Skip to content
AMR Drug RepurposingSmart Screeningresearch prototype

Alpelisib

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

Registered studies
50+
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Breast cancer
  • Breast carcinoma
  • Breast neoplasm
  • Cancer
  • Neoplasm

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

WHO therapeutic group
Phosphatidylinositol-3-kinase (pi3k) inhibitors
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA, E. coli 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
  • MRSA63.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli40.5% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae25.8% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis58.0% 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

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

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

Open Alpelisib in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.9 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.9 kcal/mol

0better fit →-12

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

-8.2 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.8 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 Alpelisib 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.

  • Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study

    NCT05294289 · start 2022-05-16

    Registered record
    Registry ID
    NCT05294289
    Conditions
    PIK3CA-related Overgrowth Spectrum
    Interventions
    Alpelisib
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-05-16
    Completion
    2024-06-28
    Enrolment
    77

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

    ConditionPIK3CA-related Overgrowth Spectrum
    InterventionAlpelisib
    PhaseNot recorded
    Registry statusCompleted

  • A Descriptive Study of Baseline Characteristics, Clinical Outcomes, and Treatment Patterns of HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Alpelisib Plus Fulvestrant Who Have Received Fulvestrant in Any Prior Line of Therapy

    NCT05853432 · start 2022-03-16

    Registered record
    Registry ID
    NCT05853432
    Conditions
    HR+/HER2- Advanced or Metastatic Breast Cancer
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-03-16
    Completion
    2022-05-02
    Enrolment
    157

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

    ConditionHR+/HER2- Advanced or Metastatic Breast Cancer
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted

  • Survey Among Healthcare Professionals Treating Patients With Metastatic Breast Cancer in Selected European Countries to Evaluate Their Knowledge on Management of Hyperglycemia When Using Alpelisib

    NCT05073120 · start 2022-02-28

    Registered record
    Registry ID
    NCT05073120
    Conditions
    Breast Cancer
    Interventions
    Piqray Prescriber's/HCP guide for hyperglycemia
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-02-28
    Completion
    2024-06-05
    Enrolment
    103

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

    ConditionBreast Cancer
    InterventionPiqray Prescriber's/HCP guide for hyperglycemia
    PhaseNot recorded
    Registry statusCompleted

  • First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies

    NCT05627960 · start 2022-02-14

    Registered record
    Registry ID
    NCT05627960
    Conditions
    Triple Negative Breast Cancer; Hormone-Resistant Breast Cancer; Non Small Cell Lung Cancer; Mesothelioma
    Interventions
    AG-01 Compound
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2022-02-14
    Completion
    2026-11
    Enrolment
    77

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

    ConditionTriple Negative Breast Cancer; Hormone-Resistant Breast Cancer; Non Small Cell Lung Cancer; Mesothelioma
    InterventionAG-01 Compound
    PhasePhase 1
    Registry statusRecruiting

  • Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

    NCT04997902 · start 2021-12-07

    Registered record
    Registry ID
    NCT04997902
    Conditions
    HNSCC
    Interventions
    Tipifarnib; Alpelisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2021-12-07
    Completion
    2025-08-29
    Enrolment
    45

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

    ConditionHNSCC
    InterventionTipifarnib; Alpelisib
    PhasePhase 1 / Phase 2
    Registry statusCompleted

  • Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

    NCT05107388 · start 2021-12

    Registered record
    Registry ID
    NCT05107388
    Conditions
    Breast Cancer; Diabetes
    Interventions
    FreeStyle Libre Pro
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2021-12
    Completion
    2024-03
    Enrolment
    40

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

    ConditionBreast Cancer; Diabetes
    InterventionFreeStyle Libre Pro
    PhaseNot applicable
    Registry statusUnknown

  • Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world

    NCT05022342 · start 2021-10-27

    Registered record
    Registry ID
    NCT05022342
    Conditions
    Breast Cancer
    Interventions
    alpelisib plus fulvestrant
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2021-10-27
    Completion
    2025-02-11
    Enrolment
    595

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

    ConditionBreast Cancer
    Interventionalpelisib plus fulvestrant
    PhaseNot recorded
    Registry statusCompleted

  • Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

    NCT05090358 · start 2021-10-08

    Registered record
    Registry ID
    NCT05090358
    Conditions
    Breast Cancer; Breast Cancer Stage IV; Metastatic Breast Cancer
    Interventions
    Ketogenic Diet; Low Carbohydrate Diet; Alpelisib; Fulvestrant; Canagliflozin
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2021-10-08
    Completion
    2027-10-08
    Enrolment
    15

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

    ConditionBreast Cancer; Breast Cancer Stage IV; Metastatic Breast Cancer
    InterventionKetogenic Diet; Low Carbohydrate Diet; Alpelisib; Fulvestrant +1 more
    PhasePhase 2
    Registry statusActive not recruiting

  • Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

    NCT05063786 · start 2021-09-14

    Registered record
    Registry ID
    NCT05063786
    Conditions
    Advanced Breast Cancer
    Interventions
    Trastuzumab; Alpelisib; Fulvestrant; Vinorelbine; Capecitabine; Eribulin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2021-09-14
    Completion
    2026-06
    Enrolment
    27

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

    ConditionAdvanced Breast Cancer
    InterventionTrastuzumab; Alpelisib; Fulvestrant; Vinorelbine +2 more
    PhasePhase 3
    Registry statusActive not recruiting

  • A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib

    NCT06705504 · start 2021-06-11

    Registered record
    Registry ID
    NCT06705504
    Conditions
    Hormone Receptor Positive HER-2 Negative Breast Cancer
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2021-06-11
    Completion
    2023-11-30
    Enrolment
    435

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

    ConditionHormone Receptor Positive HER-2 Negative Breast Cancer
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted

  • Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

    NCT04762979 · start 2021-02-12

    Registered record
    Registry ID
    NCT04762979
    Conditions
    Hormone Receptor Positive Breast Carcinoma; HER2-negative Breast Cancer; PIK3CA Mutant Metastatic Breast Cancer
    Interventions
    Alpelisib; Fulvestrant; Aromatase inhibitor
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2021-02-12
    Completion
    2026-05
    Enrolment
    44

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

    ConditionHormone Receptor Positive Breast Carcinoma; HER2-negative Breast Cancer; PIK3CA Mutant Metastatic Breast Cancer
    InterventionAlpelisib; Fulvestrant; Aromatase inhibitor
    PhasePhase 2
    Registry statusActive not recruiting

  • Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib

    NCT04285723 · start 2020-06-09

    Registered record
    Registry ID
    NCT04285723
    Conditions
    PIK3CA-Related Overgrowth Spectrum (PROS)
    Interventions
    alpelisib
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2020-06-09
    Completion
    2021-04-16
    Enrolment
    57

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

    ConditionPIK3CA-Related Overgrowth Spectrum (PROS)
    Interventionalpelisib
    PhaseNot recorded
    Registry statusCompleted

  • Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer

    NCT03601507 · start 2019-03-11

    Registered record
    Registry ID
    NCT03601507
    Conditions
    CDKN2A-p16 Positive; HPV Positive Oropharyngeal Squamous Cell Carcinoma; Stage I Oropharyngeal Squamous Cell Carcinoma AJCC V7; Stage II Oropharyngeal Squamous Cell Carcinoma AJCC V7; Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7; Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
    Interventions
    Alpelisib; Laboratory Biomarker Analysis; Pharmacodynamic Study; Therapeutic Conventional Surgery
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2019-03-11
    Completion
    2022-05-24
    Enrolment
    9

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

    ConditionCDKN2A-p16 Positive; HPV Positive Oropharyngeal Squamous Cell Carcinoma; Stage I Oropharyngeal Squamous Cell Carcinoma AJCC V7; Stage II Oropharyngeal Squamous Cell Carcinoma AJCC V7 +2 more
    InterventionAlpelisib; Laboratory Biomarker Analysis; Pharmacodynamic Study; Therapeutic Conventional Surgery
    PhasePhase 2
    Registry statusTerminated

  • SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer

    NCT03386162 · start 2018-03-15

    Registered record
    Registry ID
    NCT03386162
    Conditions
    Breast Cancer, PI3K, Alpelisib
    Interventions
    Alpelisib; Chemotherapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2018-03-15
    Completion
    2022-11-18
    Enrolment
    31

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

    ConditionBreast Cancer, PI3K, Alpelisib
    InterventionAlpelisib; Chemotherapy
    PhasePhase 2
    Registry statusTerminated

  • A Window of Opportunity Study to Assess the Modulation of Biomarkers in Head and Neck Squamous Cell Cancer (HNSCC) By Preoperative Treatment With BYL719

    NCT03138070 · start 2017-10-20

    Registered record
    Registry ID
    NCT03138070
    Conditions
    Head and Neck Squamous Cell Cancer
    Interventions
    BYL719
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2017-10-20
    Completion
    2025-11-26
    Enrolment
    15

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

    ConditionHead and Neck Squamous Cell Cancer
    InterventionBYL719
    PhaseNot applicable
    Registry statusCompleted