Molecule
Taletrectinib adipate is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). It is available as capsules for oral use. MedsAcross supplies Taletrectinib adipate 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.
IBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). IBTROZI is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).
Source: US FDA prescribing information
Taletrectinib is an inhibitor of tyrosine kinase ROS1, including ROS1 resistance mutations. Taletrectinib also showed inhibitory effects on tropomyosin receptor kinases (TRKs) TRKA, TRKB, and TRKC. Fusion proteins that include ROS1 domains can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to unconstrained cell proliferation. Taletrectinib inhibited growth of cancer cells expressing ROS1 fusion genes and mutations. In mice subcutaneously implanted with tumors harboring ROS1 fusions, including the G2032R mutation, administration of taletrectinib resulted in tumor growth inhibition. Taletrectinib had anticancer activity in an intracranial NSCLC xenograft model harboring a ROS1 fusion.
Source: US FDA prescribing information
Select patients for the treatment of locally advanced or metastatic NSCLC based on the presence of ROS1 rearrangement(s). Recommended Dosage: 600 mg orally once daily on an empty stomach (no food intake at least 2 hours before and 2 hours after taking IBTROZI). Continue treatment until disease progression or unacceptable toxicity.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Hepatotoxicity: Monitor liver function tests prior to initiating, every 2 weeks during the first 2 months of treatment, then monthly thereafter as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Based on severity and resolution, withhold and then resume at reduced dose, or permanently discontinue. Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold in patients with suspected ILD/pneumonitis. Based on severity and resolution, resume at the same or reduced dose, or permanently discontinue. QTc Interval Prolongation: Monitor ECG and electrolytes prior to initiating and periodically during treatment. Based on severity and resolution, withhold and then resume at same or reduced dose, or permanently discontinue.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in the WARNINGS AND PRECAUTIONS section: Hepatotoxicity Interstitial Lung Disease/Pneumonitis QTc Interval Prolongation Hyperuricemia Myalgia with Creatine Phosphokinase Elevation Skeletal fractures The most frequently reported adverse reactions (≥20%) were: diarrhea, nausea, vomiting, dizziness, rash, constipation, and fatigue. The most frequently reported Grade 3 or 4 laboratory abnormalities (≥2%) were: increased ALT, increased AST, decreased neutrophils, and increased creatine phosphokinase, decreased lymphocytes, increased magnesium, decreased hemoglobin, and increased triglycerides.
Source: US FDA prescribing information
Strong and Moderate CYP3A inhibitors: Avoid concomitant use. Strong and Moderate CYP3A inducers: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with proton pump inhibitors (PPIs) and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer IBTROZI 2 hours before or 2 hours after taking a locally acting antacid. Drugs That Prolong the QTc Interval: Avoid concomitant use.
Source: US FDA prescribing information
Store IBTROZI at 20°C to 25°C (68°F to 77°F), excursions are permitted to 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.
1 presentations of Taletrectinib adipate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ibtrozi 272 mg capsuleOral | Nuvation Bio | 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 11 June 2025 | 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 1 presentations of Taletrectinib adipate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Taletrectinib adipate, including Ibtrozi.
Yes. The US FDA first approved Taletrectinib adipate on 11 June 2025, according to Drugs@FDA.
No listed presentation of Taletrectinib adipate 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.