Lutetium Lu-177 dotatate (Lutathera)

Also known as: 177Lu-DOTATATE · Lu-177-DOTATATE · 177Lu-DOTA-TATE · lutetium Lu 177 dotatate

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 3 applications
Randomized controlled trials 4 of 641 publications on PubMed
Registered clinical trials 105 53 active
Adverse event reports 5,697 2,349 classified as serious
  • Lutetium Lu-177 dotatate (Lutathera) is an FDA-approved drug, marketed as Lutathera, Bexlutry, Bravnetsa (first approval: January 26, 2018).
  • PubMed lists 641 publications mentioning it, including 4 randomized controlled trials and 4 animal-only studies.
  • ClinicalTrials.gov lists 105 registered studies testing it (53 active).
  • FDA's adverse event system (FAERS) holds 5,697 reports mentioning it; 2,349 classified as serious. Reports do not prove causation.

Research topics

  • Octreotide 96
  • Organometallic Compounds 90
  • Neuroendocrine Tumors 74
  • Radiopharmaceuticals 64
  • Radioisotopes 26
  • Receptors, Peptide 26
  • Pancreatic Neoplasms 25
  • Intestinal Neoplasms 21
  • Single Photon Emission Computed Tomography Computed Tomography 20
  • Radiometry 19

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA208700 LUTATHERA Approved, marketed January 26, 2018 AAA USA INC
NDA218525 BEXLUTRY Approved, marketed September 14, 2026 CURIUM
ANDA217060 BRAVNETSA Approved, marketed September 21, 2026 LANTHEUS MEDICAL

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 641
  • Human (MeSH) 448
  • Animal only 4
  • Clinical trials 30
  • Randomized controlled trials 4
  • Systematic reviews & meta-analyses 13
  • Case reports 118
  • Retracted 1

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
105
Active
53
With posted results
8

Conditions studied

  • Neuroendocrine Tumors 39
  • Gastroenteropancreatic Neuroendocrine Tumor 5
  • Meningioma 5
  • Paraganglioma 4
  • Pheochromocytoma 4
  • Liver Metastases 4
  • Metastatic Pancreatic Neuroendocrine Tumor 3
  • Gastroenteropancreatic Neuroendocrine Tumors 3
  • Neuroendocrine Neoplasm 3
  • Gastro-enteropancreatic Neuroendocrine Tumor 3
  • Unresectable Digestive System Neuroendocrine Tumor G1 2
  • Unresectable Digestive System Neuroendocrine Tumor G2 2
Study Status Phase Start
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
NCT04529044 OHSU Knight Cancer Institute
Recruiting Phase 2 June 30, 2026
A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
NCT07635316 Novartis Pharmaceuticals
Recruiting — June 12, 2026
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
NCT07150546 Emory University
Recruiting Phase 1 October 14, 2025
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment
NCT06955169 RTOG Foundation, Inc.
Recruiting Phase 2 August 24, 2025
Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
NCT06878664 Grupo Espanol de Tumores Neuroendocrinos
Recruiting Phase 3 June 12, 2025
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
NCT06784752 Novartis Pharmaceuticals
Recruiting Phase 3 May 30, 2025
177Lu-DOTATATE for Recurrent Meningioma
NCT06326190 European Organisation for Research and Treatment of Cancer - EORTC
Recruiting Phase 2 March 10, 2025
SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization
NCT06389097 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting — February 3, 2025
Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors
NCT06663072 University of Chicago
Recruiting Phase 1 December 13, 2024
Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial
NCT06126588 Central Hospital, Nancy, France
Recruiting Phase 2 November 29, 2024
Show 40 more studies
Study Status Phase Start
Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).
NCT06607692 Fundación de investigación HM
Recruiting Phase 1, Phase 2 September 20, 2024
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
NCT05687123 National Cancer Institute (NCI)
Recruiting Phase 1 August 14, 2024
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
NCT06379217 Novartis Pharmaceuticals
Active, not recruiting Phase 1 July 29, 2024
A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms
NCT06398444 Sinotau Pharmaceutical Group
Recruiting Phase 2, Phase 3 June 11, 2024
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
NCT06016855 Vanderbilt-Ingram Cancer Center
Recruiting Phase 4 May 31, 2024
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
NCT06395402 University of Iowa
Recruiting Phase 2 May 3, 2024
Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
NCT06256705 Assistance Publique - Hôpitaux de Paris
Recruiting N/A March 25, 2024
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
NCT05773274 National Cancer Institute (NCI)
Recruiting Phase 2 January 12, 2024
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
NCT05691465 National Cancer Institute (NCI)
Recruiting Phase 2 December 27, 2023
Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications
NCT06121271 University College, London
Not yet recruiting Phase 2 December 18, 2023
A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs
NCT07057622 HTA Co., Ltd.
Recruiting Phase 3 December 12, 2023
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
NCT05724108 National Cancer Institute (NCI)
Active, not recruiting Phase 2 August 30, 2023
Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer
NCT05583708 Weill Medical College of Cornell University
Recruiting Phase 2 August 3, 2023
Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors, the ComPareNET Trial
NCT05247905 Alliance for Clinical Trials in Oncology
Active, not recruiting Phase 2 February 16, 2023
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
NCT04665739 National Cancer Institute (NCI)
Recruiting Phase 2 February 3, 2023
Study of Cabozantinib With Lu-177 in Patients With Somatostatin Receptor 2 Positive Neuroendocrine Tumors
NCT05249114 Providence Health & Services
Active, not recruiting Phase 1 December 28, 2022
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
NCT05278208 Nationwide Children's Hospital
Recruiting Phase 1, Phase 2 November 21, 2022
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
NCT04086485 National Cancer Institute (NCI)
Recruiting Phase 1, Phase 2 October 3, 2022
Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
NCT04711135 Advanced Accelerator Applications Results posted
Active, not recruiting Phase 2 August 31, 2022
A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs
NCT05459844 Sinotau Pharmaceutical Group
Active, not recruiting Phase 3 August 31, 2022
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
NCT05142696 Novartis Pharmaceuticals
Active, not recruiting Phase 1, Phase 2 July 13, 2022
Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors
NCT05870423 Erasmus Medical Center
Recruiting Phase 1 June 1, 2022
A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent.
NCT05109728 Novartis Pharmaceuticals
Active, not recruiting Phase 1 May 10, 2022
Lutathera and ASTX727 in Neuroendocrine Tumours
NCT05178693 Imperial College London
Recruiting Phase 1 April 25, 2022
PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours
NCT05053854 Peter MacCallum Cancer Centre, Australia
Recruiting Phase 1 December 8, 2021
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
NCT04954820 Institut du Cancer de Montpellier - Val d'Aurelle
Recruiting Phase 2 October 18, 2021
Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
NCT04837885 University Hospital, Bordeaux
Recruiting Phase 2 September 24, 2021
Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors
NCT04750954 National Cancer Institute (NCI)
Active, not recruiting Phase 1 July 22, 2021
177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
NCT04903899 Jakob Stenman
Recruiting Phase 2 May 19, 2021
Spanish Series of Patients Treated With the Radionuclide Lutetium177
NCT04949282 Sociedad Española de Medicina Nuclear e Imagen Molecular
Recruiting — May 10, 2021
Study of PRRT in Metastatic, WHO Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
NCT04609592 Stanford University
Active, not recruiting Phase 1 March 17, 2021
Targeted Therapy and Avelumab in Merkel Cell Carcinoma
NCT04261855 Melanoma and Skin Cancer Trials Limited
Active, not recruiting Phase 1, Phase 2 October 8, 2020
Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver
NCT04544098 Memorial Sloan Kettering Cancer Center
Active, not recruiting Early phase 1 September 2, 2020
Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors
NCT04234568 National Cancer Institute (NCI) Results posted
Active, not recruiting Phase 1 July 20, 2020
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
NCT04082520 Mayo Clinic
Recruiting Phase 2 April 14, 2020
Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients
NCT04917484 Tine Gregersen, MD
Recruiting Phase 2 February 1, 2020
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
NCT03972488 Advanced Accelerator Applications Results posted
Active, not recruiting Phase 3 January 8, 2020
PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)
NCT07185672 Tata Memorial Hospital
Recruiting Phase 3 August 7, 2019
Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
NCT03971461 NYU Langone Health
Active, not recruiting Phase 2 May 15, 2019
Post-Authorization Long-Term Safety Study of LUTATHERA
NCT03691064 Advanced Accelerator Applications
Active, not recruiting — November 28, 2018

All 105 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
5,697
Serious
2,349
With death outcome
707

Most reported reactions

  • Ill-defined disorder 1,541
  • General physical health deterioration 1,200
  • Death 439
  • Malignant neoplasm progression 351
  • Nausea 235
  • Platelet count decreased 229
  • Covid-19 198
  • Fatigue 195
  • Diarrhoea 186
  • Disease progression 174
  • Laboratory test abnormal 172
  • Illness 166

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • Lutathera HUMAN PRESCRIPTION DRUG Advanced Accelerator Applications USA, Inc January 15, 2026

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.