LUTATHERA (lutetium lu 177 dotatate)
Lutathera is a radiolabeled somatostatin analog used for adults and children 12 years and older who have specific types of neuroendocrine tumors. It helps patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which can occur in the foregut, midgut, or hindgut. This medication provides a targeted approach for managing these specific malignant growths.
How LUTATHERA Works
This medication works by binding to somatostatin receptors, specifically subtype 2, which are expressed on the surface of certain tumor cells. Once the drug is internalized into these cells, the lutetium-177 component releases beta-minus emissions. This process creates free radicals that cause cellular damage to both the target tumor cells and surrounding cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-01-26
- Patent Cliff
- 2039
- Revenue
- $203M (Q4-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
LUTATHERA Approval History
What LUTATHERA Treats
1 indicationsLUTATHERA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroenteropancreatic Neuroendocrine Tumors
LUTATHERA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LUTATHERA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05773274 | NCI-2023-00118 NCI-2023-00118, CCTG-NE1 | Ph 2 | recruiting | Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial |
| NCT05687123 | NCI-2022-09321 NCI-2022-09321, 202312048 | Ph 1 | recruiting | Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors |
| NCT05724108 | NCI-2023-01224 NCI-2023-01224, NCI-CIRB-10558-PMC | Ph 2 | active not recruiting | 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 |
| NCT05691465 | NCI-2022-05173 NCI-2022-05173, 10487 | Ph 2 | recruiting | Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells |
| NCT04750954 | NCI-2021-00860 NCI-2021-00860, 10450-36MTC | Ph 1 | active not recruiting | Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors |
| NCT04665739 | NCI-2020-12905 NCI-2020-12905, A021901 | Ph 2 | recruiting | Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors |
| NCT04234568 results posted | NCI-2020-00170 NCI-2020-00170, NCI-CIRB-10388-PMC | Ph 1 | active not recruiting | Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors |
| NCT05583708 iPRRT | 22-10025228 | Ph 2 | recruiting | Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer |
| NCT04082520 | MC1891 17-009927 | Ph 2 | recruiting | Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy |
| NCT03971461 | 18-00719 | Ph 2 | active not recruiting | Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma |
| NCT07150546 | STUDY00008681 P30CA138292, NCI-2025-05882 | Ph 1 | recruiting | Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors. |
| NCT04954820 ReLUTH | PROICM 2021-04 REL | Ph 2 | recruiting | Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET |
| NCT03972488 NETTER-2 results posted | CAAA601A22301 2023-507443-10-00 | Ph 3 | active not recruiting | Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET |
| NCT05987176 NELMAS | AF-ICL 01 2022-003575-42 | Ph 2 | terminated | Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases |
| NCT06016855 | VICCGI2283 NCI-2023-05914 | Ph 4 | recruiting | Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors |
| NCT04529044 | STUDY00019489 NCI-2020-04795, STUDY00019489 | Ph 2 | not yet recruiting | 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer |
| NCT04609592 | IRB-52341 NET0030, NCI-2021-03448 | Ph 1 | recruiting | Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery |
| NCT05247905 | A022001 NCI-2021-14404, U10CA180821 | Ph 2 | active not recruiting | Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors |
| NCT04614766 SPORE-3 | 202005556 P50CA174521 | Ph 1, Ph 2 | withdrawn | A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors |
| NCT04106843 | 2018-0947 NCI-2019-05859, 2018-0947 | Ph 2 | withdrawn | Radioactive Drug (177Lu-DOTATATE) for the Treatment of Locally Advanced, Metastatic, or Unresectable Rare Endocrine Cancers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LUTATHERA FDA Label Details
Indications & Usage
FDA Label (PDF)LUTATHERA is indicated for the treatment of Gastroenteropancreatic Neuroendocrine Tumors.
LUTATHERA Patents & Exclusivity
Patents (18 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LUTATHERA
Revenue Insights
- • Q4-2025: $203M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 18 active patents
Trial Analysis
- • 21 total trials
- • Stage: Growth
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment