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177Lu-DOTA0-Tyr3-Octreotate
177Lu-DOTA0-Tyr3-Octreotate is a Radiolabeled peptide; somatostatin receptor agonist Small molecule drug developed by Advanced Accelerator Applications. It is currently in Phase 3 development for Neuroendocrine tumors (NET) with somatostatin receptor expression, Gastroenteropancreatic neuroendocrine tumors (GEP-NET). Also known as: Lutathera.
177Lu-DOTA0-Tyr3-Octreotate is a radiolabeled somatostatin analog that binds to somatostatin receptors on neuroendocrine tumor cells and delivers targeted radiation therapy.
177Lu-DOTA0-Tyr3-Octreotate is a radiolabeled somatostatin analog that binds to somatostatin receptors on neuroendocrine tumor cells and delivers targeted radiation therapy. Used for Neuroendocrine tumors (NET) with somatostatin receptor expression, Gastroenteropancreatic neuroendocrine tumors (GEP-NET).
At a glance
| Generic name | 177Lu-DOTA0-Tyr3-Octreotate |
|---|---|
| Also known as | Lutathera |
| Sponsor | Advanced Accelerator Applications |
| Drug class | Radiolabeled peptide; somatostatin receptor agonist |
| Target | Somatostatin receptor 2 (SSTR2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This drug combines octreotate, a somatostatin receptor 2 (SSTR2) agonist, with lutetium-177, a beta-emitting radioisotope. The octreotate moiety binds with high affinity to SSTR2 expressed on neuroendocrine tumor cells, allowing the attached radioactive lutetium to deliver localized cytotoxic radiation directly to tumor tissue while minimizing systemic exposure.
Approved indications
- Neuroendocrine tumors (NET) with somatostatin receptor expression
- Gastroenteropancreatic neuroendocrine tumors (GEP-NET)
Common side effects
- Nausea
- Vomiting
- Fatigue
- Bone marrow suppression
- Kidney toxicity
- Abdominal pain
Key clinical trials
- Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors (PHASE1)
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors (PHASE2)
- Targeted Therapy and Avelumab in Merkel Cell Carcinoma (PHASE1, PHASE2)
- Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial (PHASE2)
- Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors (PHASE1)
- Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells (PHASE2)
- Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors (PHASE2)
- Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- 177Lu-DOTA0-Tyr3-Octreotate CI brief — competitive landscape report
- 177Lu-DOTA0-Tyr3-Octreotate updates RSS · CI watch RSS
- Advanced Accelerator Applications portfolio CI
Frequently asked questions about 177Lu-DOTA0-Tyr3-Octreotate
What is 177Lu-DOTA0-Tyr3-Octreotate?
How does 177Lu-DOTA0-Tyr3-Octreotate work?
What is 177Lu-DOTA0-Tyr3-Octreotate used for?
Who makes 177Lu-DOTA0-Tyr3-Octreotate?
Is 177Lu-DOTA0-Tyr3-Octreotate also known as anything else?
What drug class is 177Lu-DOTA0-Tyr3-Octreotate in?
What development phase is 177Lu-DOTA0-Tyr3-Octreotate in?
What are the side effects of 177Lu-DOTA0-Tyr3-Octreotate?
What does 177Lu-DOTA0-Tyr3-Octreotate target?
Related
- Drug class: All Radiolabeled peptide; somatostatin receptor agonist drugs
- Target: All drugs targeting Somatostatin receptor 2 (SSTR2)
- Manufacturer: Advanced Accelerator Applications — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Neuroendocrine tumors (NET) with somatostatin receptor expression
- Indication: Drugs for Gastroenteropancreatic neuroendocrine tumors (GEP-NET)
- Also known as: Lutathera
- Compare: 177Lu-DOTA0-Tyr3-Octreotate vs similar drugs
- Pricing: 177Lu-DOTA0-Tyr3-Octreotate cost, discount & access