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Augtyro

(Repotrectinib)

Phase 2Small 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 7 indications[3], with its most advanced program in Phase 2.[1]

Augtyro is one of 165 small molecule programs targeting Solid Tumor. It is currently in Phase 2.

7

Indications

15

Total Trials

10

Active Trials

164

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

5

Patents

Pipeline

Status by Indication[3][1]

Indication

Solid TumorRecruiting

NSCLCRecruiting

AdultRecruiting

Solid Tumor CancerRecruiting

NSCLC Stage IVRecruiting

Patients With Advanced Solid TumorsRecruiting

OsimertinibRecruiting

Solid TumorPreclinical

Recruiting

NSCLCPhase 2

Recruiting

AdultPhase 1

Recruiting

Solid Tumor CancerPhase 2

Recruiting

NSCLC Stage IVPhase 2

Recruiting

Patients With Advanced Solid TumorsPhase 2

Recruiting

OsimertinibPhase 1

Recruiting

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Fludara

Navmi

SSummit Therapeutics

Proleukin

IIovance Biotherapeutics, Inc.

PD-1 Inhibitor

Johnson & Johnson

Tulmimetostat

Ifinatamab Deruxtecan

Carboplatin AUC-5

IL-2

FFate Therapeutics

Interleukin 2

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT06140836

Q3 2027

PreclinicalRecruiting

Solid Tumor

NCT04094610

Q1 2028

Not yet recruiting

Non-Small Cell Lung Cancer

NCT07599007

Phase 1/2Recruiting

Patients With Advanced Solid Tumors

NCT03093116

Q2 2028

Phase 2Recruiting

NSCLC

NCT06315010

Clinical

Trials by Indication[1]

Hepatic Impairment2 trials

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Withdrawn·TTurning Point Therapeutics, Inc.·Phase 1·NCT05828277

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

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, or NTRK1-3 Alterations (CARE)

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

Osimertinib1 trial

Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients

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

ESS1 trial

Expanded Access for Repotrectinib

Available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05926232

8 more indications

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

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

Non-Small Cell Lung Cancer1 trial

AUGTYRO™ (Repotrectinib) Post-Marketing Surveillance in Korean Patients With Locally Advanced or Metastatic Ros1-Positive NSCLC or Solid Tumors Harboring a NTRK Gene Fusion

Not yet recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07599007·10 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

Randomized, Open-label, Multicenter, Phase 3 Trial 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

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 — 15 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 2[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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