Lutetium Lu 177 Dotatate is named as an intervention in 2 current clinical trials in our Canada and Mexico registers. 2 are recruiting patients now. The most common phase is Phase 1. The lead sponsor is National Cancer Institute (NCI). The most-studied condition is Metastatic Pancreatic Neuroendocrine Tumor.
Of the three regulators tracked here, the first to approve Lutetium Lu 177 Dotatate was the US, on 26 Jan 2018.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Protections still running for marketed products containing Lutetium Lu 177 Dotatate, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
NCT05773274 · ClinicalTrials.gov ↗ · Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Digestive System Neuroendocrine Tumor G2, Unresectable Digestive System Neuroendocrine Tumor G1
|
Phase 2 | Recruiting | National Cancer Institute (NCI) | Canada, Mexico |
|
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
NCT05687123 · ClinicalTrials.gov ↗ · Metastatic Pancreatic Neuroendocrine Tumor, Pancreatic Neoplasm, Stage III Pancreatic Neuroendocrine Tumor AJCC v8
|
Phase 1 | Recruiting | National Cancer Institute (NCI) | Canada |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
| Lead sponsor | Trials |
|---|---|
| National Cancer Institute (NCI) | 2 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in Canada | 2 | 2 |
| Clinical trials in Mexico | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
2 current trials in our Canada and Mexico registers name Lutetium Lu 177 Dotatate (also registered as 177 Lu-DOTA-TATE) as a drug or biological intervention, as of the registry sync on 28 September 2026. Completed and withdrawn studies are not counted.
Yes. 2 of the 2 trials are recruiting: 2 with sites in Canada and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
The lead sponsor is National Cancer Institute (NCI). The number in brackets is how many trials each organisation leads.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Lutetium Lu 177 Dotatate works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Lutetium Lu 177 Dotatate works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Lutetium Lu 177 Dotatate (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 28 Sep 2026.