Overview
Gallium (Ga) 68 prostate-specific membrane antigen (PSMA)-11, or Ga-68 gozetotide, is a radiopharmaceutical agent used to identify and assess prostate-specific membrane antigen (PSMA)-positive lesions in adult men with prostate cancer during positron emission tomography (PET). Prostate cancer is one of the most commonly diagnosed cancers among men in Western countries and many patients treated with androgen-deprivation therapy relapse with castration-resistant prostate cancer. In nearly all prostate cancers, malignant cells express a transmembrane protein called prostate-specific membrane antigen (PSMA). Ga-68 PSMA-11 is an imaging agent that binds PSMA during positron emission tomography: it emits positrons to indicate the presence of PSMA-positive prostate cancer lesions in patients with suspected prostate cancer or in patients who may have recurrent prostate cancer. On December 1, 2020, Ga-68 PSMA-11 was approved by the FDA as the first molecular-targeted drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It is administered intravenously. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended Ga-68 gozetotide be granted marketing authorization for the diagnosis of prostate cancer. In December of the same year, the drug was fully authorized by the EMA. In Octer 2022, Ga-68 PSMA-11 was approved by Health Canada for diagnostic use in men with prostate cancer.
Indication
Gallium Ga-68 gozetotide, or Gallium Ga-68 PSMA-11, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer metastasis with:
Associated Conditions
- Prostate-specific Membrane Antigen Positive Tumors
Research Report
A Comprehensive Monograph on Gallium Ga-68 Gozetotide (Ga 68 PSMA-11): From Molecular Design to Clinical and Regulatory Integration
Drug Profile and Chemical Characteristics
Gallium Ga-68 gozetotide represents a landmark achievement in the field of nuclear medicine and oncology, providing a highly sensitive tool for the detection and staging of prostate cancer. Its design and function are predicated on the precise integration of a targeting molecule, a stable chelator, and a positron-emitting radionuclide. This section establishes the fundamental identity of the agent, detailing its nomenclature, complex molecular structure, and the critical radiochemical properties that enable its function in positron emission tomography (PET).
Nomenclature and Identification
To navigate the scientific literature and clinical documentation, a clear understanding of the agent's various names is essential. The molecule is known by several identifiers across different regulatory and scientific contexts. Its United States Adopted Name (USAN) is Gallium Ga 68 gozetotide, while its International Nonproprietary Name (INN) is Gallium (68Ga) gozetotide.[1] In clinical and research settings, it is most commonly referred to as
Gallium (68Ga) PSMA-11, acknowledging its target (Prostate-Specific Membrane Antigen) and its specific developmental designation.[1]
Commercially, the agent is marketed under several distinct brand names, reflecting its parallel development and commercialization by different pharmaceutical entities. These include Illuccix, developed by Telix Pharmaceuticals, and Locametz, developed by Advanced Accelerator Applications, a Novartis company.[1] Telix has also introduced a next-generation formulation named
Gozellix.[6] The proliferation of brand names for the same active molecule underscores its clinical importance and the competitive commercial landscape.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/12 | Not Applicable | Recruiting | |||
2025/07/04 | Not Applicable | Recruiting | Telix Pharmaceuticals (Innovations) Pty Limited | ||
2025/03/18 | Phase 1 | Not yet recruiting | |||
2024/08/19 | Phase 2 | Recruiting | |||
2024/07/26 | Phase 2 | Completed | |||
2024/07/03 | Phase 2 | Recruiting | |||
2024/06/05 | Phase 2 | Recruiting | |||
2024/04/09 | Not Applicable | Suspended | |||
2023/08/22 | Phase 2 | Recruiting | |||
2023/05/08 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
UCSF Radiopharmaceutical Facility | 24275-0525 | INTRAVENOUS | 5 mCi in 1 mL | 11/8/2023 | |
Advanced Accelerator Applications USA, Inc | 69488-017 | INTRAVENOUS | 25 ug in 1 1 | 3/23/2022 | |
UCLA Biomedical Cyclotron | 76394-2642 | INTRAVENOUS | 5 mCi in 1 mL | 12/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 12/9/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Locametz 25 micrograms, kit for radiopharmaceutical preparation of gallium(68Ga) gozetotide solution | SIN16904P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 25μg/vial | 11/30/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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