Ionetix Receives First ANDA Approval for Gallium Ga-68 Gozetotide PSMA-PET Imaging Agent
Key Insights
Ionetix Corporation has become the first commercial drug manufacturer to receive FDA approval for an Abbreviated New Drug Application for Gallium Ga-68 gozetotide, a radioactive diagnostic agent for prostate cancer imaging.
The approved agent enables PSMA-PET scanning in men with prostate cancer who have suspected metastasis or recurrence based on elevated PSA levels.
The approval allows Ionetix to expand access to this diagnostic tool through its multi-site network of PET facilities, particularly targeting underserved areas.
Ionetix Corporation announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Gallium Ga-68 gozetotide, marking the company as the first commercial drug manufacturer to receive ANDA approval for this radioactive diagnostic agent. The approval enables the particle accelerator company to expand its portfolio of positron emission tomography diagnostics for prostate cancer patients.
Clinical Application and Indication
Gallium Ga-68 gozetotide injection is indicated for positron emission tomography (PET) scanning of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. The diagnostic agent is specifically designed for patients with suspected metastasis who are candidates for initial definitive therapy, as well as those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.
"Ionetix is excited to have the opportunity to offer gallium Ga-68 gozetotide to enable PSMA-PET imaging of men with prostate cancer," said Jill Wilson, Vice President of Regulatory Affairs and Quality Assurance at Ionetix. "This approval will allow Ionetix to provide doses to underserved areas from our existing multi-site network of PET facilities."
Product Specifications and Distribution
The approved product is supplied in a single-dose capped syringe containing approximately 8 to 10mL of the radioactive diagnostic agent. Due to its radioactive nature, the product has a three-hour expiration period from the end of synthesis, requiring careful coordination in manufacturing and distribution logistics.
Ionetix's approval comes as the company leverages its patent-protected superconducting cyclotron technology, which supports unique particle accelerator solutions with applications across medical and industrial sectors. The company is currently generating revenue in the medical isotopes space, encompassing both PET diagnostics and alpha emitter therapeutics.
Company Portfolio and Technology Platform
Beyond the newly approved PSMA imaging agent, Ionetix operates as a leader in cyclotron technology and radioisotope manufacturing. The company provides innovative solutions that enable access to scarce isotopes for both diagnostic and therapeutic radiopharmaceuticals. Ionetix supplies high-purity Actinium-225 (Ac-225) and Astatine-211 (At-211) for use in targeted alpha therapies, supported by a comprehensive distribution network, contract drug manufacturing services, and specialized logistics to ensure global access to these critical medical isotopes.