Lutetium
US-FDASourced from openFDA
GET
/api/v1/drug/lutetiumApproval history
Sourced from openFDA- Jan 26, 2018NDANDA208700Aaa Usa Inc
- Mar 23, 2022NDANDA215833Novartis
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
17,889 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1General Physical Health Deterioration6,71738%
- 2Ill-defined Disorder5,15929%
- 3Death1,6909.4%
- 4Malignant Neoplasm Progression6323.5%
- 5Disease Progression4962.8%
- 6Laboratory Test Abnormal4192.3%
- 7Fatigue4122.3%
- 8Platelet Count Decreased3762.1%
- 9Nausea3552.0%
- 10Covid-193381.9%
- 11Illness3171.8%
- 12Anaemia2771.5%
- 13Thrombocytopenia2581.4%
- 14Prostatic Specific Antigen Increased2551.4%
- 15Malaise2531.4%
Literature
Recent PubMed references pinned to Lutetium as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Sudden Diffuse Hepatic Metastases After First 177Lu-PSMA Cycle in Bone Predominant mCRPC Patient.Clinical nuclear medicine · 2026 · Samadi MH, Forouzanian S, Sahafi P, et al.PMID 42247620DOI 10.1097/RLU.0000000000006170
- Preclinical evaluation of (89)Zr/(177)Lu/(161)Tb-labeled anti-CD228 monoclonal antibody for theranostics in skin cutaneous melanoma.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2026 · Hao X, Du H, Lin B, et al.PMID 42203156DOI 10.1016/j.ejpb.2026.115123
- Preclinical assessment of (177)Lu-DOTA-Pip-Nle-CycMSH(hex): In vivo evaluation and human dosimetry estimation.Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine · 2026 · Zolghadri S, Karimian A, Yousefnia H, et al.PMID 42097084DOI 10.1016/j.apradiso.2026.112660
- Pretargeted (177)Lu/(225)Ac combination therapy of colorectal cancer.Theranostics · 2026 · Rinne SS, Salehi N, Vaughn BA, et al.PMID 42094602DOI 10.7150/thno.126399
- Integrated radio-theranostics using a [(89)Zr]Zr-/[(177)Lu]Lu-labeled B7-H3 antibody-drug conjugate for prostate cancer.Theranostics · 2026 · Qiu Y, Gu T, Wang T, et al.PMID 42094601DOI 10.7150/thno.125878
- Outcome and Safety of Radioligand Therapy With [ 161 Tb]Tb-PSMA-617 After Re-Progression in mCRPC Patients Previously Treated With [ 177 Lu]Lu-PSMA-617.Clinical nuclear medicine · 2026 · Rosar F, Burgard C, Hoang SPT, et al.PMID 42080618DOI 10.1097/RLU.0000000000006384
- (177)Lu-PSMA-617 SPECT/CT for Early Prediction of Overall Survival in Participants with Metastatic Castration-Resistant Prostate Cancer.Radiology · 2026 · Ayati N, Papa N, Crumbaker M, et al.PMID 42048586DOI 10.1148/radiol.252672
- LuRa: Efficacy and Safety of Radium-223 Following [(177)Lu]Lu-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer.Clinical genitourinary cancer · 2026 · Zarka J, Juthani R, Sartor O, et al.PMID 41997765DOI 10.1016/j.clgc.2026.102552
Clinical trials
The 10 most recently updated of 164 ClinicalTrials.gov registrations naming Lutetium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine TumorsRecruiting · Phase 2 · Interventional · 70 enrolled · National Cancer Institute (NCI)NCT04665739updated 2026-06-11
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.Active not recruiting · Phase 1 · Interventional · 31 enrolled · Novartis PharmaceuticalsNCT06379217updated 2026-06-10
- A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.Recruiting · Phase 1 · Phase 2 · Interventional · 58 enrolled · Novartis PharmaceuticalsNCT06247995updated 2026-06-10
- A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)Active not recruiting · Phase 2 · Interventional · 138 enrolled · Novartis PharmaceuticalsNCT07047118updated 2026-06-10
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.Recruiting · Phase 3 · Interventional · 450 enrolled · Novartis PharmaceuticalsNCT05939414updated 2026-06-10
- A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) PatientsNot yet recruiting · Observational · 4,023 enrolled · Novartis PharmaceuticalsNCT07635316updated 2026-06-09
- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast CancerRecruiting · Phase 1 · Interventional · 48 enrolled · Novartis PharmaceuticalsNCT05870579updated 2026-06-08
- A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPCCompleted · Phase 2 · Interventional · 62 enrolled · Novartis PharmaceuticalsNCT05670106updated 2026-06-08
- A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate CancerRecruiting · Phase 1 · Interventional · 300 enrolled · Janssen Research & Development, LLCNCT05818683updated 2026-06-05
- A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate CancerRecruiting · Phase 1 · Interventional · 355 enrolled · Janssen Research & Development, LLCNCT06095089updated 2026-06-05
Note. Data for
lutetium is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.