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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.

  • Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]

    NCT03292250 · start 2017-09-10

    Registered record
    Registry ID
    NCT03292250
    Conditions
    HNSCC; Head and Neck Neoplasms
    Interventions
    BYL719; Poziotinib; Nintedanib; Abemaciclib; Durvalumab,Tremelimumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2017-09-10
    Completion
    2022-03-10
    Enrolment
    180

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

    ConditionHNSCC; Head and Neck Neoplasms
    InterventionBYL719; Poziotinib; Nintedanib; Abemaciclib +1 more
    PhasePhase 2
    Registry statusCompleted

  • Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies

    NCT02620839 · start 2016-12-01

    Registered record
    Registry ID
    NCT02620839
    Conditions
    Solid Tumors
    Interventions
    Alpelisib; Cisplatin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2016-12-01
    Completion
    2019-01-28
    Enrolment
    28

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

    ConditionSolid Tumors
    InterventionAlpelisib; Cisplatin
    PhasePhase 1
    Registry statusTerminated

  • Cetuximab, Cisplatin and BYL719 for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

    NCT02298595 · start 2016-08

    Registered record
    Registry ID
    NCT02298595
    Conditions
    Carcinoma, Squamous; Squamous Cell Carcinoma; Oropharyngeal Neoplasms; Oropharyngeal Cancer
    Interventions
    cisplatin; Cetuximab; BYL719
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Withdrawn
    Start
    2016-08
    Completion
    2024-08
    Enrolment
    0

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

    ConditionCarcinoma, Squamous; Squamous Cell Carcinoma; Oropharyngeal Neoplasms; Oropharyngeal Cancer
    Interventioncisplatin; Cetuximab; BYL719
    PhasePhase 1 / Phase 2
    Registry statusWithdrawn

  • BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study

    NCT02550743 · start 2016-06-03

    Registered record
    Registry ID
    NCT02550743
    Conditions
    Rectal Cancer
    Interventions
    BYL719; Capecitabine; Radiation
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2016-06-03
    Completion
    2018-11-16
    Enrolment
    7

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

    ConditionRectal Cancer
    InterventionBYL719; Capecitabine; Radiation
    PhasePhase 1
    Registry statusTerminated

  • Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

    NCT02624557 · start 2015-12-21

    Registered record
    Registry ID
    NCT02624557
    Conditions
    Hepatic Impairment
    Interventions
    Alpelisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2015-12-21
    Completion
    2017-10-01
    Enrolment
    23

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

    ConditionHepatic Impairment
    InterventionAlpelisib
    PhasePhase 1
    Registry statusCompleted

  • BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer

    NCT02379247 · start 2015-02

    Registered record
    Registry ID
    NCT02379247
    Conditions
    Breast Cancer
    Interventions
    BYL-719 (alpelisib); Nab-paclitaxel
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2015-02
    Completion
    2022-03
    Enrolment
    43

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

    ConditionBreast Cancer
    InterventionBYL-719 (alpelisib); Nab-paclitaxel
    PhasePhase 1 / Phase 2
    Registry statusCompleted

  • A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

    NCT02276027 · start 2015-01-20

    Registered record
    Registry ID
    NCT02276027
    Conditions
    Adenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma
    Interventions
    BYL719; INC280; LDK378; MEK162
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2015-01-20
    Completion
    2019-10-15
    Enrolment
    66

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

    ConditionAdenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma
    InterventionBYL719; INC280; LDK378; MEK162
    PhasePhase 2
    Registry statusCompleted

  • Trial of AEB071 in Combination With BYL719 in Patients With Melanoma

    NCT02273219 · start 2014-11-19

    Registered record
    Registry ID
    NCT02273219
    Conditions
    Uveal Melanoma
    Interventions
    AEB071; BYL719
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-11-19
    Completion
    2018-07-02
    Enrolment
    30

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

    ConditionUveal Melanoma
    InterventionAEB071; BYL719
    PhasePhase 1
    Registry statusCompleted

  • Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma

    NCT02144038 · start 2014-07-23

    Registered record
    Registry ID
    NCT02144038
    Conditions
    Relapsed and Refractory Multiple Myeloma
    Interventions
    LGH447; BYL719
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-07-23
    Completion
    2015-10-28
    Enrolment
    20

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

    ConditionRelapsed and Refractory Multiple Myeloma
    InterventionLGH447; BYL719
    PhasePhase 1
    Registry statusCompleted

  • BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx

    NCT02038010 · start 2014-05-21

    Registered record
    Registry ID
    NCT02038010
    Conditions
    HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
    Interventions
    PI3K inhibitor BYL719; ado-trastuzumab emtansine; pharmacological study; laboratory biomarker analysis
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-05-21
    Completion
    2017-05-20
    Enrolment
    17

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

    ConditionHER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer +2 more
    InterventionPI3K inhibitor BYL719; ado-trastuzumab emtansine; pharmacological study; laboratory biomarker analysis
    PhasePhase 1
    Registry statusCompleted

  • Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors

    NCT02077933 · start 2014-05-14

    Registered record
    Registry ID
    NCT02077933
    Conditions
    Neoplasms; Breast Neoplasms; Kidney Neoplasms; Pancreatic Neuroendocine Neoplasms (pNETs)
    Interventions
    alpelisib; everolimus; exemestane
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-05-14
    Completion
    2019-04-12
    Enrolment
    79

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

    ConditionNeoplasms; Breast Neoplasms; Kidney Neoplasms; Pancreatic Neuroendocine Neoplasms (pNETs)
    Interventionalpelisib; everolimus; exemestane
    PhasePhase 1
    Registry statusCompleted

  • Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

    NCT01928459 · start 2013-10

    Registered record
    Registry ID
    NCT01928459
    Conditions
    Advanced Solid Tumors; Metastatic Solid Tumors
    Interventions
    BGJ398; BYL719
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-10
    Completion
    2016-08
    Enrolment
    62

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

    ConditionAdvanced Solid Tumors; Metastatic Solid Tumors
    InterventionBGJ398; BYL719
    PhasePhase 1
    Registry statusCompleted

  • BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer

    NCT01870505 · start 2013-05

    Registered record
    Registry ID
    NCT01870505
    Conditions
    Metastatic or Locally-advanced Unresectable Breast Cancer
    Interventions
    BYL719; Letrozole; Exemestane
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-05
    Completion
    2022-02-28
    Enrolment
    52

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

    ConditionMetastatic or Locally-advanced Unresectable Breast Cancer
    InterventionBYL719; Letrozole; Exemestane
    PhasePhase 1
    Registry statusCompleted

  • A Dose-finding Study of a Combination of Imatinib and BYL719 in the Treatment of 3rd Line GIST Patients

    NCT01735968 · start 2013-02-27

    Registered record
    Registry ID
    NCT01735968
    Conditions
    3rd Line GIST
    Interventions
    ST571 + BYL719
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-02-27
    Completion
    2018-10-19
    Enrolment
    56

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

    Condition3rd Line GIST
    InterventionST571 + BYL719
    PhasePhase 1
    Registry statusCompleted

  • A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors

    NCT01708161 · start 2012-11-27

    Registered record
    Registry ID
    NCT01708161
    Conditions
    PIK3CA Mutated Advanced Solid Tumors; PIK3CA Amplified Advanced Solid Tumors
    Interventions
    BYL719; AMG 479
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Terminated
    Start
    2012-11-27
    Completion
    2017-06-01
    Enrolment
    47

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

    ConditionPIK3CA Mutated Advanced Solid Tumors; PIK3CA Amplified Advanced Solid Tumors
    InterventionBYL719; AMG 479
    PhasePhase 1 / Phase 2
    Registry statusTerminated