Gallium
US-FDASourced from openFDA
GET
/api/v1/drug/galliumApproval history
Sourced from openFDA- Feb 1, 1979NDANDA018058Curium
- Aug 21, 2019NDANDA210828Uihc Pet Imaging
- Dec 1, 2020NDANDA212642Univ Ca Los Angeles
- Dec 1, 2020NDANDA212643Univ Of Ca San Fran
- Dec 17, 2021NDANDA214032Telix
- Mar 23, 2022NDANDA215841Novartis
- May 14, 2026ANDAANDA219189Ionetix
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.
421 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.
- 1Injection Site Pain12830%
- 2Hot Flush337.8%
- 3Erectile Dysfunction255.9%
- 4Fatigue174.0%
- 5Death112.6%
- 6Burning Sensation92.1%
- 7Muscular Weakness92.1%
- 8Overdose92.1%
- 9Pathological Fracture92.1%
- 10Rash92.1%
- 11Asthenia81.9%
- 12Injection Site Discomfort81.9%
- 13Positron Emission Tomogram Abnormal81.9%
- 14Anaemia71.7%
- 15Cerebral Amyloid Angiopathy71.7%
Literature
Recent PubMed references pinned to Gallium as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Gallium Protoporphyrin and Lipid Crystalline Nanoparticles Promote the Activity of Ampicillin against MRSA.ACS infectious diseases · 2026 · Awad M, Feizi S, Wormald PJ, et al.PMID 42207859DOI 10.1021/acsinfecdis.6c00202
- Establishment of (68)Ga-DOTA-Based Pretargeted Radioimmunodiagnosis.Molecular pharmaceutics · 2026 · Veach DR, Burnes Vargas D, Islam B, et al.PMID 42151769DOI 10.1021/acs.molpharmaceut.5c01766
- Preclinical characterization of a novel FAP-targeted PET tracer, [(68)Ga]Ga-CB6NT-FAPI.Nuclear medicine and biology · 2026 · Seo HY, Kim HS, Yoo RJ, et al.PMID 42119447DOI 10.1016/j.nucmedbio.2026.109632
- Specific imaging of bacterial infection: a translational approach using positron emission tomography and gallium-68-labeled maltohexaose.Theranostics · 2026 · Wegener SM, Weiberg D, Thackeray JT, et al.PMID 42094617DOI 10.7150/thno.125904
- Novel Covalent FAP-Targeted [(68)Ga]Ga-DOTA-mFS-KERERG-FAP-2286 for Improved Pharmacokinetics and Enhanced Tumor Uptake.Molecular pharmaceutics · 2026 · Jin Z, Wu T, Tang S, et al.PMID 42052981DOI 10.1021/acs.molpharmaceut.6c00249
- Interaction of bi-nuclear gallium(III) complexes with human serum albumin and impact on potency towards osteosarcoma stem cells.Dalton transactions (Cambridge, England : 2003) · 2026 · Feng X, Suntharalingam KPMID 42023658DOI 10.1039/d6dt00591h
- The Clinical Significance of Gallium-68 PSMA-11 PET-Derived SUVmax in the Management of Metastatic Hormone-Sensitive Prostate Cancer.The Prostate · 2026 · Kıkılı Cİ, Kapar C, Yağmur FH, et al.PMID 42018584DOI 10.1002/pros.70185
- Toward circular Gallium: Recovery pathways from Bayer Liquor, red Mud, fly Ash, and e-waste.Waste management (New York, N.Y.) · 2026 · Zhang X, Zhang Z, Fu J, et al.PMID 42008918DOI 10.1016/j.wasman.2026.115543
Clinical trials
The 10 most recently updated of 332 ClinicalTrials.gov registrations naming Gallium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing SyndromeRecruiting · Phase 2 · Interventional · 80 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NCT02019706updated 2026-06-12
- [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck CancersRecruiting · Phase 1 · Interventional · 120 enrolled · National Cancer Institute (NCI)NCT06479811updated 2026-06-12
- Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine TumorsCompleted · Phase 3 · Interventional · 69 enrolled · Jiangsu HengRui Medicine Co., Ltd.NCT06091748updated 2026-06-12
- Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate CancerRecruiting · Phase 1 · Interventional · 42 enrolled · Weill Medical College of Cornell UniversityNCT04886986updated 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
- 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 Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung CancersRecruiting · Phase 1 · Interventional · 36 enrolled · Novartis PharmaceuticalsNCT07117214updated 2026-06-09
- PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical EvaluationCompleted · Phase 1 · Interventional · 20 enrolled · University Hospital, BordeauxNCT02134639updated 2026-06-09
- An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)Active not recruiting · Phase 3 · Interventional · 1,140 enrolled · Novartis PharmaceuticalsNCT04720157updated 2026-06-08
Frequently asked questions
- What are the brand names for Gallium?
- Gallium is marketed under brand names including Ganite.
Note. Data for
gallium 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.