GALLIUM GA 68 GOZETOTIDE (gallium ga-68 gozetotide) · RADIOMEDIX
Gallium Ga 68 gozetotide is a diagnostic tool used for PET imaging in men with prostate cancer to locate PSMA-positive lesions. It helps patients with suspected metastasis who are candidates for initial therapy, as well as those with rising PSA levels that suggest the cancer may have returned. This agent also helps clinicians identify which individuals are suitable candidates for PSMA-directed treatments.
How GALLIUM GA 68 GOZETOTIDE Works
This agent works by targeting and binding to prostate-specific membrane antigen (PSMA), a protein often overexpressed on the surface of malignant prostate cancer cells. It contains gallium-68, a radioactive isotope that emits signals detectable by PET scans, allowing for the visualization of these cancer cells throughout the body.
Details
- Status
- Prescription
- First Approved
- 2020-12-01
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
GALLIUM GA 68 GOZETOTIDE Approval History
What GALLIUM GA 68 GOZETOTIDE Treats
3 indicationsGALLIUM GA 68 GOZETOTIDE is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
- Metastasis
- Recurrence
GALLIUM GA 68 GOZETOTIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in GALLIUM GA 68 GOZETOTIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GALLIUM GA 68 GOZETOTIDE treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05176223 | 21-007799 NCI-2021-12377 | Ph 2 | completed | 68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer |
| NCT04777071 | RG1007462 NCI-2020-02612, 10512 | Ph 2 | active not recruiting | An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer |
| NCT04762888 | 20-006433 NCI-2021-01092, W81XWH-20 | Ph 2 | completed | 68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer |
| NCT05547386 results posted | 22-003732 NCI-2022-04135 | Ph 3 | completed | 68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer |
| NCT04750473 results posted | STUDY00000675 NCI-2020-00366, WINSHIP4933-19 | Ph 1 | completed | Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer |
| NCT04279561 | 19-002024 NCI-2020-00239 | Ph 1 | terminated | Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GALLIUM GA 68 GOZETOTIDE FDA Label Details
Indications & Usage
FDA Label (PDF)LOCAMETZ, after radiolabeling with gallium-68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products. LOCAMETZ, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for positr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.