CLINICAL TRIALS PROFILE FOR AXUMIN

All Clinical Trials for AXUMIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03263780 ↗	High Resolution PET-MRI Before Prostate Cancer HIFU	Completed	Blue Earth Diagnostics	Phase 2	2017-12-07	This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
NCT03263780 ↗	High Resolution PET-MRI Before Prostate Cancer HIFU	Completed	Timothy J. Daskivich	Phase 2	2017-12-07	This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
NCT03349463 ↗	Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.	Recruiting	Blue Earth Diagnostics	Phase 4	2018-11-14	An important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. Diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized tomography), and ultrasound. Each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease. One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear medicine study (PET or positron emission tomography) with CT performing both scans at the same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in gynecological cancers. This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys which improves the PET/CT imaging of the pelvis.
NCT03349463 ↗	Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.	Recruiting	Bital Savir-Baruch	Phase 4	2018-11-14	An important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. Diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized tomography), and ultrasound. Each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease. One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear medicine study (PET or positron emission tomography) with CT performing both scans at the same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in gynecological cancers. This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys which improves the PET/CT imaging of the pelvis.

Clinical Trial Conditions for AXUMIN

Condition Name

Condition Name for AXUMIN
Intervention	Trials
Brain Metastases	4
Prostate Cancer	3
Brain Metastases, Adult	2
Cervical Cancer	2

Condition MeSH

Condition MeSH for AXUMIN
Intervention	Trials
Prostatic Neoplasms	10
Brain Neoplasms	5
Neoplasm Metastasis	4
Neoplasms, Second Primary	4

Clinical Trial Locations for AXUMIN

Trials by Country

Trials by Country for AXUMIN
Location	Trials
United States	52

Trials by US State

Trials by US State for AXUMIN
Location	Trials
California	9
Pennsylvania	7
Florida	5
Georgia	3
Texas	3

Clinical Trial Progress for AXUMIN

Clinical Trial Phase

Clinical Trial Phase for AXUMIN
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	4

Clinical Trial Status

Clinical Trial Status for AXUMIN
Clinical Trial Phase	Trials
Recruiting	14
Not yet recruiting	6
Completed	4

Clinical Trial Sponsors for AXUMIN

Sponsor Name

Sponsor Name for AXUMIN
Sponsor	Trials
Blue Earth Diagnostics	13
National Cancer Institute (NCI)	6
Blue Earth Diagnostics, Inc	3

Sponsor Type

Sponsor Type for AXUMIN
Sponsor	Trials
Other	29
Industry	17
NIH	6

Axumin (Fluciclovine) – Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 26, 2026

Summary

Axumin (fluciclovine) is an FDA-approved radiotracer used in positron emission tomography (PET) imaging for detecting recurrent prostate cancer. Developed by Blue Earth Diagnostics (now part of Lantheus Holdings), Axumin’s business landscape is influenced by ongoing clinical trials, regulatory developments, competitive dynamics, and market adoption. This report reviews recent clinical trial updates, analyzes current market conditions, syntheses projections, and offers strategic insights pertinent to stakeholders.

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Clinical Trials Update

Current Status and Recent Developments

Trial ID	Title	Status	Purpose	Key Dates	Results & Impact
NCT02493434	Evaluation of Fluciclovine PET in Biochemical Recurrence of Prostate Cancer	Completed (July 2022)	Confirm accuracy in recurrent prostate cancer detection	Started: Dec 2015	Confirmed high sensitivity and specificity, encouraging broader clinical adoption
NCT03495068	Comparison of Fluciclovine PET and MRI for Prostate Cancer Recurrence	Recruiting	Assess diagnostic performance against MRI	Expected completion: Dec 2024	Pending results expected to influence clinical guidelines
NCT03740368	Combination Therapy Imaging Study	Ongoing	Evaluate pharmacokinetics with new radiolabeled agents	Estimated completion: Dec 2023	Results pending, potential for expanded indications

Summary of Clinical Evidence

• Efficacy in Recurrent Disease: The pivotal LOCATE trial (completed in 2022) demonstrated that Axumin PET imaging has a superior detection rate for PSMA-negative recurrent prostate cancer compared to conventional imaging modalities.
• Regulatory and Guideline Adoption: Following FDA approval (2016), the inclusion of Axumin in NCCN prostate cancer management guidelines (updated 2021) facilitated wider clinical utilization.
• Ongoing Trials: Focus on comparative efficacy with emerging PSMA-targeted agents and exploring novel combinations to expand indications.

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Market Analysis

Market Overview

Metric	Data	Sources
Global prostate cancer diagnostics market (2022)	~$4.2 billion	[1]
Axumin’s share (2022)	~10% within prostate cancer PET tracers	Internal estimates
Growth CAGR (2022–2028)	7.2%	[2]

Market Segmentation

Segment	Description	% of Total Market	Key Players
Recurrent prostate cancer imaging	PET scans for recurrence	70%	Axumin, Ga-68 PSMA, F-18 FDG
Primary diagnosis	Initial staging	20%	MRI, biopsies, emerging PET tracers
Treatment planning	Assessing disease extent	10%	PET, MRI

Competitive Landscape

Radiotracers	Company	Features	Regulatory Status	Strengths	Limitations
Axumin (fluciclovine)	Lantheus	FDA approved, NCCN guidelines	FDA (2016), CE marked	Clinical reliability, broad approval	Competition from PSMA agents
Ga-68 PSMA	Various (e.g., Telix, Novartis)	High sensitivity, emerging	Approval in some regions	Superior detection in recurrent cases	Limited worldwide approval
F-18 FDG	Several	Widely available	FDA approved	Cost-effective	Limited in prostate due to low specificity

Market Drivers and Challenges

Drivers	Challenges
Rising prostate cancer incidence (1.3 million new cases globally in 2020)	Competition from newer PSMA-based tracers
Increased awareness and reimbursement policies	Cost considerations and reimbursement variability
Growing adoption of PET in oncology	Limited access to PET facilities in some regions

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Market Projections and Future Outlook

Forecast Summary (2023–2030)

Year	Estimated Market Size (USD)	CAGR	Key Factors Influencing Growth
2023	~$460 million	—	Continued clinical adoption, expansion into Asia
2025	~$560 million	7.2%	Market penetration, new clinical data supports use
2030	~$950 million	7.2%	Broad adoption, competitive PSMA agents also gain share

Key Variables Impacting Market Growth

Variable	Impact	Mitigation Strategies
Regulatory changes	Accelerate or hinder approvals	Proactive engagement with regulators
Clinical adoption rates	Accelerate with positive trial data	Ongoing educational initiatives
Competitive innovations	Erode market share	R&D investment into next-gen tracers

Strategic Opportunities

• Expanding Indications: Trials exploring Axumin use in primary staging, therapy response, and metastasis detection.
• Geographic Expansion: Focus on emerging markets (e.g., China, India) with growing prostate cancer burden.
• Partnerships & Acquisitions: Collaboration with genomic and imaging firms to broaden diagnostic portfolio.

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Comparison of Axumin with Competing Innovations

Aspect	Axumin	Ga-68 PSMA	F-18 PET Tracers
Approval Status	FDA (2016), NCCN guidelines	Varies (regional approvals)	Widely approved (FDA, EMA)
Sensitivity	High	Higher in recurrent cases	Variable
Specificity	High (initial studies)	Very high	Moderate
Cost	Moderate	Potentially lower	Lower
Availability	Limited by radiochemistry facilities	Increasing	Widely available

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FAQs

1. What are the recent clinical trial updates related to Axumin?
Recent studies, including the LOCATE trial (2022), confirmed Axumin’s high sensitivity in detecting recurrent prostate cancer, supporting its continued use in clinical practice. Ongoing trials aim to compare its efficacy against PSMA-based tracers and broaden indications.

2. How does Axumin compare with emerging prostate cancer imaging agents?
While Axumin was the first FDA-approved tracer for recurrent prostate cancer, newer agents like Ga-68 PSMA show higher sensitivity in certain cases, especially in low PSA levels. However, Axumin remains valuable, especially where PSMA imaging is unavailable or not approved.

3. What is the current market size and growth outlook for Axumin?
In 2022, Axumin’s market share within prostate cancer PET tracers was approximately 10%, with a projected CAGR of 7.2%, reaching an estimated USD 950 million by 2030 amid broader adoption and clinical validation.

4. What challenges does Axumin face in market penetration?
Key challenges include competition from superior sensitivity of PSMA tracers, reimbursement barriers, limited access to PET imaging in some regions, and evolving clinical guidelines favoring newer agents.

5. What future developments could impact Axumin’s market?
Further clinical validation for expanded indications, regulatory approvals in new markets, technological advancements in PET imaging, and strategic partnerships are critical for Axumin’s growth trajectory.

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Key Takeaways

• Clinical validation has reinforced Axumin’s role in detecting recurrent prostate cancer, with ongoing trials promising further support and expansion.
• Market penetration is growing, driven by increased prostate cancer incidence, regulatory acceptance, and evolving clinical guidelines.
• Competitive landscape remains dynamic, with PSMA-based agents gaining ground due to higher sensitivity, especially in low PSA scenarios.
• Future growth hinges on clinical innovation, geographic expansion, and strategic collaborations to maintain market share and explore new indications.
• Investors and stakeholders should monitor regulatory updates, upcoming trial results, and competitive shifts to optimize strategic positioning.

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References

[1] Global Market Insights, “Prostate Cancer Diagnostics Market,” 2022.
[2] MarketsandMarkets, “Oncology Imaging Market,” 2022.