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Zidesamtinib

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Jideytro

Nuvalent, Inc.

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    0

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    NDA220185,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Nuvalent, Inc. Source: Company record for Nuvalent, Inc. (opens in a new tab)
Indications
Not recorded
Application
NDA 220185 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 220185 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Completed
  5. Filed Completed
  6. Approved Current stageFirst approval 22 Jul 2026

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Zidesamtinib. Editors add each one with its source.

Filed application

No filed application is on record for Zidesamtinib. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Zidesamtinib.

Clinical trials

No trials are linked to this drug yet.

Trial quality

About CT-VCA

Loading trial quality…

FDA actions

Original approvals and new-indication supplements for Zidesamtinib, newest first
ApplicationActionDateOutcomeReviewSource
NDA220185Action letter for NDA220185 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedstandardDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as Zidesamtinib.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.