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Taletrectinib · Ibtrozi, AB-106

Small molecule · Inhibitor of ROS1 · developed by Nuvation

Approved FDA, Jun 2025
NUVB Developer
7 Registered trials

What is Taletrectinib?

Taletrectinib is an orally available kinase inhibitor that binds and inhibits ROS1, including ROS1 resistance mutations, and also inhibits TRKA, TRKB and TRKC. It blocks ROS1- and TRK-driven signaling that promotes unconstrained cell proliferation in tumor cells. It is studied in non-small cell lung cancer and solid tumors.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Ibtrozi, AB-106, DS-6051b, DS-6051a, DS-6051, Investigational product
Drug type
Small molecule
Targets
ROS1, TRKA (NTRK1) (NTRK1) (secondary target), TRKB (NTRK2) (NTRK2) (secondary target), TRKC (NTRK3) (NTRK3) (secondary target)
Mechanism
Inhibitor of ROS1
Pathways
ROS1 downstream signaling, TRK signaling
Therapy area
Oncology
Developer
Nuvation (NUVB)
FDA status
Approved as Ibtrozi (June 11, 2025), NDA219713 · FDA label
UNII
W4141180YD

✅ FDA-approved uses

From the indications section of the FDA label (version of Mar 23, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT06564324 Phase 3 Non Small Cell Lung Cancer Recruiting NUVB
NCT04395677 Phase 2 Non Small Cell Lung Cancer Active not recruiting NUVB
NCT07742384 Phase 1 Healthy Adult Participants Not yet recruiting NUVB
NCT05609929 Phase 1 Pharmacokinetic Study Completed NUVB
NCT05357820 Phase 1 Solid Tumor Completed NUVB
NCT05357911 Phase 1 Solid Tumor Completed NUVB
NCT02279433 Phase 1 Solid Tumors Completed NUVB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Healthy Adult ParticipantsNon Small Cell Lung CancerPharmacokinetic StudySolid Tumor

Other drugs acting on ROS1

More from Nuvation

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the NUVB page.

Follow NUVB, the company behind Taletrectinib

See NUVB's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.