TL118
An investigational treatment for NTRK Fusion Cancer.
The same compound appears under different names depending on the context. Here is how to identify TL118 wherever you encounter it, plus the key facts at a glance.
- Generic name
- TL118
- Development codes
- TL118, TL-118
- Drug class
- TRK inhibitor (investigational)
- Manufacturer
- Teligene
An investigational oral pan-TRK inhibitor from Teligene in a Phase 2 trial for adults with NTRK fusion solid tumors. It is one of only 2 investigational NTRK drugs recruiting at US sites as of October 2026. No efficacy results have been published.
How TL118 works
TL118 is designed to block the TRKA, TRKB and TRKC proteins that an NTRK gene fusion keeps permanently switched on, the same target as Vitrakvi, Rozlytrek and Augtyro. Teligene has not published how it differs structurally from the approved drugs or whether it is active against resistance mutations, so what it adds will not be known until trial results are released.
Mechanism: Oral inhibitor of all 3 TRK proteins (TRKA, TRKB, TRKC)
Side effects and safety
No safety results from the Phase 2 trial have been published. TRK inhibitors as a class cause on-target nervous system effects such as dizziness, weight gain, tingling or numbness and pain when the drug is stopped, and liver enzyme changes are monitored, so the trial will track those.
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
The Phase 2 trial (NCT06010342) is enrolling 60 adults with solid tumors that carry an NTRK gene fusion, with overall response rate as the primary endpoint. It started in March 2023, is recruiting at MD Anderson in Houston, Texas Oncology in Dallas and Adventist Health in Glendale, California, as well as sites in China, and lists December 2027 for primary completion[1]. No results have been presented or published as of October 2026.
Development history
TL118 is developed by Teligene, a small company with operations in the United States and China. Its Phase 2 NTRK trial was registered in August 2023 and has been recruiting since.
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Where to access TL118
Investigational: available only through clinical trial enrollment
TL118 has not been approved by the FDA and is not available by prescription. The only way for a patient to receive TL118 today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with the specialist who manages the patient's condition and knows their current treatment.
Primary active trial
ClinicalTrials.gov record NCT06010342
View full trial record on ClinicalTrials.gov →Trial status, site list, and eligibility are pulled from ClinicalTrials.gov. Confirm current recruitment status and nearest site directly with the study team before traveling.
Common questions about TL118
▸What is TL118?
An investigational oral pan-TRK inhibitor from Teligene in a Phase 2 trial for adults with NTRK fusion solid tumors. It is one of only 2 investigational NTRK drugs recruiting at US sites as of October 2026. No efficacy results have been published.
▸How does TL118 work?
TL118 is designed to block the TRKA, TRKB and TRKC proteins that an NTRK gene fusion keeps permanently switched on, the same target as Vitrakvi, Rozlytrek and Augtyro. Teligene has not published how it differs structurally from the approved drugs or whether it is active against resistance mutations, so what it adds will not be known until trial results are released.
▸What are the side effects of TL118?
No safety results from the Phase 2 trial have been published. TRK inhibitors as a class cause on-target nervous system effects such as dizziness, weight gain, tingling or numbness and pain when the drug is stopped, and liver enzyme changes are monitored, so the trial will track those.
▸Is TL118 FDA approved?
TL118 is currently in phase 2 clinical trials for NTRK Fusion Cancer. It has not yet received FDA approval.
▸Is TL118 available to patients?
Only through its Phase 2 trial (NCT06010342), which is recruiting adults with NTRK fusion solid tumors at MD Anderson in Houston, Texas Oncology in Dallas and Adventist Health in Glendale, California, plus sites in China. It is not approved anywhere.
▸Has TL118 shown results in NTRK fusion cancer?
No results have been published or presented as of October 2026. The trial's primary endpoint is overall response rate, and primary completion is listed for December 2027.
▸How is TL118 different from Vitrakvi and Augtyro?
Teligene describes it as an oral pan-TRK inhibitor, the same target as the approved drugs, but has not published structural details or data on resistance mutations. Whether it offers something new, such as activity after a prior TRK inhibitor, will depend on the Phase 2 results.
▸Who can join the TL118 trial?
Adults with a solid tumor that has an NTRK gene fusion confirmed by testing. The full eligibility criteria, including rules about prior TRK inhibitor treatment, are on the ClinicalTrials.gov record for NCT06010342.
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.
- ClinicalTrials.gov. A Phase 2 study of TL118 in patients with solid tumors harboring NTRK gene fusions. https://clinicaltrials.gov/study/NCT06010342