Ibtrozi (Taletrectinib) 200mg Capsules | ROS1 Inhibitor | GLT

Generic Information: Ibtrozi (Taletrectinib) — Nuvation Bio US Originator

Taletrectinib is the active ingredient of Ibtrozi, a next-generation, highly selective ROS1 tyrosine kinase inhibitor developed by AnHeart Therapeutics and now marketed in the United States by Nuvation Bio, Inc. This page covers the 200 mg capsule supplied in two pack sizes — 30 capsules and 90 capsules. Taletrectinib was originally discovered by Daiichi Sankyo (development code DS-6051b/AB-106), in-licensed by AnHeart in 2018, and AnHeart was subsequently acquired by Nuvation Bio in 2024. The U.S. FDA approved Ibtrozi in June 2025 for ROS1-positive non-small cell lung cancer under priority review, with breakthrough therapy designation granted for both treatment-naive and previously treated patients. It is the same molecule sold in China as 达伯乐 (DOVBLERON) by Innovent Biologics, representing a single drug marketed under two different brand names in different regions.

What Is Ibtrozi (Taletrectinib) Used For?

Ibtrozi is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). ROS1 fusions occur in roughly 2% of NSCLC patients and define a distinct molecular subtype that responds to ROS1 inhibitors. Ibtrozi is a second-generation ROS1 inhibitor designed to overcome the key limitations of earlier drugs: it penetrates the blood-brain barrier to treat brain metastases, and it retains activity against resistant mutations such as G2032R that emerge after first-generation ROS1 inhibitor treatment. This makes it a treatment-line-agnostic option, approved for both patients who have never received a ROS1 inhibitor and those whose disease has progressed on a prior one.

How Does Ibtrozi (Taletrectinib) Work?

Ibtrozi works by selectively binding and inhibiting the ROS1 kinase, the abnormal fusion protein that drives uncontrolled cell growth in ROS1-positive NSCLC. By blocking ROS1, it shuts down the downstream signaling pathways that fuel tumor proliferation and survival. Taletrectinib was engineered for high selectivity toward ROS1 and NTRK, improved central nervous system penetration, and activity against resistance mutations — particularly G2032R, a common cause of acquired resistance to crizotinib. This profile explains its durable responses and its ability to control brain metastases, which affect a substantial proportion of patients with advanced ROS1-positive disease.

Indications

Ibtrozi (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, as determined by an FDA-approved test. The approval is treatment-line-agnostic, covering both ROS1 TKI-naive and ROS1 TKI-pretreated patients.

Dosage

The recommended dose of Ibtrozi is 600 mg orally once daily on an empty stomach, with no food intake for at least 2 hours before and 2 hours after each dose. Since each capsule contains 200 mg, this equals three capsules taken together once daily. Treatment continues until disease progression or unacceptable toxicity. Dose modifications are managed according to the prescribing information for adverse reactions such as hepatotoxicity, interstitial lung disease, or QT prolongation.

Side Effects

The most common adverse reactions include elevated liver enzymes (AST and ALT), nausea, vomiting, anemia, diarrhea, and QT interval prolongation. More serious but less common risks include hepatotoxicity, interstitial lung disease or pneumonitis, hyperuricemia, myalgia with creatine phosphokinase elevation, and skeletal fractures. Liver function should be monitored closely, particularly during the first weeks of treatment, and patients should report any new cough, breathing difficulty, or jaundice promptly.

Storage

Store Ibtrozi capsules at room temperature in the original container, protected from moisture. Keep out of the reach of children and do not use beyond the expiry date printed on the packaging.

Why Choose the GLT?

Ibtrozi is a newly approved, first-in-class-in-its-profile therapy whose United States list price reflects both its novelty and the small, biomarker-defined population it serves. For patients and institutions seeking access to this next-generation ROS1 inhibitor, sourcing through a Hong Kong-licensed supplier such as GLT provides a verified channel with full batch documentation and transparent availability. GLT supports both the U.S.-marketed Ibtrozi and the same molecule in its China-marketed form, helping patients find the most appropriate and cost-effective option for their circumstances.

How to Order Ibtrozi (Taletrectinib)

To order Ibtrozi, contact our team on WhatsApp at +86 15234153837 or by email at [email protected]. Please share the required pack size (200 mg × 30 or × 90 capsules), quantity, and destination country so we can confirm current availability, documentation, and delivery terms.

FAQ

Is Ibtrozi the same as taletrectinib? Yes. Ibtrozi is the U.S. brand name of taletrectinib, developed by AnHeart Therapeutics and marketed in the United States by Nuvation Bio.

Is Ibtrozi the same drug as 达伯乐 (DOVBLERON)? Yes. They are the exact same molecule — taletrectinib — sold under different brand names: Ibtrozi in the United States and Japan, and 达伯乐 (DOVBLERON) in China by Innovent Biologics.

What is ROS1-positive NSCLC? It is a molecular subtype of non-small cell lung cancer driven by a ROS1 gene fusion, found in about 2% of NSCLC patients, and treated with ROS1 inhibitors such as taletrectinib.

How is Ibtrozi taken? It is taken as 600 mg (three 200 mg capsules) once daily on an empty stomach, at least 2 hours before and 2 hours after food.