Zurletrectinib
An investigational treatment for NTRK Fusion Cancer.
The same compound appears under different names depending on the context. Here is how to identify Zurletrectinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Zurletrectinib
- Development code
- ICP-723
- International name
- ICP-723 (China)
- Drug class
- TRK inhibitor (next generation)
- Manufacturer
- InnoCare Pharma
A next-generation oral TRK inhibitor from InnoCare, approved in China on December 11, 2025 for patients 12 and older with NTRK fusion solid tumors after an 89.1% response rate in its registrational trial. It is not approved or in active trials in the United States.
How Zurletrectinib works
Zurletrectinib blocks the TRK proteins driven by NTRK gene fusions and was built to keep binding when the solvent-front mutations that defeat first-generation drugs are present. It also crosses the blood-brain barrier. In its China trials it produced responses in patients who had never taken a TRK inhibitor and in patients whose tumors had become resistant to one.
Mechanism: Next-generation selective TRK inhibitor that crosses into the brain and stays active against solvent-front resistance mutations
Side effects and safety
InnoCare describes a good safety profile in its approval announcement but has not published side effect rates there. TRK inhibitors as a class cause on-target nervous system effects, including dizziness, weight gain, tingling or numbness and pain when the drug is stopped, and the Chinese label will carry zurletrectinib's own rates. Patients on any TRK inhibitor are monitored for liver enzyme changes.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Clinical trial results
In the registrational trial that supported Chinese approval, the overall response rate was 89.1%, the disease control rate 96.4%, and 77.4% of patients were progression-free at 24 months with 90.8% alive; InnoCare reported a 100% response rate in adolescents and in brain lesions[1]. The Phase 1/2 trial (NCT04685226, 310 patients, age 12 and older) and a Phase 2 basket trial from age 2 that includes primary brain tumors (NCT05745623) are both recruiting in China only. A US Phase 1 dose-escalation study (NCT05537987) at sites in Kansas, New York and Washington has not been updated since January 2023 and its status is listed as unknown[2]. InnoCare has not announced a US filing.
Main registered trial: NCT04685226 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Development history
InnoCare Pharma developed zurletrectinib as ICP-723. China's regulator accepted its new drug application in 2024, granted priority review in May 2025 and approved it on December 11, 2025 for adults and adolescents 12 and older with NTRK fusion solid tumors, InnoCare's first approved cancer drug for solid tumors. A second application for children aged 2 to 12 received priority review in March 2026.
Explore NTRK Fusion Cancer trials
Other NTRK Fusion Cancer treatments
Where Zurletrectinib is available
Approved outside the United States, not by the FDA
Zurletrectinib (ICP-723 (China)) has been approved by a regulator outside the United States but has no FDA approval, so it cannot be prescribed in the US. US patients can receive it only through a clinical trial that enrolls at US sites, if one exists. Check the trial record below for current sites and status.
Common questions about Zurletrectinib
▸What is Zurletrectinib?
A next-generation oral TRK inhibitor from InnoCare, approved in China on December 11, 2025 for patients 12 and older with NTRK fusion solid tumors after an 89.1% response rate in its registrational trial. It is not approved or in active trials in the United States.
▸How does Zurletrectinib work?
Zurletrectinib blocks the TRK proteins driven by NTRK gene fusions and was built to keep binding when the solvent-front mutations that defeat first-generation drugs are present. It also crosses the blood-brain barrier. In its China trials it produced responses in patients who had never taken a TRK inhibitor and in patients whose tumors had become resistant to one.
▸What are the side effects of Zurletrectinib?
InnoCare describes a good safety profile in its approval announcement but has not published side effect rates there. TRK inhibitors as a class cause on-target nervous system effects, including dizziness, weight gain, tingling or numbness and pain when the drug is stopped, and the Chinese label will carry zurletrectinib's own rates. Patients on any TRK inhibitor are monitored for liver enzyme changes.
▸Is Zurletrectinib FDA approved?
Zurletrectinib is currently in phase 2 clinical trials for NTRK Fusion Cancer. It has not yet received FDA approval.
▸Is zurletrectinib approved in the United States?
No. It was approved in China on December 11, 2025 for patients 12 and older with NTRK fusion solid tumors. InnoCare has not announced a US application, and the only US trial, a Phase 1 dose-escalation study, has not been updated since January 2023.
▸How effective is zurletrectinib?
In the registrational trial reported by InnoCare, 89.1% of patients responded, 96.4% had disease control, and 77.4% were progression-free at 24 months. Those figures come from a single-arm China trial and have not been compared head to head with Vitrakvi, Rozlytrek or Augtyro.
▸Does zurletrectinib work after Vitrakvi or Rozlytrek fails?
InnoCare reports that it overcame acquired resistance to first-generation TRK inhibitors in its trials, consistent with its design against solvent-front mutations. The published numbers for that subgroup are limited to the company's announcements.
▸Can US patients get zurletrectinib?
Not outside China. The 2 recruiting trials (NCT04685226 and NCT05745623) are at Chinese sites only. US patients whose tumors have become resistant to a first-generation drug have Augtyro (repotrectinib) as the approved option.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- InnoCare Pharma · 2025-12-11. InnoCare announces approval of the next-generation TRK inhibitor zurletrectinib in China. https://www.innocarepharma.com/en/news/activity/en020251211-Approval-of-Next-Generation-TRK-Inhibitor-Zurletrectinib-in-China
- ClinicalTrials.gov. A study of ICP-723 in patients with advanced solid tumors. https://clinicaltrials.gov/study/NCT04685226
- British Journal of Cancer · 2024-06-14. Zurletrectinib (ICP-723), a next-generation pan-TRK inhibitor, in TRK fusion-positive solid tumors. https://www.nature.com/articles/s41416-024-02760-1