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.

  • A Study of Clinical Practice and Real-world Care of Patients Treated With mTOR, PI3K, and MEK Inhibitors for Extracranial Vascular Anomalies

    NCT07767877 · start 2026-09-30

    Registered record
    Registry ID
    NCT07767877
    Conditions
    Vascular Anomalies
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2026-09-30
    Completion
    2027-10-29
    Enrolment
    200

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

    ConditionVascular Anomalies
    InterventionNot recorded
    PhaseNot recorded
    Registry statusNot yet recruiting

  • EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

    NCT06997588 · start 2025-10-09

    Registered record
    Registry ID
    NCT06997588
    Conditions
    PIK3CA-related Overgrowth Spectrum (PROS)
    Interventions
    Alpelisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-10-09
    Completion
    2030-09-30
    Enrolment
    104

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

    ConditionPIK3CA-related Overgrowth Spectrum (PROS)
    InterventionAlpelisib
    PhasePhase 2
    Registry statusRecruiting

  • 24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs

    NCT07543822 · start 2025-08-27

    Registered record
    Registry ID
    NCT07543822
    Conditions
    Vascular Anomalies; Vascular Anomaly; TIE2/PIK3CA Pathway Driven Vascular Anomalies
    Interventions
    alpelisib (BYL719)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2025-08-27
    Completion
    2030-08-27
    Enrolment
    61

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

    ConditionVascular Anomalies; Vascular Anomaly; TIE2/PIK3CA Pathway Driven Vascular Anomalies
    Interventionalpelisib (BYL719)
    PhasePhase 2
    Registry statusActive not recruiting

  • Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

    NCT06739395 · start 2024-11-01

    Registered record
    Registry ID
    NCT06739395
    Conditions
    Solid Tumor; Precision Medicine
    Interventions
    Olaparib tablet; Temozolomide capsule; Anlotinib; Trametinib tablet; Dabrafenib; Vebreltinib Enteric Capsules; Alpelisib Pill; Sacituzumab Govitecan-Hziy 180 MG; Lenvatinib Capsules; Pazopanib Pill; Palbociclib Pill; Chidamide; PD-1/PD-L1/PD-1&CTLA4 inhibitor; Target Gene
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-11-01
    Completion
    2027-05-01
    Enrolment
    300

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

    ConditionSolid Tumor; Precision Medicine
    InterventionOlaparib tablet; Temozolomide capsule; Anlotinib; Trametinib tablet +10 more
    PhasePhase 2
    Registry statusRecruiting

  • A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

    NCT05154487 · start 2024-09-11

    Registered record
    Registry ID
    NCT05154487
    Conditions
    Endometroid Endometrial Cancer
    Interventions
    Alpelisib Pill; Fulvestrant injection
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2024-09-11
    Completion
    2028-11-01
    Enrolment
    51

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

    ConditionEndometroid Endometrial Cancer
    InterventionAlpelisib Pill; Fulvestrant injection
    PhasePhase 2
    Registry statusActive not recruiting

  • Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing

    NCT06145308 · start 2023-08-15

    Registered record
    Registry ID
    NCT06145308
    Conditions
    Salivary Gland Carcinoma; Precision Therapy
    Interventions
    Cohort 1 (HER2-positive, RC48-ADC); Cohort 2 (NTRK-fusion or NTRK-mutant); Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone); TROP2 ADC; TKI; Albumin-paclitaxel + platinum; Albumin-paclitaxel + carboplatin + apatinib + camrelizumab; albumin-bound paclitaxel+trastuzumab+pyrotinib; HER2,trastuzumab deruxtecan± pertuzumab; AR,AR antagonist ++ goserelin + pertuzumab + trastuzumab; AR,AR antagonist +goserelin +docetaxel; ivonescimab + investigator-choice platinum doublet+; iparomlimab + tuvonralimab; cadonilimab; CDK4/6 inhibitor+AI or fulvestrant; alpelisib+fulvestrant; PARP inhibitor; enfortumab vedotin; HER2, pyrotinib + pertuzumab/trastuzumab; vebecotutamab ±lenvatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-08-15
    Completion
    2028-07-10
    Enrolment
    39

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

    ConditionSalivary Gland Carcinoma; Precision Therapy
    InterventionCohort 1 (HER2-positive, RC48-ADC); Cohort 2 (NTRK-fusion or NTRK-mutant); Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone); TROP2 ADC +16 more
    PhasePhase 2
    Registry statusRecruiting

  • A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

    NCT04967248 · start 2023-06-21

    Registered record
    Registry ID
    NCT04967248
    Conditions
    Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
    Interventions
    Alpelisib; Fulvestrant
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Terminated
    Start
    2023-06-21
    Completion
    2024-10-18
    Enrolment
    4

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

    ConditionHormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
    InterventionAlpelisib; Fulvestrant
    PhaseNot recorded
    Registry statusTerminated

  • 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

  • Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

    NCT05564377 · start 2023-04-07

    Registered record
    Registry ID
    NCT05564377
    Conditions
    Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm; Malignant Female Reproductive System Neoplasm; Metastatic HER2-Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Unresectable HER2-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm
    Interventions
    Alpelisib; Binimetinib; Biopsy Procedure; Biospecimen Collection; Bone Marrow Aspiration; Bone Marrow Biopsy; Bone Scan; Computed Tomography; Echocardiography Test; Fluorouracil; Fulvestrant; Ipatasertib; Leucovorin; Magnetic Resonance Imaging; Multigated Acquisition Scan; Mutation Carrier Screening; Neratinib Maleate; Nilotinib Hydrochloride Monohydrate; Olaparib; Oxaliplatin; Paclitaxel; Palbociclib; Panitumumab; Positron Emission Tomography; Selumetinib Sulfate; Sotorasib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-04-07
    Completion
    2030-07-01
    Enrolment
    2,900

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

    ConditionAdvanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm +11 more
    InterventionAlpelisib; Binimetinib; Biopsy Procedure; Biospecimen Collection +22 more
    PhasePhase 2
    Registry statusRecruiting

  • Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

    NCT05101564 · start 2023-03-20

    Registered record
    Registry ID
    NCT05101564
    Conditions
    Breast Cancer; HER2-negative Breast Cancer; ER Positive Breast Cancer
    Interventions
    Alpelisib; Tamoxifen; Zotatifin; Fulvestrant
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2023-03-20
    Completion
    2024-06-03
    Enrolment
    19

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

    ConditionBreast Cancer; HER2-negative Breast Cancer; ER Positive Breast Cancer
    InterventionAlpelisib; Tamoxifen; Zotatifin; Fulvestrant
    PhasePhase 2
    Registry statusCompleted

  • Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)

    NCT05660083 · start 2023-01-12

    Registered record
    Registry ID
    NCT05660083
    Conditions
    HER2-negative Breast Cancer; Metastatic Breast Cancer; Metaplastic Breast Carcinoma; TNBC - Triple-Negative Breast Cancer
    Interventions
    L-NMMA
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-01-12
    Completion
    2028-12-02
    Enrolment
    36

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

    ConditionHER2-negative Breast Cancer; Metastatic Breast Cancer; Metaplastic Breast Carcinoma; TNBC - Triple-Negative Breast Cancer
    InterventionL-NMMA
    PhasePhase 2
    Registry statusRecruiting

  • Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

    NCT05501886 · start 2022-12-08

    Registered record
    Registry ID
    NCT05501886
    Conditions
    Breast Cancer
    Interventions
    Gedatolisib; Palbociclib; Fulvestrant; Alpelisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2022-12-08
    Completion
    2026-12-31
    Enrolment
    701

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

    ConditionBreast Cancer
    InterventionGedatolisib; Palbociclib; Fulvestrant; Alpelisib
    PhasePhase 3
    Registry statusActive not recruiting

  • Assessment of the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)

    NCT05577754 · start 2022-11-28

    Registered record
    Registry ID
    NCT05577754
    Conditions
    Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)
    Interventions
    Alpelisib (BYL719); Matching placebo; Optional lumbar puncture + blood sample
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2022-11-28
    Completion
    2027-03
    Enrolment
    20

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

    ConditionMegalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)
    InterventionAlpelisib (BYL719); Matching placebo; Optional lumbar puncture + blood sample
    PhasePhase 2
    Registry statusRecruiting

  • Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

    NCT05508906 · start 2022-08-31

    Registered record
    Registry ID
    NCT05508906
    Conditions
    Metastatic Breast Cancer; ER-positive Breast Cancer; HER2-negative Breast Cancer; Breast Cancer; Locally Advanced Breast Cancer
    Interventions
    Palazestrant; Ribociclib; Alpelisib; Everolimus; Atirmociclib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2022-08-31
    Completion
    2028-01-31
    Enrolment
    190

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

    ConditionMetastatic Breast Cancer; ER-positive Breast Cancer; HER2-negative Breast Cancer; Breast Cancer +1 more
    InterventionPalazestrant; Ribociclib; Alpelisib; Everolimus +1 more
    PhasePhase 1
    Registry statusActive not recruiting

  • SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

    NCT05392608 · start 2022-06-02

    Registered record
    Registry ID
    NCT05392608
    Conditions
    Neoplasm, Breast; Congenital, Familial and Genetic Disorders
    Interventions
    Alpelisib 150 MG Oral Tablet [Piqray]; Fulvestrant
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2022-06-02
    Completion
    2028-03
    Enrolment
    130

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

    ConditionNeoplasm, Breast; Congenital, Familial and Genetic Disorders
    InterventionAlpelisib 150 MG Oral Tablet [Piqray]; Fulvestrant
    PhasePhase 2
    Registry statusActive not recruiting