Prescription medicine
Zidesamtinib Brand names: Jideytro
Zidesamtinib (Jideytro) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the zidesamtinib FDA label on DailyMed (effective July 22, 2026, Nuvalent, Inc.); the NDA 220185 record on Drugs@FDA; every zidesamtinib label on DailyMed.
Highlights of the record
FDA label of July 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageJIDEYTRO 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 )].
Forms and strengths
- 25 mg
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 22, 2026 Jideytro, Nuvalent; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 30, 2042 Jideytro tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is zidesamtinib used for?
From the label: indications and usageJIDEYTRO 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 )]. JIDEYTRO is a kinase inhibitor 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.
Conditions named in the indications of zidesamtinib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (JIDEYTRO), Nuvalent, Inc., effective July 22, 2026 (SPL set 3760e421-b523-4d9b-e063-6394a90ab94b), via openFDA; the full label on DailyMed
What does the patient leaflet for zidesamtinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking JIDEYTRO?Do not drive or operate heavy machinery during treatment if you develop side effects that can impact your mental alertness or coordination. See "Central nervous system (CNS) effects" in the "What are the possible side effects of JIDEYTRO?" section below.
From the patient leaflet: How should I store JIDEYTRO?Store JIDEYTRO at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Keep JIDEYTRO and all medicines out of the reach of children.
Source: FDA drug label (JIDEYTRO), Nuvalent, Inc., effective July 22, 2026 (SPL set 3760e421-b523-4d9b-e063-6394a90ab94b), via openFDA; the full label on DailyMed
Is there a generic for zidesamtinib (Jideytro)?
No generic zidesamtinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Jideytro tablets: the compound patent runs to September 30, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2026 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What else is labeled for the same conditions as zidesamtinib?
26 other medicines are given the same way (oral) and in the same FDA class as zidesamtinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Dacomitinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as zidesamtinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to zidesamtinib
- 26 medicines for the same use
- Check an interaction
- what two or more labels say about each other