Vitrakvi

(Larotrectinib)

ApprovedSmall molecule

Vitrakvi is a small molecule that works as a TRK Inhibitor.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Vitrakvi is one of 298 small molecule programs targeting Glioma. It is currently in Approved.

Indications

Total Trials

Active Trials

297

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

GliomaRecruiting

FibrosarcomaActive, not recruiting

Tic DisorderActive, not recruiting

Metastatic Colorectal CancerRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Thyroid CancerNot yet recruiting

Locally Advanced Malignant Solid NeoplasmRecruiting

Advanced LymphomaActive, not recruiting

Advanced Malignant Solid NeoplasmActive, not recruiting

Differentiated Thyroid CancerRecruiting

GliomaPhase 1

Recruiting

FibrosarcomaPreclinical

Active, not recruiting

Tic DisorderPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Recruiting

Non-Small Cell Lung CancerApproved

Active, not recruiting

Thyroid CancerApproved

Not yet recruiting

Locally Advanced Malignant Solid NeoplasmPhase 2

Recruiting

Advanced LymphomaPhase 2

Active, not recruiting

Advanced Malignant Solid NeoplasmPhase 2

Active, not recruiting

Differentiated Thyroid CancerPhase 2

Recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Vitrakvi

Bayer

Approved

21 2

Taxol

Taxotere

Tiragolumab

9 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Advanced Lymphoma

NCT06390852

Q1 2027

Phase 2Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT03155620

Q3 2027

Phase 2Active, not recruiting

Acute Leukemia

NCT03834961

Q4 2027

Phase 2Recruiting

Locally Advanced Malignant Solid Neoplasm

NCT04879121

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Clinical

Trials by Indication[1]

Treatment2 trials

A Study Called VICTORIA to Learn More About How Well Larotrectinib Works in Adults With TRK Fusion-positive Cancer by Comparing Larotrectinib Data From Clinical Studies With Data of Other Treatments From Actual Practice

Completed· Bayer logo

Bayer··NCT05192642·368 enrolled

Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion

Approved for marketing· Bayer logo

Bayer··NCT03025360

Thyroid Cancer2 trials

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Recruiting·WWest China Hospital·Phase 2·NCT06482086·75 enrolled

Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

Not yet recruiting·FFujian Medical University·Phase 4·NCT07010393·335 enrolled

Advanced Lymphoma2 trials

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

MATCH Treatment Subprotocol Z1E: Larotrectinib (LOXO-101) in Patients With Tumors With NTRK Fusions

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06390852·16 enrolled

Tic Disorder1 trial

Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03213704·9 enrolled

Acute Leukemia1 trial

Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT03834961·33 enrolled

13 more indications

Metastatic Colorectal Cancer1 trial

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Glioma1 trial

A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion

Recruiting·NNationwide Children's Hospital·Phase 1·NCT04655404·15 enrolled

Fibrosarcoma1 trial

A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database

Completed· Bayer logo

Bayer··NCT05236257·93 enrolled

Unresectable1 trial

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Recruiting·SSun Yat-sen University·Phase 2·NCT06563999·120 enrolled

Safety and Efficacy1 trial

A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

Active, not recruiting· Bayer logo

Bayer·Phase 1/2·NCT02637687·154 enrolled

Cancer1 trial

A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

Completed· Bayer logo

Bayer·Phase 1·NCT02122913·75 enrolled

Glioblastoma Multiforme1 trial

Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients (BRAid GBM) Pilot Study

Not yet recruiting·OOlivia Newton-John Cancer Research Institute·Phase 1·NCT07908147·12 enrolled

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion1 trial

PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

Active, not recruiting· Bayer logo

Bayer··NCT04142437·54 enrolled

Differentiated Thyroid Cancer1 trial

Larotrectinib to Enhance RAI Avidity in Patients With Differentiated Thyroid Cancer Harboring NTRK Fusions (LANTERN)

Recruiting·CChildren's Hospital of Philadelphia·Phase 2·NCT05783323·13 enrolled

Locally Advanced Malignant Solid Neoplasm1 trial

A Phase II Basket Study of the Oral TRK Inhibitor Larotrectinib (BAY2757556) in Subjects With NTRK Amplification Positive and Pan-TRK Positive Tumors

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04879121·13 enrolled

Advanced Malignant Solid Neoplasm1 trial

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,377 enrolled

Solid Tumor1 trial

Special Drug Use Investigation for Larotrectinib

Recruiting· Bayer logo

Bayer··NCT04945330·100 enrolled

Unspecified1 trial

A Phase 1/2 Trial Of Larotrectinib And Pembrolizumab In Patients With Solid Tumors Previously Treated With Immune Checkpoint Inhibitor Monotherapy

Not yet recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07843550·22 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 26, 2018

VITRAKVI

NDA NDA211710

Nov 26, 2018

VITRAKVI

NDA NDA210861

Nov 26, 2018

VITRAKVI

NDA NDA210861

Nov 26, 2018

VITRAKVI

NDA NDA211710

Mar 25, 2021

VITRAKVI

NDA NDA211710

Mar 25, 2021

VITRAKVI

NDA NDA210861

Mar 25, 2021

VITRAKVI

NDA NDA210861

Mar 25, 2021

VITRAKVI

NDA NDA211710

Nov 23, 2022

VITRAKVI

NDA NDA211710

Nov 23, 2022

VITRAKVI

NDA NDA210861

Nov 3, 2023

VITRAKVI

NDA NDA210861

Nov 3, 2023

VITRAKVI

NDA NDA211710

Apr 9, 2025

VITRAKVI

NDA NDA211710

Apr 9, 2025

VITRAKVI

NDA NDA210861

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Larotrectinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Larotrectinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Larotrectinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211710). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vitrakvi. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Larotrectinib. U.S. National Library of Medicine.
[7]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: TRK Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Bayer

Patent Landscape[5]

Patent Cliff

Oct 21, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10774085Oct 21, 2029

8865698Oct 21, 2029

9676783Oct 21, 2029

10005783Oct 21, 2029

9447104Oct 21, 2029

15 more patents

10047097Oct 21, 2029

9127013Oct 21, 2029

8513263Dec 23, 2029

10285993Nov 16, 2035

10172861Nov 16, 2035

9782414Nov 16, 2035

10813936Nov 16, 2035

10799505Aug 15, 2036

10137127Apr 4, 2037

10045991Apr 4, 2037

11484535Apr 4, 2037

11191766Apr 4, 2037

10668072Apr 4, 2037

11974998May 16, 2037

11337967May 16, 2037

Key Publications[6]

Larotrectinib in TRK Fusion Cancer: Extended Efficacy Data

Lancet OncolNov 17, 2022DOI: 10.1016/S1470-2045(22)00616-2

Vitrakvi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Treatment2 trials

Thyroid Cancer2 trials

Advanced Lymphoma2 trials

Tic Disorder1 trial

Acute Leukemia1 trial

Metastatic Colorectal Cancer1 trial

Glioma1 trial

Fibrosarcoma1 trial

Unresectable1 trial

Safety and Efficacy1 trial

Cancer1 trial

Glioblastoma Multiforme1 trial

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion1 trial

Differentiated Thyroid Cancer1 trial

Locally Advanced Malignant Solid Neoplasm1 trial

Advanced Malignant Solid Neoplasm1 trial

Solid Tumor1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

Related News