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Augtyro

(Repotrectinib)

Phase 3Small molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Repotrectinib is a cancer medication that blocks abnormal proteins responsible for signaling cancer cells to grow and multiply. It is used to treat certain types of non-small cell lung cancer and solid tumors by helping to stop or slow the spread of cancer.[1] Augtyro is currently being investigated across 8 indications[3], with its most advanced program in Phase 3.[1]

Augtyro is one of 204 small molecule programs targeting NSCLC Stage IV. It is currently in Phase 3.

8

Indications

14

Total Trials

9

Active Trials

203

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

5

Patents

Pipeline

Status by Indication[3][1]

Indication

NSCLC Stage IVRecruiting

Solid TumorRecruiting

AdultRecruiting

OsimertinibRecruiting

NSCLCRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Solid Tumor CancerRecruiting

Patients With Advanced Solid TumorsRecruiting

NSCLC Stage IVPhase 2

Recruiting

Solid TumorPreclinical

Recruiting

AdultPhase 1

Recruiting

OsimertinibPhase 1

Recruiting

NSCLCPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Solid Tumor CancerPhase 2

Recruiting

Patients With Advanced Solid TumorsPhase 2

Recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Yervoy

Bristol-Myers Squibb

Tuoyi

SSun Yat-sen University

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Supportive Care Measures

Remeron

OOrganon and Co

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

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

Treatment

Valemetostat Tosylate

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT06140836

Q3 2027

PreclinicalRecruiting

Solid Tumor

NCT04094610

Q1 2028

Phase 1/2Recruiting

Patients With Advanced Solid Tumors

NCT03093116

Q2 2028

Phase 2Recruiting

NSCLC

NCT06315010

Clinical

Trials by Indication[1]

Hepatic Impairment2 trials

A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06352528·18 enrolled

A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

Withdrawn·TTurning Point Therapeutics, Inc.·Phase 1·NCT05828277

Solid Tumor2 trials

A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

Recruiting·TTurning Point Therapeutics, Inc.·Preclinical·NCT04094610·75 enrolled

Repotrectinib Post-Marketing Surveillance in Pediatric Patients (Age 4 to < 18) With NTRK Fusion-Positive Advanced/Recurrent Solid Tumors in Japan

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07755826·20 enrolled

ESS1 trial

Expanded Access for Repotrectinib

Available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05926232

Growth1 trial

Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT06408168·6 enrolled

Adult1 trial

Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT07223671·32 enrolled

7 more indications

Non-Small Cell Lung Cancer1 trial

A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06140836·190 enrolled

Osimertinib1 trial

Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients

Recruiting·IInstituto Oncológico Dr Rosell·Phase 1·NCT04772235·32 enrolled

Solid Tumor Cancer1 trial

A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT05004116·77 enrolled

Single Dose1 trial

A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06493409·32 enrolled

Patients With Advanced Solid Tumors1 trial

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Recruiting·TTurning Point Therapeutics, Inc.·Phase 1/2·NCT03093116·500 enrolled

NSCLC1 trial

A Phase II Study Assessing Safety and Efficacy of Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis (The REPOSE Study)

Recruiting·MMedSIR·Phase 2·NCT06315010·20 enrolled

NSCLC Stage IV1 trial

Open-label Phase II Efficacy Study of Repotrectinib in Frail (PS ≥2) and/or Elderly Patients With ROS1-rearranged Advanced NSCLC

Recruiting·CCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer·Phase 2·NCT06552234·30 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 15, 2023

AUGTYRO

NDA NDA218213

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Repotrectinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Repotrectinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Repotrectinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218213). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Augtyro. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Patent Landscape[5]

Patent Cliff

Jan 23, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE50634Jan 23, 2035

10294242Jul 5, 2036

12187739Jul 5, 2036

12310968Jul 20, 2036

11452725Jul 24, 2036

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