Molecule
Zidesamtinib is a prescription medicine 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. MedsAcross supplies Zidesamtinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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. 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.
Source: US FDA prescribing information
Zidesamtinib is an inhibitor of tyrosine kinase ROS1, including ROS1 resistance mutations. In a biochemical assay, zidesamtinib inhibited ROS1 (IC 50 = 0.7 nM) and also showed inhibitory effects on ALK (IC 50 = 3 nM) and tropomyosin receptor kinases (TRKs), TRKB (IC 50 = 54 nM), TRKC (IC 50 = 193 nM) and TRKA (IC 50 = 258 nM). In vitro, zidesamtinib inhibited the viability of cultured cells expressing ROS1 fusion genes and resistance mutations (G2032R, S1986F, F2004C/V, L2026M, D2033N, and G2101A). In mice subcutaneously implanted with tumors harboring ROS1 fusions, including the G2032R mutation, administration of zidesamtinib resulted in tumor growth inhibition. Zidesamtinib had antitumor activity in an intracranial NSCLC xenograft model harboring a ROS1 fusion.
Source: US FDA prescribing information
Recommended Dosage: 100 mg orally once daily with or without food until disease progression or unacceptable toxicity. Recommended Testing and Evaluation Before Initiating JIDEYTRO Before initiating JIDEYTRO, evaluate creatine phosphokinase (CPK) level, electrocardiogram (ECG), electrolytes, lipase and amylase. Recommended Dosage The recommended dosage of JIDEYTRO is 100 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity. Swallow JIDEYTRO tablets whole. Do not split, chew, crush, or dissolve the tablet prior to swallowing. Missed Dose If a dose of JIDEYTRO is missed within 12 hours of the regularly scheduled dose, administer the missed dose as soon as possible. If a dose is missed by 12 hours or more, take the next dose at its scheduled time.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Central Nervous System (CNS) Adverse Reactions (AR): Can cause CNS AR including dizziness, ataxia, cognitive and psychiatric disorders. Based on severity, withhold JIDEYTRO and resume at same or reduced dose, or permanently discontinue. QTc Interval Prolongation: Can cause QTc prolongation. Evaluate ECGs and electrolytes prior to administration of JIDEYTRO and monitor periodically during treatment. Based on severity, withhold JIDEYTRO and resume at the same or reduced dose, or permanently discontinue. Interstitial Lung Disease (ILD)/pneumonitis: Can cause ILD/pneumonitis. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold in patients with suspected ILD/pneumonitis. Skeletal Fractures: Can cause skeletal fractures. Promptly evaluate patients with signs or symptoms of fractures.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System Adverse Reactions QTc Interval Prolongation Interstitial Lung Disease/Pneumonitis Skeletal Fractures Myalgia with Creatine Phosphokinase Elevation Pancreatic Toxicity Most common adverse reactions (≥15%) were: edema, peripheral neuropathy, constipation, fatigue, and dyspnea. Most common Grade 3 or 4 laboratory abnormalities (≥2%) were: increased CPK, increased triglycerides, decreased lymphocytes and decreased hemoglobin.
Source: US FDA prescribing information
Strong and Moderate CYP3A Inhibitors: Avoid concomitant use. Strong and Moderate CYP3A Inducers: Avoid concomitant use. Effects of Other Drugs on JIDEYTRO Strong and Moderate CYP3A Inhibitors Avoid concomitant use of JIDEYTRO with a strong or moderate CYP3A inhibitor. Zidesamtinib is a CYP3A substrate. Concomitant use with a strong or moderate CYP3A inhibitor increases zidesamtinib exposure, which may increase the risk of JIDEYTRO adverse reactions. Strong and Moderate CYP3A Inducers Avoid concomitant use of JIDEYTRO with strong or moderate CYP3A inducers. Concomitant use of JIDEYTRO with a strong or moderate CYP3A inducer may decrease zidesamtinib exposure, which may decrease the effectiveness of JIDEYTRO.
Source: US FDA prescribing information
Store JIDEYTRO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Zidesamtinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Jideytro 100 mg tabletOral | Nuvalent | US FDA | Available on request |
| Jideytro 25 mg tabletOral | Nuvalent | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 22 July 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 2 presentations of Zidesamtinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Zidesamtinib, including Jideytro.
Yes. The US FDA first approved Zidesamtinib on 22 July 2026, according to Drugs@FDA.
No listed presentation of Zidesamtinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.