Lutetium Lu-177 DOTATATE
Also referenced as: Lutathera
A peptide-targeted radionuclide therapy for somatostatin-receptor-positive neuroendocrine tumors.
- Evidence grade
- AStrong Clinical Evidence
Strong Clinical Evidence
- Regulatory status
- FDA Approved for Specific Indication
Lutathera is FDA-approved for SSTR-positive GEP-NETs in adults and children aged 12 years and older.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
A peptide-targeted radionuclide therapy for somatostatin-receptor-positive neuroendocrine tumors.
Lutathera is FDA-approved for SSTR-positive GEP-NETs in adults and children aged 12 years and older.
Specialist radiation handling and monitoring are integral to care. Imaging with Ga-68 DOTATATE is not the same treatment.
Why It's Being Studied
- Gastroenteropancreatic neuroendocrine tumors
- Peptide receptor radionuclide therapy
Mechanism of Action
The somatostatin-receptor-binding peptide delivers lutetium-177 beta radiation to receptor-expressing tissue.
The somatostatin-receptor-binding peptide delivers lutetium-177 beta radiation to receptor-expressing tissue. Specialist radiation handling and monitoring are integral to care. Imaging with Ga-68 DOTATATE is not the same treatment.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- Gastroenteropancreatic neuroendocrine tumors
- Peptide receptor radionuclide therapy
- Intravenous therapeutic radiopharmaceutical
Evidence Summary
NETTER-1 supports progression-free-survival benefit in its studied neuroendocrine tumor population.
Higher tiers carry more weight. Filled tiers have evidence for Lutetium Lu-177 DOTATATE; tap to read it.
- NETTER-1 supports progression-free-survival benefit in its studied neuroendocrine tumor population.
1 cited sources.
- Prescribing label1
Human clinical evidence
- NETTER-1 supports progression-free-survival benefit in its studied neuroendocrine tumor population.
Reported Adverse Events in Research
- Risks include bone-marrow suppression, secondary myelodysplastic syndrome or leukemia, kidney or liver toxicity and reproductive harm.
Limitations of Current Evidence
- Specialist radiation handling and monitoring are integral to care. Imaging with Ga-68 DOTATATE is not the same treatment.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Lutetium Lu-177 DOTATATE | Trofinetide | |
|---|---|---|
| Evidence grade | A — Strong Clinical Evidence | B — Moderate Human Evidence |
| Regulatory status | FDA Approved for Specific Indication | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Intravenous therapeutic radiopharmaceutical | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Prescribing label
Lutetium Lu-177 DOTATATE — prescribing label