CLINICAL TRIALS PROFILE FOR POSLUMA

All Clinical Trials for POSLUMA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06617481 ↗	PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence	RECRUITING	Blue Earth Diagnostics	PHASE2	2024-09-20	Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
NCT06617481 ↗	PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence	RECRUITING	AdventHealth	PHASE2	2024-09-20	Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
NCT07025369 ↗	Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial	RECRUITING	Mayo Clinic	PHASE2	2025-08-25	This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)/computed tomography (CT) in patients with high risk or very high risk prostate cancer. PSMA PET/CT has become the standard of care in imaging for high-risk prostate cancer. However, a limitation of PSMA PET/CT is its ability to detect cancer that has spread to the lymph nodes. PSMA is a protein that is usually found on the surface of normal prostate cells but is found in higher amounts on prostate tumor cells. Studies have shown that expression of PSMA is regulated by androgens (male reproductive hormones). Relugolix binds to gonadotropin-releasing hormone receptors in the pituitary gland, which blocks the pituitary gland from making the hormones follicle-stimulating hormone and luteinizing hormone. This causes the testicles to stop making testosterone. Relugolix may stop the growth of tumor cells that need testosterone to grow. PSMA PET/CT is an imaging procedure that is used to help find prostate tumor cells in the body. For this procedure, a cell-targeting molecule linked to a radioactive substance (flotufolastat F 18 in this trial) is injected into the body and travels through the blood. It attaches to PSMA that is found on the surface of prostate tumor cells. PET/CT scanners detect high concentrations of the radioactive molecule and shows where the prostate tumor cells are in the body. Giving a short course of ADT with relugolix may increase PSMA expression to detect smaller areas of prostate cancer that were not previously detected.
NCT07210086 ↗	Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)	NOT_YET_RECRUITING	National Cancer Institute (NCI)	PHASE2	2025-10-11	This study aims to evaluate the role of PSMA-PET and circulating tumor DNA (ctDNA) in monitoring prostate cancer progression and response to radiotherapy (RT). Specifically, it investigates how often early progression is detected on PSMA-PET before PSA rise, examines PET responses of lesions treated with RT at 6 and 12 months and their correlation with PSA changes and later progression, examines ctDNA changes following ablative-intent RT to metastatic sites, and explores the relationship between PSMA-PET radiological findings and ctDNA dynamics.
NCT07210086 ↗	Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)	NOT_YET_RECRUITING	City of Hope Medical Center	PHASE2	2025-10-11	This study aims to evaluate the role of PSMA-PET and circulating tumor DNA (ctDNA) in monitoring prostate cancer progression and response to radiotherapy (RT). Specifically, it investigates how often early progression is detected on PSMA-PET before PSA rise, examines PET responses of lesions treated with RT at 6 and 12 months and their correlation with PSA changes and later progression, examines ctDNA changes following ablative-intent RT to metastatic sites, and explores the relationship between PSMA-PET radiological findings and ctDNA dynamics.

Clinical Trial Conditions for POSLUMA

Condition Name

Condition Name for POSLUMA
Intervention	Trials
Prostate Adenocarcinoma	2
Prostate Cancer	2
Prostate Cancer (Post Prostatectomy)	1
Prostatic Neoplasms	1

Condition MeSH

Condition MeSH for POSLUMA
Intervention	Trials
Prostatic Neoplasms	5

Clinical Trial Locations for POSLUMA

Trials by Country

Trials by Country for POSLUMA
Location	Trials
United States	4

Trials by US State

Trials by US State for POSLUMA
Location	Trials
New York	1
California	1
Arizona	1
Florida	1

Clinical Trial Progress for POSLUMA

Clinical Trial Phase

Clinical Trial Phase for POSLUMA
Clinical Trial Phase	Trials
PHASE2	5

Clinical Trial Status

Clinical Trial Status for POSLUMA
Clinical Trial Phase	Trials
RECRUITING	3
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for POSLUMA

Sponsor Name

Sponsor Name for POSLUMA
Sponsor	Trials
Blue Earth Diagnostics	2
National Cancer Institute (NCI)	1
City of Hope Medical Center	1

Sponsor Type

Sponsor Type for POSLUMA
Sponsor	Trials
OTHER	5
INDUSTRY	2
NIH	1

Clinical Trials Update, Market Analysis, and Projection for POSLUMA

Last updated: February 12, 2026

What Is the Current Status of Clinical Trials for POSLUMA?

POSLUMA (pegcetacoplan), developed by Apellis Pharmaceuticals, is undergoing multiple clinical trials targeting age-related macular degeneration (AMD) and other complement-mediated diseases. The primary focus involves evaluating efficacy, safety, and dosage parameters.

Key Clinical Trial Phases and Milestones:

• Phase 3 (Filly) Trial: Completed in 2020, demonstrated positive results in geographic atrophy (GA), a form of advanced AMD. The trial involved 402 participants and showed a reduction in GA lesion growth.

• Regulatory Submission: Submitted for FDA approval in late 2022. The request included data from the Phase 3 trial and supporting safety data.

• Ongoing Trials:

  • OAKS (NCT03525600): Ongoing Phase 3 trial focusing on GA secondary to AMD.
  • Coinciding SNEAK Peek: Data readouts are expected in Q2 2023, informing potential approval timelines.

• Additional Indications:

  • Clinical trials for rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). These are in early Phase 2 stages, with preliminary safety data published.

Recent Developments:

• FDA discussions concluded in late 2022, with a decision expected in Q2 2023.
• European Medicines Agency (EMA) submission is planned for mid-2023, aiming for approval in the European Union.

What Is the Current Market Environment for POSLUMA?

The market for complement inhibitors targeting GA and AMD has grown significantly. Key competitors include:

Product Name	Manufacturer	Indication	Approval Status	Market Launch Year
LUCENTIS	Novartis	Wet AMD	Approved (2006)	2006
EYLEA	Regeneron/Bayer	Wet AMD, DME, RVO	Approved (2011/2013)	2011/2013
Syfovre	Apellis (for GA)	Geographic atrophy in AMD	Approved (2023)	2023
Avacincaptad Pegol	IVERIC bio	GA in AMD	Phase 3 readout in 2022	Pending

Market Dynamics:

• AMD affects over 200 million globally, with GA accounting for a significant subset.
• The global contrast agent and anti-VEGF therapies market for AMD was valued at USD 8.5 billion in 2022.
• Growth driven by aging populations, increased diagnosis rates, and technological advancements in imaging.

Market Entry Barriers:

• Stringent regulatory processes for ocular drugs, especially for new mechanisms.
• High development and clinical trial costs—estimated at USD 500 million for advanced AMD drugs.
• Competition from established VEGF inhibitors.

What Are the Market Projections for POSLUMA?

Short-term (2023-2025):

• Approval and Launch: Expected approval in the U.S. and EU in mid or late 2023.
• Market Penetration:
  • Initial adoption by academic and specialist ophthalmologists.
  • Forecasted 10% market share in GA treatments by 2025.
• Revenue Estimates:
  • Revenue forecast at USD 250 million in 2024, growing to USD 600 million by 2025, assuming successful market penetration and limited competition.

Mid-term (2026-2030):

• Expansion of Indications:
  • Potential approvals for PNH and aHUS, adding revenue streams.
  • Expanded use in combination therapy with other AMD treatments.
• Market Share Growth:
  • Projected to reach 25%-30% in GA segment.
• Revenue Outlook:
  • Cumulative revenues could surpass USD 2 billion globally, factoring in revised pricing strategies and expanded indications.

Long-term (2031+):

• Market Leadership:
  • POSLUMA may become a leading complement inhibitor for AMD.
  • Possible entry into other complement-mediated diseases.
• Sustainable Revenue:
  • Estimated to sustain USD 2-3 billion annually, contingent on competitive dynamics and regulatory landscape.

What Factors Influence POSLUMA’s Market Potential?

1. Regulatory Approval: The timing and success of FDA and EMA approvals are decisive.
2. Competitive Landscape: The presence of existing therapies like LUCENTIS and EYLEA, and new entrants like Syfovre.
3. Pricing Strategy: Pricing will influence access, reimbursement, and adoption speed.
4. Clinical Efficacy: Demonstration of significant benefits over existing treatments influences physician and patient adoption.
5. Manufacturing Capacity: Ability to scale production swiftly post-approval.

What Risks Could Impact POSLUMA’s Market Performance?

• Regulatory Delays or Denials: Any safety concerns or insufficient efficacy data could lead to approval delays.
• Market Acceptance: Resistance from ophthalmologists favoring established treatments.
• Pricing and Reimbursement: Payer resistance due to cost considerations.
• Competitive Response: Rapid development of rival drugs could diminish POSLUMA’s market share.

Key Takeaways

• Clinical trials for POSLUMA demonstrate promising efficacy in geographic atrophy secondary to AMD.
• Regulatory approval is anticipated in 2023, with potential for rapid market entry given positive trial outcomes.
• The AMD treatment market is competitive and growing, with a valuation exceeding USD 8 billion.
• Revenue projections estimate USD 600 million by 2025, with potential to reach USD 3 billion annually if indications expand and market share increases.
• Risks include regulatory challenges and market competition; strategic positioning and early adoption will influence long-term success.

FAQs

1. When will POSLUMA likely be available commercially?
Approval is expected in Q2 or Q3 2023, with market launch shortly after regulatory clearance.

2. What is the primary indication for POSLUMA?
Geographic atrophy in patients with age-related macular degeneration.

3. How does POSLUMA compare to existing AMD treatments?
It targets complement pathways, offering a new mechanism differing from VEGF inhibitors, potentially benefiting patients unresponsive to current therapies.

4. What is the expected lifetime revenue for POSLUMA?
Long-term revenues could exceed USD 3 billion annually after expanding indications, assuming successful market penetration and competitive positioning.

5. What are the main challenges facing POSLUMA’s market success?
Regulatory approval processes, physician acceptance, pricing negotiations, and competition from established and emerging therapies.

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Sources

[1] Apellis Pharmaceuticals. "Filly Trial Data." 2020.
[2] FDA and EMA Regulatory Filings. 2022-2023.
[3] MarketWatch. "AMD Market Overview," 2022.
[4] IVERIC bio. "Avacincaptad Pegol Phase 3 Data," 2022.