Lutathera

Phase 3Small molecule

Novartis

Lutathera is one of 114 small molecule programs targeting Meningioma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

113

Competitors

Pipeline

Status by Indication[3][1]

Indication

MeningiomaActive, not recruiting

TreatmentRecruiting

Gastroenteropancreatic Neuroendocrine TumorActive, not recruiting

High Grade GliomaRecruiting

Efficacy and SafetyActive, not recruiting

MeningiomaPhase 2

Active, not recruiting

TreatmentPhase 2

Recruiting

Gastroenteropancreatic Neuroendocrine TumorPhase 1

Active, not recruiting

High Grade GliomaPreclinical

Recruiting

Efficacy and SafetyPhase 3

Active, not recruiting

Competition

Competitive Landscape

332 competitors in Treatment

#DrugCompanyPhaseTrials

Lutathera

Novartis

Phase 3

1 2

Biltricide

Bayer

Preclinical

3 3

Theo-Dur

Pfizer

Preclinical

1 4

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 5

Lamprene

Novartis

Preclinical

1 6

Niclocide

Bayer

Preclinical

1 7

Minipress

Pfizer

Preclinical

1 8

Foscavir

CClinigen, Inc.

Preclinical

6 9

Reminyl

WWim Janssens

Preclinical

1 10

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Meningioma

NCT03971461

Q2 2027

Phase 1Active, not recruiting

Gastroenteropancreatic Neuroendocrine Tumor

NCT04609592

Q3 2027

Active, not recruiting

Study completion

NCT03691064

Q4 2027

Phase 3Active, not recruiting

Efficacy and Safety

NCT03972488

Clinical

Trials by Indication[1]

Heart Disease1 trial

Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy

Unknown status·KKing's College Hospital NHS Trust·Phase 2·NCT04039516·20 enrolled

Efficacy and Safety1 trial

Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET

Active, not recruiting·AAdvanced Accelerator Applications·Phase 3·NCT03972488·226 enrolled

Observational Study1 trial

Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

Active, not recruiting· Novartis logo

Novartis··NCT04727723·164 enrolled

Adjuvant Treatment1 trial

Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases

Terminated·IImperial College London·Phase 2·NCT05987176·1 enrolled

Treatment1 trial

Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET

Recruiting·IInstitut du Cancer de Montpellier - Val d'Aurelle·Phase 2·NCT04954820·146 enrolled

6 more indications

Biomarker1 trial

Biomarker Identification of Radionuclide Therapy-induced Radiation Responses

Unknown status·EErasmus Medical Center·N/A·NCT05513469·20 enrolled

Neuroendocrine Tumors1 trial

A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors

Withdrawn·DDavid Bushnell·Phase 1/2·NCT04614766

Meningioma1 trial

A Single Arm, Open-label, Multicenter Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma

Active, not recruiting·NNYU Langone Health·Phase 2·NCT03971461·32 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

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

Unspecified1 trial

Post-Authorization Long-Term Safety Study of LUTATHERA

Active, not recruiting·AAdvanced Accelerator Applications··NCT03691064·1,014 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Lutathera. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lutathera compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lutathera. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

Lutathera

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Heart Disease1 trial

Efficacy and Safety1 trial

Observational Study1 trial

Adjuvant Treatment1 trial

Treatment1 trial

Biomarker1 trial

Neuroendocrine Tumors1 trial

Meningioma1 trial

Gastroenteropancreatic Neuroendocrine Tumor1 trial

High Grade Glioma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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