PharmaRadar360

PharmaRadar360

OncologyDrug intelligence

Jideytro

Zidesamtinib

ROS1 tyrosine kinase inhibitor. Developed by Nuvalent. Clinical, regulatory, and source evidence are connected below.

Company
Nuvalent
Target / MOA
ROS1
Aliases
Jideytro
Signals
2
Clinical trials
2
Approvals
0
Evidence sources
2

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Jideytro 路 NDA220185 路 label version 5, effective Jul 22, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] .

European Union (EMA)

EMA's medicines data lists no marketing authorisation for this medicine.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

NDA220185 路 NUVALENT 路 first approved Jul 22, 2026

European Union

EMA's medicines data lists no marketing authorisation for this medicine.

    Patents and exclusivity

    What FDA lists (US)

    Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

    NDA220185 (Orange Book)

    4 listed patents, latest expiry Sep 30, 2042
    • US 11542278 路 expires May 5, 2041 路 drug substance, drug product
    • US 12054498 路 expires May 5, 2041 路 U-4579
    • US 12043626 路 expires Sep 30, 2042 路 drug substance, drug product
    • US 12630560 路 expires Sep 30, 2042 路 U-4579

    Exclusivity: NCE until Jul 22, 2031 路 Orange Book entry

    Generics and biosimilars

    The Orange Book lists no approved generic (ANDA).

    FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

    Safety

    Boxed warnings and FDA safety communications

    The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

    Boxed warning

    The current US label has no boxed warning.

    FDA Drug Safety Communications

    None on FDA's list names this drug.

    Clinical trials

    Key active studies

    A focused view of recently updated studies 路 2 linked records.

    Phase 1RECRUITINGNCT05118789

    A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

    Nuvalent Inc. 路 Updated Sep 24, 2026

    N/AAVAILABLENCT06797362

    Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors

    Nuvalent Inc. 路 Updated Aug 25, 2026

    Regulatory timeline

    Approvals and agency activity

    Verified regulatory records in reverse chronological order.

    No regulatory event is available in this snapshot.

    Source evidence

    Where this profile comes from

    Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

    ClinicalTrials.govofficial 路 Latest Sep 24, 20262
    Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.