Lutathera

(Lutetium Lu 177 Dotatate)

ApprovedRadiopharmaceutical

AAdvanced Accelerator Applications

Lutathera is one of 148 small molecule programs targeting Neuroendocrine Tumor. It is currently in Approved.

Indications

Total Trials

Active Trials

147

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Neuroendocrine TumorRecruiting

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationRecruiting

Metastatic Neuroendocrine TumorActive, not recruiting

High Grade GliomaRecruiting

Gastroenteropancreatic Neuroendocrine TumorActive, not recruiting

Metastatic Pancreatic Neuroendocrine TumorActive, not recruiting

ImmunotherapyRecruiting

Neuroendocrine TumorsRecruiting

Pancreatic Neuroendocrine TumorActive, not recruiting

MeningiomaRecruiting

Neuroendocrine TumorApproved

Recruiting

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationPhase 2

Recruiting

Metastatic Neuroendocrine TumorPhase 2

Active, not recruiting

High Grade GliomaPreclinical

Recruiting

Gastroenteropancreatic Neuroendocrine TumorPhase 1

Active, not recruiting

Metastatic Pancreatic Neuroendocrine TumorPhase 2

Active, not recruiting

ImmunotherapyPhase 2

Recruiting

Neuroendocrine TumorsPhase 1

Recruiting

Pancreatic Neuroendocrine TumorPhase 2

Active, not recruiting

MeningiomaPhase 2

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lutathera

AAdvanced Accelerator Applications

Approved

1 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Voltaren

Novartis

Preclinical

1 5

Zolymbus

AbbVie

Preclinical

1 6

Blenoxane

Bristol-Myers Squibb

Preclinical

1 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 9

Duragesic-100

CCephalon

Preclinical

2 10

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation

NCT05691465

Phase 2Active, not recruiting

Metastatic Neuroendocrine Tumor

NCT05724108

Phase 1Recruiting

Metastatic Pancreatic Neuroendocrine Tumor

NCT05687123

Phase 2Not yet recruiting

Breast Cancer

NCT04529044

Q1 2027

Phase 1Active, not recruiting

Metastatic Digestive System Neuroendocrine Neoplasm

NCT04234568

Q2 2027

Phase 1Active, not recruiting

Gastroenteropancreatic Neuroendocrine Tumor

NCT04609592

Clinical

Trials by Indication[1]

Metastatic Pancreatic Neuroendocrine Tumor2 trials

A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05687123·24 enrolled

Phase II Randomized, Prospective Trial of Lutetium Lu 177 Dotatate PRRT Versus Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT05247905·31 enrolled

Breast Cancer1 trial

177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer

Not yet recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT04529044·10 enrolled

Locally Advanced1 trial

Radioactive Drug (177Lu-DOTATATE) for the Treatment of Locally Advanced, Metastatic, or Unresectable Rare Endocrine Cancers

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT04106843

Immunotherapy1 trial

Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer

Recruiting·WWeill Medical College of Cornell University·Phase 2·NCT05583708·18 enrolled

Liver Metastases1 trial

Intra-arterial Lutetium-177-dotatate for Treatment of Patients With Neuro-endocrine Tumor Liver Metastases

Completed·MMarnix Lam·Phase 2/3·NCT03590119·26 enrolled

11 more indications

Meningioma1 trial

Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy

Recruiting·MMayo Clinic·Phase 2·NCT04082520·41 enrolled

Neuroendocrine Tumors1 trial

Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.

Recruiting·EEmory University·Phase 1·NCT07150546·15 enrolled

Pancreatic Neuroendocrine Tumor1 trial

Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04750954·29 enrolled

Metastatic Digestive System Neuroendocrine Neoplasm1 trial

A Phase I Trial of Triapine and Lutetium Lu 177 Dotatate in Combination for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04234568·31 enrolled

Metastatic Digestive System Neuroendocrine Tumor G11 trial

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

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05773274·100 enrolled

Advanced Lung Neuroendocrine Tumor1 trial

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

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04665739·70 enrolled

Gastroenteropancreatic Neuroendocrine Tumor1 trial

Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery

Active, not recruiting·SStanford University·Phase 1·NCT04609592·10 enrolled

Metastatic Neuroendocrine Tumor1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05724108·94 enrolled

High Grade Glioma1 trial

Phase I/II Study of Lutathera in Patients With Recurrent and/or Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET

Recruiting·NNationwide Children's Hospital·Preclinical·NCT05278208·65 enrolled

Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation1 trial

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

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05691465·35 enrolled

Neuroendocrine Tumor1 trial

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

Recruiting·VVanderbilt-Ingram Cancer Center·Approved·NCT06016855·6 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 26, 2018

LUTATHERA

NDA NDA208700

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Lutetium Lu 177 Dotatate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lutetium Lu 177 Dotatate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lutetium Lu 177 Dotatate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208700). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lutathera. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Advanced Accelerator Applications company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Radiopharmaceutical[2]
Highest Phase: Approved[1]
Company: AAdvanced Accelerator Applications

Patent Landscape[5]

Patent Cliff

Jul 25, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12168063Jul 25, 2038

12415003Jul 25, 2038

12491272Jul 25, 2038

12144873Jul 25, 2038

12151003Jul 25, 2038

13 more patents

12161732Jul 25, 2038

10596278Jul 25, 2038

10596276Jul 25, 2038

11904027Jul 25, 2038

12415003*PEDJan 25, 2039

12144873*PEDJan 25, 2039

12151003*PEDJan 25, 2039

12491272*PEDJan 25, 2039

10596278*PEDJan 25, 2039

10596276*PEDJan 25, 2039

12161732*PEDJan 25, 2039

11904027*PEDJan 25, 2039

12168063*PEDJan 25, 2039

Lutathera

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Metastatic Pancreatic Neuroendocrine Tumor2 trials

Breast Cancer1 trial

Locally Advanced1 trial

Immunotherapy1 trial

Liver Metastases1 trial

Meningioma1 trial

Neuroendocrine Tumors1 trial

Pancreatic Neuroendocrine Tumor1 trial

Metastatic Digestive System Neuroendocrine Neoplasm1 trial

Metastatic Digestive System Neuroendocrine Tumor G11 trial

Advanced Lung Neuroendocrine Tumor1 trial

Gastroenteropancreatic Neuroendocrine Tumor1 trial

Metastatic Neuroendocrine Tumor1 trial

High Grade Glioma1 trial

Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation1 trial

Neuroendocrine Tumor1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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