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Pralsetinib

FDA-approved product (capsule, oral), marketed as Gavreto.

Registered studies
19
Lab records
0
Pathogens at ≥40%
4 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Cancer
  • Medullary thyroid gland carcinoma
  • Neoplasm
  • Non-small cell lung carcinoma

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

WHO therapeutic group
Other protein kinase inhibitors
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
  • MRSA57.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli52.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae41.5% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis58.8% 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

19registered 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.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.9 kcal/mol

0better fit →-12

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

-9.4 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.8 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 Pralsetinib 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.

  • Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors

    NCT07704658 · start 2026-03-04

    Registered record
    Registry ID
    NCT07704658
    Conditions
    NSCLC (Non-small Cell Lung Cancer); Thyroid Cancer; Solid Tumor Malignancies; Advanced Malignancies
    Interventions
    Pralsetinib; CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2026-03-04
    Completion
    2027-08-30
    Enrolment
    12

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

    ConditionNSCLC (Non-small Cell Lung Cancer); Thyroid Cancer; Solid Tumor Malignancies; Advanced Malignancies
    InterventionPralsetinib; CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive
    PhasePhase 4
    Registry statusRecruiting
  • A Real-world Study of Pralsetinib Combined With Leucogen in the Treatment of RET Fusion-positive NSCLC

    NCT07418879 · start 2026-02-05

    Registered record
    Registry ID
    NCT07418879
    Conditions
    Non-small Cell Lung Cancer; RET Fusion; Pralsetinib
    Interventions
    Pralsetinib; Leucogen
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Not yet recruiting
    Start
    2026-02-05
    Completion
    2028-12-31
    Enrolment
    25

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

    ConditionNon-small Cell Lung Cancer; RET Fusion; Pralsetinib
    InterventionPralsetinib; Leucogen
    PhaseNot applicable
    Registry statusNot yet recruiting
  • Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer

    NCT07419932 · start 2025-12-23

    Registered record
    Registry ID
    NCT07419932
    Conditions
    Thyroid Cancer; Thyroid Neoplasms
    Interventions
    Multitarget Tyrosine Kinase Inhibitors; BRAF inhibitor dabrafenib and MEK inhibitor trametinib; RET Inhibitor; PD(L)-1 inhibitor; Biopsy; Surgery; Surgery
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2025-12-23
    Completion
    2029-06-30
    Enrolment
    120

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

    ConditionThyroid Cancer; Thyroid Neoplasms
    InterventionMultitarget Tyrosine Kinase Inhibitors; BRAF inhibitor dabrafenib and MEK inhibitor trametinib; RET Inhibitor; PD(L)-1 inhibitor +3 more
    PhaseNot recorded
    Registry statusRecruiting
  • A Prospective Cohort Study of Pralsetinib or Anlotinib in the Treatment of Locally Advanced and/or Metastatic Medullary Thyroid Carcinoma With RET Gene Mutations

    NCT07048964 · start 2025-08-01

    Registered record
    Registry ID
    NCT07048964
    Conditions
    Medullary Thyroid Cancer (MTC)
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2025-08-01
    Completion
    2027-02-28
    Enrolment
    40

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

    ConditionMedullary Thyroid Cancer (MTC)
    InterventionNot recorded
    PhaseNot recorded
    Registry statusNot yet recruiting
  • Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

    NCT07010393 · start 2025-07-01

    Registered record
    Registry ID
    NCT07010393
    Conditions
    Thyroid Neoplasms
    Interventions
    Dabrafenib; Trametinib; Selpercatinib; Pralsetinib; Lenvatinib; Larotrectinib; Anlotinib; Pembrolizumab; Sintilimab; Cabozantinib; Bemosuzumab; Conversion Surgery
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Not yet recruiting
    Start
    2025-07-01
    Completion
    2028-12-31
    Enrolment
    335

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

    ConditionThyroid Neoplasms
    InterventionDabrafenib; Trametinib; Selpercatinib; Pralsetinib +8 more
    PhasePhase 4
    Registry statusNot yet recruiting
  • Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

    NCT06563999 · start 2024-11-01

    Registered record
    Registry ID
    NCT06563999
    Conditions
    Lung Cancer Stage III; Mutation
    Interventions
    Sunvozertinib; Crizotinib; Pralsetinib; Larotrectinib; Savolitinib; Pyrotinib; Dabrafenib+Trametinib; Glecirasib; Ensartinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-11-01
    Completion
    2029-11-01
    Enrolment
    120

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

    ConditionLung Cancer Stage III; Mutation
    InterventionSunvozertinib; Crizotinib; Pralsetinib; Larotrectinib +5 more
    PhasePhase 2
    Registry statusRecruiting
  • A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).

    NCT04760288 · start 2023-11-30

    Registered record
    Registry ID
    NCT04760288
    Conditions
    Medullary Thyroid Cancer
    Interventions
    Pralsetinib; Cabozantinib; Vandetanib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Withdrawn
    Start
    2023-11-30
    Completion
    2035-04-12
    Enrolment
    0

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

    ConditionMedullary Thyroid Cancer
    InterventionPralsetinib; Cabozantinib; Vandetanib
    PhasePhase 3
    Registry statusWithdrawn
  • KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

    NCT05525858 · start 2022-09-28

    Registered record
    Registry ID
    NCT05525858
    Conditions
    Solid Tumor; Advanced Solid Tumor; Metastatic Cancer
    Interventions
    Alectinib; Atezolizumab; Erlotinib; Trastuzumab + Pertuzumab; Trastuzumab emtansine; Vemurafenib; Bevacizumab + Erlotinib; Entrectinib; Pralsetinib
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2022-09-28
    Completion
    2027-03
    Enrolment
    1,000

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

    ConditionSolid Tumor; Advanced Solid Tumor; Metastatic Cancer
    InterventionAlectinib; Atezolizumab; Erlotinib; Trastuzumab + Pertuzumab +5 more
    PhaseNot recorded
    Registry statusRecruiting
  • Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

    NCT06482086 · start 2021-06-01

    Registered record
    Registry ID
    NCT06482086
    Conditions
    Locally Advanced Thyroid Gland Carcinoma
    Interventions
    Anlotinib; Lenvatinib; Sorafenib; Donafenib; Everolimus; Apatinib; Dabrafenib + Trametinib; Cabozantinib; Vandetanib; Entrectinib; Pralsetinib; Larotrectinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2021-06-01
    Completion
    2025-12-01
    Enrolment
    75

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

    ConditionLocally Advanced Thyroid Gland Carcinoma
    InterventionAnlotinib; Lenvatinib; Sorafenib; Donafenib +8 more
    PhasePhase 2
    Registry statusRecruiting
  • Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

    NCT04589845 · start 2021-01-18

    Registered record
    Registry ID
    NCT04589845
    Conditions
    Solid Tumors
    Interventions
    Entrectinib; Entrectinib; Alectinib; Atezolizumab; Ipatasertib; Trastuzumab emtansine; Inavolisib; Belvarafenib; Pralsetinib; Divarasib; Camonsertib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2021-01-18
    Completion
    2032-09-25
    Enrolment
    920

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

    ConditionSolid Tumors
    InterventionEntrectinib; Entrectinib; Alectinib; Atezolizumab +7 more
    PhasePhase 2
    Registry statusActive not recruiting
  • A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

    NCT04632992 · start 2021-01-13

    Registered record
    Registry ID
    NCT04632992
    Conditions
    Advanced Unresectable or Metastatic Solid Malignancy
    Interventions
    Entrectinib; Inavolisib; Alectinib; Ipatasertib; Atezolizumab; Trastuzumab Emtansine; Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf; Tucatinib; Investigator's Choice of Chemotherapy; Paclitaxel; Tiragolumab; Pralsetinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2021-01-13
    Completion
    2024-02-27
    Enrolment
    252

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

    ConditionAdvanced Unresectable or Metastatic Solid Malignancy
    InterventionEntrectinib; Inavolisib; Alectinib; Ipatasertib +8 more
    PhasePhase 2
    Registry statusCompleted
  • External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC

    NCT04697446 · start 2020-12-01

    Registered record
    Registry ID
    NCT04697446
    Conditions
    RET-fusion Non Small Cell Lung Cancer; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Diseases; Head and Neck Neoplasms; Carcinoma; Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Metastatic Non Small Cell Lung Cancer
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2020-12-01
    Completion
    2021-10-31
    Enrolment
    279

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

    ConditionRET-fusion Non Small Cell Lung Cancer; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms +13 more
    InterventionNot recorded
    PhaseNot recorded
    Registry statusUnknown
  • A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

    NCT04302025 · start 2020-11-06

    Registered record
    Registry ID
    NCT04302025
    Conditions
    Non-small Cell Lung Cancer
    Interventions
    Alectinib; Entrectinib; Vemurafenib; Cobimetinib; Pralsetinib; Atezolizumab; SBRT; Resection; Chemotherapy; Divarasib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2020-11-06
    Completion
    2030-05-30
    Enrolment
    99

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

    ConditionNon-small Cell Lung Cancer
    InterventionAlectinib; Entrectinib; Vemurafenib; Cobimetinib +6 more
    PhasePhase 2
    Registry statusRecruiting
  • The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

    NCT04591431 · start 2020-10-07

    Registered record
    Registry ID
    NCT04591431
    Conditions
    Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer
    Interventions
    Erlotinib; Trastuzumab; Trastuzumab emtansine; Pertuzumab; Lapatinib; Everolimus; Vemurafenib; Cobimetinib; Alectinib; Brigatinib; Palbociclib; Ponatinib; Vismogedib; Itacitinib; Ipatasertib; Entrectinib; Atezolizumab; Nivolumab; Ipilimumab; Pemigatinib; Oncology Drugs; Pralsetinib; Selpercatinib; Talazoparib; Tepotinib; Alpelisib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2020-10-07
    Completion
    2025-06
    Enrolment
    400

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

    ConditionBreast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer
    InterventionErlotinib; Trastuzumab; Trastuzumab emtansine; Pertuzumab +22 more
    PhasePhase 2
    Registry statusUnknown
  • A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

    NCT04222972 · start 2020-07-24

    Registered record
    Registry ID
    NCT04222972
    Conditions
    RET-fusion Non Small Cell Lung Cancer; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Disease; Carcinoma, Bronchogenic; Bronchial Diseases; Head and Neck Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue
    Interventions
    Pralsetinib; Carboplatin; Cisplatin; Pemetrexed; Pembrolizumab; Gemcitabine; Paclitaxel; Nab-Paclitaxel
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2020-07-24
    Completion
    2025-01-27
    Enrolment
    223

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

    ConditionRET-fusion Non Small Cell Lung Cancer; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms +13 more
    InterventionPralsetinib; Carboplatin; Cisplatin; Pemetrexed +4 more
    PhasePhase 3
    Registry statusTerminated