Zidesamtinib · Jideytro, NVL-520

What is Zidesamtinib?

Zidesamtinib is an oral small-molecule inhibitor of the tyrosine kinase ROS1, including ROS1 resistance mutations, with secondary activity against ALK and tropomyosin receptor kinases (TRK). It inhibits proliferation of ROS1-driven tumor cells and has antitumor activity in non-small cell lung cancer models, including intracranial disease.

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

At a glance

Also known as

Jideytro, NVL-520, NU-0002362, NU-0002362-009, NU-2362-010

Drug type

Small molecule

Targets

ROS1, ALK (secondary target), TRKA (NTRK1) (secondary target), TRKB (NTRK2) (secondary target), TRKC (NTRK3) (secondary target)

Mechanism

Inhibitor of ROS1

Pathways

cell proliferation inhibition, downstream signaling disruption

Therapy area

Oncology

Developer

Nuvalent (NUVL)

FDA status

Approved as Jideytro (July 22, 2026), NDA220185 · FDA label

UNII

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✅ FDA-approved uses

• Locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor

From the indications section of the FDA label (version of Jul 22, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

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

Conditions studied

Locally Advanced Solid TumorMetastatic Solid TumorNon Small Cell Lung CancerROS1-positive Non-Small Cell Lung Cancer (NSCLC)

Other drugs acting on ROS1

More from Nuvalent

Sources

• FDA label (DailyMed)
• FDA label Jideytro (2026-07-22), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT05118789

Updated Oct 3, 2026. Something wrong or missing? Report it on the NUVL page.