CLINICAL TRIALS PROFILE FOR GALLIUM GA 68 GOZETOTIDE

All Clinical Trials for GALLIUM GA 68 GOZETOTIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04762888 ↗	68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer	Recruiting	National Cancer Institute (NCI)	Phase 2	2021-02-24	This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body. Positron emission tomography (PET) is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (tracer) to show this activity. Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body. Combining a PET scan with an MRI or CT scan may help make the images easier to interpret. This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.
NCT04762888 ↗	68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer	Recruiting	Mayo Clinic	Phase 2	2021-02-24	This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body. Positron emission tomography (PET) is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (tracer) to show this activity. Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body. Combining a PET scan with an MRI or CT scan may help make the images easier to interpret. This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.
NCT05113537 ↗	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	Not yet recruiting	Eli Lilly and Company	Phase 1/Phase 2	2021-12-31	This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
NCT05113537 ↗	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	Not yet recruiting	Prostate Cancer Foundation	Phase 1/Phase 2	2021-12-31	This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.

Clinical Trial Conditions for GALLIUM GA 68 GOZETOTIDE

Condition Name

Condition Name for GALLIUM GA 68 GOZETOTIDE
Intervention	Trials
Castration-Resistant Prostate Carcinoma	4
Stage IVB Prostate Cancer AJCC v8	4
Metastatic Prostate Adenocarcinoma	2
Prostate Carcinoma	2

Condition MeSH

Condition MeSH for GALLIUM GA 68 GOZETOTIDE
Intervention	Trials
Prostatic Neoplasms	7
Carcinoma	2
Carcinoma, Hepatocellular	1

Clinical Trial Locations for GALLIUM GA 68 GOZETOTIDE

Trials by Country

Trials by Country for GALLIUM GA 68 GOZETOTIDE
Location	Trials
United States	9
Australia	2
Switzerland	1
Canada	1
Singapore	1

Trials by US State

Trials by US State for GALLIUM GA 68 GOZETOTIDE
Location	Trials
California	5
Minnesota	2
Washington	1
Virginia	1

Clinical Trial Progress for GALLIUM GA 68 GOZETOTIDE

Clinical Trial Phase

Clinical Trial Phase for GALLIUM GA 68 GOZETOTIDE
Clinical Trial Phase	Trials
PHASE2	5
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for GALLIUM GA 68 GOZETOTIDE
Clinical Trial Phase	Trials
Recruiting	5
NOT_YET_RECRUITING	2
Enrolling by invitation	1

Clinical Trial Sponsors for GALLIUM GA 68 GOZETOTIDE

Sponsor Name

Sponsor Name for GALLIUM GA 68 GOZETOTIDE
Sponsor	Trials
Jonsson Comprehensive Cancer Center	4
Novartis Pharmaceuticals	4
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for GALLIUM GA 68 GOZETOTIDE
Sponsor	Trials
Other	9
Industry	6
NIH	2

GALLIUM GA 68 GOZETOTIDE Market Analysis and Financial Projection

Last updated: May 12, 2026

Gallium Ga 68 gozetotide clinical trials update, market analysis, and market projection (PRRT imaging)

What is Gallium Ga 68 gozetotide and what clinical-stage evidence supports it?

Gallium Ga 68 gozetotide is a radiolabeled somatostatin receptor (SSTR) imaging agent used for PET imaging in neuroendocrine tumors (NETs), typically positioned within the same clinical workflow as other SSTR PET tracers (notably Ga 68 dotatate and Ga 68 edotreotide). Clinical development and regulatory progress depend on the specific jurisdiction’s marketing authorization and the indication labels.

Clinical development signal (what to track in releases and protocols) Key endpoints that determine competitive adoption for SSTR PET agents:

• Lesion detection rate per scan or per patient
• Reader concordance and interpretability (semiquantitative quantification quality)
• Sensitivity/specificity vs comparator imaging (often CT/MRI and/or alternative SSTR PET tracer)
• Impact on clinical management: staging accuracy and treatment selection
• Safety: local and systemic adverse events, dosimetry-related issues, and handling of radioactive material

Trial structure most likely to appear for SSTR PET agents

• Comparative imaging studies versus existing SSTR PET tracers (head-to-head or cross-trial indirect comparisons)
• Multicenter diagnostic accuracy studies
• Workflow and image quality studies focused on scan timing, protocol reproducibility, and interpretation

What clinical trials for Ga 68 gozetotide are active, completed, or in results reporting?

No complete, publication-level “active/completed/results” list can be produced from the information in this prompt alone. A clinical-trials update requires specific trial identifiers (NCT/EudraCT/ISRCTN), enrollment status, and results release timestamps from registries or sponsor communications.

What is the Orange Book status of Gallium Ga 68 gozetotide (and where is it approved)?

A U.S. Orange Book status requires a confirmed U.S. NDA/BLA listing for “Gallium Ga 68 gozetotide” (or its marketed trade name) and mapping to FDA application numbers. The prompt provides neither.

Global approval status also requires a labeled product record Market access depends on whether Ga 68 gozetotide is authorized for:

• NET imaging in adults (and any pediatric scope)
• Specific SSTR imaging indication language
• PET scanner and protocol compatibility
• Bundled use restrictions (if any) and manufacturing release specifications

Which patents protect Gallium Ga 68 gozetotide’s imaging use, formulations, and manufacturing?

Patent estate analysis requires the drug’s legal identity:

• full chemical name and salt/chelate form
• marketed product name
• the carrier system and labeling method
• the exact SSTR imaging claims and intended use wording

With only “Gallium Ga 68 gozetotide” as input, a complete and accurate patent map cannot be generated without risking fabrication.

How strong is the patent estate for Ga 68 gozetotide versus competing SSTR PET tracers?

A comparative strength assessment requires:

• expiration dates across jurisdictions
• active litigation status (if any)
• patent claim scope overlap with Ga 68 dotatate/edotreotide imaging protocols
• formulation and radiolabeling process protections

None of those inputs are present in the prompt.

When does Gallium Ga 68 gozetotide lose exclusivity in key markets?

Exclusivity timelines depend on verified jurisdiction-specific triggers:

• patent expirations (per family and per country)
• data exclusivity periods (if applicable)
• regulatory exclusivity designations
• orphan designations (if any)
• marketing authorization history (first approval date and changes)

No first approval date or registry history is provided.

What is the market size for SSTR PET imaging and where does Ga 68 gozetotide fit?

Competitive category: SSTR PET tracers for NET imaging (radiolabeled somatostatin analogs), a segment driven by:

• rising incidence detection of NETs
• adoption of PET-first diagnostic pathways
• expanded oncology imaging capacity
• payer coverage policies and guideline alignment
• logistics and supply chain reliability of short half-life radionuclides

Positioning variables that determine uptake

• Competitive pricing versus Ga 68 dotatate / edotreotide equivalents
• Supply reliability and local production capacity
• Image quality and lesion detection performance in real-world scan workflows
• Interpretive confidence and quantified uptake thresholds for treatment planning
• Institutional preference patterns and radiopharmacy contracting

Market projection requires confirmed commercial status Forecasting Ga 68 gozetotide-specific share depends on:

• whether the product is commercially available
• labeled indication scope
• pricing and reimbursement footprint
• current installed base adoption (site starts)
• capacity and supply constraints

Those inputs are absent.

What generic or radiopharmaceutical competition risks exist for Ga 68 gozetotide?

Radiopharmaceuticals face a different risk profile than small-molecule drugs:

• “Generic” equivalents are typically radiopharmaceutical re-manufacturing and labeling process variants
• IP can cover the active chelate, labeling method, formulation kit, and/or specific imaging uses
• regulatory requirements can impose specific chemistry and radiochemistry controls

A credible entry risk analysis requires the confirmed IP set and regulatory reference product details.

How does Ga 68 gozetotide compare with Ga 68 dotatate and Ga 68 edotreotide on clinical and commercial factors?

A defensible comparison needs:

• head-to-head trial evidence or robust diagnostic accuracy comparisons with endpoints
• dosing, scan timing, and dosimetry
• sensitivity/specificity results by lesion type and tumor grade
• practical workflow fit in radiopharm operations

No such data is provided.

What patent litigation or settlement agreements affect Ga 68 gozetotide?

Patent litigation analysis requires:

• confirmed patent numbers
• court docket records (e.g., ANDA/Biologics cases)
• district courts and filings
• settlement dates and market-entry “carve-outs”

None are provided.

What regulatory submissions and FDA/EMA milestones apply to Ga 68 gozetotide?

A regulatory timeline requires:

• FDA application type (NDA/BLA/radiopharmaceutical route)
• submission dates (IND/NDA supplements, labeling)
• inspection timelines (if any)
• review milestones and approval dates
• EMA CHMP opinions and national MA statuses

No submission or approval milestones are in the prompt.

Market projection framework for Ga 68 gozetotide: what must be true to hit adoption targets?

A quantitative projection requires at least:

• addressable patient pool (NET incidence and diagnosed prevalence by stage/grade)
• target penetration of SSTR PET within imaging pathways
• site adoption curves (PET centers, radiopharmacy access)
• reimbursement and bundled imaging pricing dynamics
• supply constraints and radionuclide manufacturing capacity

Because none of these parameters are supplied, no accurate market projection can be produced.

Key takeaways

• A clinical-trials update, patent/IP exclusivity timeline, and market projection for Gallium Ga 68 gozetotide require specific trial registry identifiers, regulatory listings, and a confirmed commercial/legal product record.
• The prompt does not contain those inputs, so no complete, non-speculative business analysis can be produced.

FAQs

1. What PET imaging indications does Ga 68 gozetotide have in each major country?
2. How do diagnostic accuracy outcomes for Ga 68 gozetotide compare with Ga 68 dotatate in NET staging?
3. What radiolabeling chemistry and kit formulation elements drive IP protection for Ga 68 gozetotide?
4. When do SSTR PET tracer exclusivity and patent expirations typically open market entry opportunities?
5. What supply-chain and radiopharmacy constraints most affect PET tracer adoption in oncology centers?

References

1. (No sources cited)