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Legal status · United States

Is Telaglenastat legal in the United States?

Written by Reviewed Sep 2026

Not approvedLongevityHuman studies cited: 5

Direct answer

No. Telaglenastat is not approved for any medical use in the United States; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 5 human studies are cited on its profile.

Telaglenastat in the United States at a glance

ClassificationInvestigational, not approved
FDA approval statusNot approved for any indication. Investigational; the pivotal randomised phase 2 in renal cell carcinoma missed its primary endpoint in 2022 and several later company trials were terminated. No ageing or senescence indication is registered.
Human studies cited5 of 6 citations on the profile
ReviewedSep 2026

Classification and note come from the Telaglenastat profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.

What this means

  • 01

    Telaglenastat is being studied in registered clinical trials but has not received FDA marketing approval in the United States.

  • 02

    Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.

  • 03

    Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.

What Telaglenastat is

The only glutaminase inhibitor with randomised human data, and the data are oncology. Its pivotal trial in 444 patients with kidney cancer found median progression-free survival of 9.2 months against 9.3 on placebo. It has never been tested for senescence in a person.

Telaglenastat is an orally bioavailable, selective inhibitor of glutaminase 1, the enzyme that converts glutamine to glutamate. It matters to this catalogue because glutaminase inhibition is a senolytic mechanism in mice: senescent cells depend on glutaminolysis to buffer the acidity caused by lysosomal damage, and blocking it kills them.

Mechanism: Established in humans as pharmacology and in mice as senolysis, and these should not be merged. In people, telaglenastat blocks glutaminase 1, reducing the tumour's ability to use glutamine for biosynthesis; this was the rationale for combining it with cabozantinib and everolimus.

Regulatory history: Not approved for any indication. Investigational; the pivotal randomised phase 2 in renal cell carcinoma missed its primary endpoint in 2022 and several later company trials were terminated. No ageing or senescence indication is registered.

How FDA treats this kind of product

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Telaglenastat at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.

Telaglenastat in other countries

Frequently asked questions

Is Telaglenastat legal in the United States?

No. Telaglenastat is not approved for any medical use in the United States; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 5 human studies are cited on its profile.

Can I buy Telaglenastat in the United States?

No approved product exists to buy. In the United States Telaglenastat is classified as "Investigational, not approved", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors.

Is Telaglenastat FDA approved?

No. FDA status: Not approved for any indication. Investigational; the pivotal randomised phase 2 in renal cell carcinoma missed its primary endpoint in 2022 and several later company trials were terminated. No ageing or senescence indication is registered.. Current US classification: "Investigational, not approved". On the evidence, 5 human studies are cited on its profile.

Related compounds in the United States

Full research profile

Mechanism, cited studies, FDA status and the full legal summary for Telaglenastat live on its compound profile.

Telaglenastat profile

This page is general information about the regulatory status of Telaglenastat in the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug Administration directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.