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

Augtyro is one of 54 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 3.

3

Indications

13

Total Trials

8

Active Trials

53

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

5

Patents

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerActive, not recruiting

NSCLC Stage IVRecruiting

GrowthActive, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

NSCLC Stage IVPhase 2

Recruiting

GrowthPhase 2

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

PORTRAZZA

Lenvima

Imjudo

Vizimpro

Gilotrif

Boehringer Ingelheim

Ofev

Boehringer Ingelheim

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Treatment

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

Phase 1/2Recruiting

Adult Subject

NCT04094610

Q1 2028

Phase 1/2Recruiting

Patients With Advanced Solid Tumors

NCT03093116

Q2 2028

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT06315010

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

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

REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis

Recruiting·MMedSIR·Phase 2·NCT06315010·20 enrolled

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

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

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

Adult Subject1 trial

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

Recruiting·TTurning Point Therapeutics, Inc.·Phase 1/2·NCT04094610·75 enrolled

6 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

Osimertinib1 trial

Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients

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

ESS1 trial

Expanded Access for Repotrectinib

Available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05926232

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

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

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 — 13 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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