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Ga 68 PSMA-11

Generic Name
Ga 68 PSMA-11
Brand Names
Locametz
Drug Type
Small Molecule
Chemical Formula
C44H59GaN6O17
CAS Number
1906894-20-9
Unique Ingredient Identifier
ZJ0EKR6M10

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

Published: Aug 12, 2025

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.

Continue reading the full research report

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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