
    2030-08-31
    Enrolment
    542

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

    ConditionMetastatic Colorectal Cancer
    InterventionInavolisib; Bevacizumab; Cetuximab; Atezolizumab +6 more
    PhasePhase 1
    Registry statusRecruiting

  • A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

    NCT04486352 · start 2021-10-20

    Registered record
    Registry ID
    NCT04486352
    Conditions
    Endometrial Cancer
    Interventions
    Atezolizumab - 28 Day Cycle; Bevacizumab; Ipatasertib; Talazoparib; Trastuzumab emtansine; Tiragolumab; Atezolizumab - 21 Day Cycle; Inavolisib; Letrozole; Giredestrant; Abemaciclib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2021-10-20
    Completion
    2027-10
    Enrolment
    148

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

    ConditionEndometrial Cancer
    InterventionAtezolizumab - 28 Day Cycle; Bevacizumab; Ipatasertib; Talazoparib +7 more
    PhasePhase 1 / Phase 2
    Registry statusRecruiting

  • CRAFT: The NCT-PMO-1602 Phase II Trial

    NCT04551521 · start 2021-10-13

    Registered record
    Registry ID
    NCT04551521
    Conditions
    Metastatic or Locally Advanced Malignancies
    Interventions
    Vemurafenib; Cobimetinib; Atezolizumab; Trastuzumab; Pertuzumab; Alectinib; Ipatasertib; Atezolizumab; Atezolizumab; Atezolizumab; Inavolisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2021-10-13
    Completion
    2024-12-30
    Enrolment
    72

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

    ConditionMetastatic or Locally Advanced Malignancies
    InterventionVemurafenib; Cobimetinib; Atezolizumab; Trastuzumab +7 more
    PhasePhase 2
    Registry statusCompleted

  • A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

    NCT04931342 · start 2021-10-07

    Registered record
    Registry ID
    NCT04931342
    Conditions
    Ovarian Cancer
    Interventions
    Ipatasertib; Cobimetinib; Trastuzumab Emtansine; Atezolizumab; Bevacizumab; Paclitaxel; Giredestrant; Abemaciclib; Inavolisib; Palbociclib; Letrozole; Olaparib; Luteinizing Hormone-Releasing Hormone (LHRH) Agonists; Cyclophosphamide; Inavolisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2021-10-07
    Completion
    2028-05-30
    Enrolment
    176

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

    ConditionOvarian Cancer
    InterventionIpatasertib; Cobimetinib; Trastuzumab Emtansine; Atezolizumab +11 more
    PhasePhase 2
    Registry statusActive not recruiting

  • Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer

    NCT04849364 · start 2021-08-24

    Registered record
    Registry ID
    NCT04849364
    Conditions
    Breast Cancer; Triple Negative Breast Cancer
    Interventions
    Capecitabine; Talazoparib; Pembrolizumab; Inavolisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2021-08-24
    Completion
    2024-12-02
    Enrolment
    52

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

    ConditionBreast Cancer; Triple Negative Breast Cancer
    InterventionCapecitabine; Talazoparib; Pembrolizumab; Inavolisib
    PhasePhase 2
    Registry statusTerminated

  • A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

    NCT04802759 · start 2021-06-22

    Registered record
    Registry ID
    NCT04802759
    Conditions
    Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
    Interventions
    Giredestrant; Abemaciclib; Ipatasertib; Inavolisib; Ribociclib; Everolimus; Samuraciclib; PH FDC SC; Palbociclib; Atezolizumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2021-06-22
    Completion
    2029-05-30
    Enrolment
    316

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

    ConditionInoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
    InterventionGiredestrant; Abemaciclib; Ipatasertib; Inavolisib +6 more
    PhasePhase 1 / Phase 2
    Registry statusRecruiting