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IndexedBuilt automatically from public databases on 2026-09-30. Not yet hand-reviewed by PLOBT.How this works →

Lutetium Lu 177 dotatate

FDA approved · Rx

Radioligand peptide therapy

Also known as: Lutathera, 177Lu-dotatate, Lutetium dotatate lu-177, 177Lu-DOTA-Tyr3-octreotate, (177)lu-dotatate, Lutetium oxodotreotide lu-177, Dotatate lutetium lu-177

Evidence score
95/ 100
Strong evidence

Strong, human-grade evidence

  • Regulatory standing. FDA-approved prescription medicine
  • Human trials. Backed by controlled human studies
  • Registered human trials. 98 registered studies on ClinicalTrials.gov, most advanced Phase 4
  • 2 cited sources. Includes primary / regulatory sources

Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.

What it is

Lutetium Lu 177 dotatate is a radioactive drug made by attaching the isotope lutetium-177 to a synthetic peptide that resembles somatostatin. The peptide binds to somatostatin receptors, which are found in high numbers on certain neuroendocrine tumor cells, and the attached isotope delivers radiation directly to those cells.

What the evidence shows

Automatic summaryHuman trials

It is FDA-approved, sold as Lutathera, for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, supported by randomized trials and about 100 registered human studies reaching Phase 4. Its use outside approved indications is still being studied and is less established.

Key facts

Molecular formula
C65H87LuN14O19S2
Molecular weight
1609.5 g/mol
FDA approval
Confirmed on openFDA

Registered human trials

Live from ClinicalTrials.gov, refreshed daily.

98registered studies
Phase 4most advanced phase
26completed (sample)
33recruiting (sample)

LUTATHERA Injection General Use Result Survey

CompletedNCT05844332

Comparing 177Lu-Dotatate/Capecitabine Combination Treatment With 177Lu-Dotatate in Neuroendocrine Tumor Patients

Phase 2TerminatedNCT07012330

A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors

Phase 2WithdrawnNCT04614766

Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy

Phase 2UnknownNCT04039516

Published literature

Live from Europe PMC. This is how much has been published, not how much is proven in humans.

16papers referencing Lutetium Lu 177 dotatate

The role of baseline Ga-68 DOTATATE positron emission tomography/computed tomography in the prediction of response to fixed-dose peptide receptor radionuclide therapy with Lu-177 DOTATATE.

Turk J Med Sci2016

Efficacy of <sup>177</sup>Lu-Dotatate Therapy in the Treatment of Recurrent Meningioma.

Mayo Clin Proc Innov Qual Outcomes2021

Lutetium Lu-177 Dotatate Flare Reaction.

Adv Radiat Oncol2021

Lutetium Lu 177 Dotatate Approved by FDA.

Cancer Discov2018

Sources

Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.