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Drug

lutetium Lu 177 dotatate

Approved · EMA
ClassSomatostatin receptor binding agentEmerging researchLate-stage development
Also known as (177Lu-DOTAOTyr3)Octreotate, 177 Lu-DOTA-TATE, 177 Lu-DOTA-octreotate, 177Lu Dotatate+17 more

(177Lu-DOTAOTyr3)Octreotate, 177 Lu-DOTA-TATE, 177 Lu-DOTA-octreotate, 177Lu Dotatate, 177Lu-DOTA-TATE, 177Lu-DOTA-Tyr3-octreotate, 177Lu-DOTA-octreotate, 177Lu-DOTA0-Tyr3-Octreotate, 177Lu-dotatate, 177LuDOTA-TATE, Dotatate lutenium Lu-177, LUTETIUM DOTATATE,LU-177, LUTETIUM DOTATE,LU-177, LUTETIUM OXODOTREOTIDE LU-177, Lu-177-DOTATATE, Lu-DOTA-TATE, Lu-DOTATATE, Lu177-DOTATATE, Lutathera, Lutetium (177Lu) Oxodotreotide, Lutetium dotatate Lu-177.

RxNorm1999335ChEMBLCHEMBL4297545ATCV10XX04UNIIAE221IM3BB
1
Research papers
26
Active clinical trials
5
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

NET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus or Sunitinib or Cabozantinib in Metastatic/Unresectable Gastroenteropancreatic Neuroendocrine Tumours

Clinical trial2026-07-28Results expected Q2 2029 · ClinicalTrials.gov

A Phase I, Open-label, Multi-center Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

Clinical trial2026-07-10Results expected Q3 2026 · ClinicalTrials.gov

Phase I/II Study of Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

Clinical trial2026-07-09Results expected Q3 2027 · ClinicalTrials.gov

Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors

Clinical trial2026-07-09Results expected Q3 2027 · ClinicalTrials.gov

A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer With Neuroendocrine Differentiation

Clinical trial2026-07-06Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors

Clinical trial2026-07-02Results expected Q4 2026 · ClinicalTrials.gov

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

Clinical trial2026-06-24Results expected Q2 2027 · ClinicalTrials.gov

177Lu-DOTATATE for Recurrent Meningioma: a Randomized Phase II Study

Clinical trial2026-06-15Results expected Q2 2027 · ClinicalTrials.gov

A Phase 1b Trial of M3814 (Peposertib) in Combination With Lutetium 177 Dotatate for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Clinical trial2026-06-15Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer

Clinical trial2026-06-05Results expected Q4 2027 · ClinicalTrials.gov

Approval: Lutathera (EMA)

Regulatory2017-09-26EMA

Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival.

Research2008-05-01Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
lutetium Lu 177 dotatate
Aliases & brands
(177Lu-DOTAOTyr3)Octreotate177 Lu-DOTA-TATE177 Lu-DOTA-octreotate177Lu Dotatate177Lu-DOTA-TATE177Lu-DOTA-Tyr3-octreotate177Lu-DOTA-octreotate177Lu-DOTA0-Tyr3-Octreotate177Lu-dotatate177LuDOTA-TATEDotatate lutenium Lu-177LUTETIUM DOTATATE,LU-177LUTETIUM DOTATE,LU-177LUTETIUM OXODOTREOTIDE LU-177Lu-177-DOTATATELu-DOTA-TATELu-DOTATATELu177-DOTATATELutatheraLutetium (177Lu) OxodotreotideLutetium dotatate Lu-177
RxNorm CUI
1999335
ChEMBL ID
CHEMBL4297545
ATC codes
V10XX04
UNII
AE221IM3BB
Primary mechanism
Somatostatin receptor binding agent
Regulatory jurisdictions
ema

Pharmacology & targets

5 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Somatostatin receptor type 5
SSTR5 · P35346
BINDING AGENTSomatostatin receptor binding agent
Somatostatin receptor type 2
SSTR2 · P30874
BINDING AGENTSomatostatin receptor binding agent
Somatostatin receptor type 4
SSTR4 · P31391
BINDING AGENTSomatostatin receptor binding agent
Somatostatin receptor type 1
SSTR1 · P30872
BINDING AGENTSomatostatin receptor binding agent
Somatostatin receptor type 3
SSTR3 · P32745
BINDING AGENTSomatostatin receptor binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-09-26
Latest approval
2017-09-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2017-09-26Approval
Approval: Lutathera (EMA)
Indication: Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic… Show full indication

Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP?NETs) in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

42 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
42
registered trials across all phases
LATEST COMPLETION 2026
26
Active studies
16
Recruiting
7
Late-stage (III+)
7
Completed
9
Discontinued
PHASE DISTRIBUTIONn = 42
Early Phase 11Phase 19Phase 1 / 24Phase 221Phase 2 / 31Phase 35Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

RecruitingPH IVVanderbilt-Ingram Cancer Centern=62028

A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 <10%) Advanced GEP-NET With High Disease Burden (NETTER-3)

RecruitingPH IIINovartis Pharmaceuticalsn=2402034

A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Somatostatin Receptor Positive Neuroendocrine Neoplasms

Active, not recruitingPH II/IIISinotau Pharmaceutical Groupn=742029

A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With Inoperable, Progressive, Well Differentiated, Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumours

Active, not recruitingPH IIISinotau Pharmaceutical Groupn=1962028

Compare the Safety and Efficacy of 177Lu-DOTATATE and Octreotide LAR in Unresectable or Metastatic, Progressive, Well-differentiated(G1 and G2) and SSTR-positive Adult GEP-NEN

RecruitingPH IIIHTA Co., Ltd.n=1842027

Recent completions

Trials that read out recently, adding to the completed evidence base.

Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate

CompletedPH IUniversity of Wisconsin, Madisonn=42026

Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II.

CompletedPH IIGustave Roussy, Cancer Campus, Grand Parisn=842024

A Prospective Phase II Single-Arm Trial on Neoadjuvant Peptide Receptor Radionuclide Therapy With 177Lu-DOTATATE Followed by Surgery for Resectable Pancreatic Neuroendocrine Tumors

CompletedPH IIIRCCS San Raffaelen=312023

A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

CompletedPH IIIAdvanced Accelerator Applicationsn=2312021

Phase I/II Trial of Anti-PD-1 Checkpoint Inhibitor Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer

CompletedPH I/IIGeorgetown Universityn=92020

A Multicenter Phase II-Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors

CompletedPH IILund University Hospitaln=602018

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2008 · 1,022 cites
Recent papers

Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2008 · 1,022 cites
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • de Herder WW1
  • Feelders RA1
  • Kam BL1
  • Kooij PP1
  • Krenning EP1
  • Kwekkeboom DJ1
  • van Aken MO1
  • van Eijck CH1
Leading institutions
free-text, unnormalised
  • Erasmus Medical Center1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Octreotide

Studied across 7 of the same disease areas as lutetium Lu 177 dotatate in the shared literature.

7 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.