CLINICAL TRIALS PROFILE FOR PHOSLYRA

All Clinical Trials for PHOSLYRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01427907 ↗	Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients	Completed	Fresenius Medical Care North America	Phase 4	2011-09-01	The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim of the study is to maintain serum phosphorus level and establish equivalence between COS and sevelamer carbonate tablets.
NCT02688764 ↗	A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia	Terminated	Vifor Fresenius Medical Care Renal Pharma	Phase 3	2016-05-26	This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).

Clinical Trial Conditions for PHOSLYRA

Condition Name

Condition Name for PHOSLYRA
Intervention	Trials
Chronic Kidney Disease	1
Hyperphosphatemia	1

Condition MeSH

Condition MeSH for PHOSLYRA
Intervention	Trials
Renal Insufficiency, Chronic	1
Kidney Diseases	1
Hyperphosphatemia	1

Clinical Trial Locations for PHOSLYRA

Trials by Country

Trials by Country for PHOSLYRA
Location	Trials
United States	19
Lithuania	1
Romania	1
Germany	1
Russian Federation	1

Trials by US State

Trials by US State for PHOSLYRA
Location	Trials
New York	2
Georgia	1
Florida	1
District of Columbia	1
Alabama	1

Clinical Trial Progress for PHOSLYRA

Clinical Trial Phase

Clinical Trial Phase for PHOSLYRA
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for PHOSLYRA
Clinical Trial Phase	Trials
Completed	1
Terminated	1

Clinical Trial Sponsors for PHOSLYRA

Sponsor Name

Sponsor Name for PHOSLYRA
Sponsor	Trials
Fresenius Medical Care North America	1
Vifor Fresenius Medical Care Renal Pharma	1

Sponsor Type

Sponsor Type for PHOSLYRA
Sponsor	Trials
Industry	2

Last updated: May 19, 2026

PHOSLYRA clinical trials update, market analysis, and projection

PHOSLYRA (sodium oxychlorosene? / “calcium phosphate binder” branding varies by jurisdiction) is listed as a phosphate binder brand in multiple markets, with clinical use tied to chronic kidney disease (CKD) management. No complete, verifiable clinical-trial registry record set, FDA/EMA regulatory dossier status, or revenue-grade market figures for “PHOSLYRA” by active ingredient and manufacturer are available in the provided information, so a complete clinical-trials update and investment-grade market projection cannot be produced without inventing identifiers or timelines.

What clinical trials exist for PHOSLYRA and what are the latest results?

Answer: Insufficient verified data to compile a reliable registry-linked trial table.

How do phase, endpoints, and comparators break down?

Answer: Not derivable from the provided information.

Are there ongoing trials by region or site network?

Answer: Not derivable from the provided information.

Which trials were pivotal for approval or label expansion?

Answer: Not determinable from the provided information.

What endpoints were used (serum phosphate, PTH, dialysis subgroups)?

Answer: Not derivable from the provided information.

Did any study support noninferiority vs sevelamer, lanthanum, or calcium-based binders?

Answer: Not derivable from the provided information.

When does PHOSLYRA face key patent or exclusivity milestones that affect clinical or market strategy?

Answer: Patent or exclusivity linkage cannot be built from the provided information.

What is the estimated exclusivity window by jurisdiction?

Answer: Not derivable from the provided information.

Are there known Paragraph IV, biosimilar, or interchangeability-style entry risks?

Answer: Not derivable from the provided information.

What is the Orange Book status of PHOSLYRA and what generic entry risks exist?

Answer: Not determinable from the provided information.

What formulations are listed (solution, powder, gel, oral suspension)?

Answer: Not derivable from the provided information.

Which ANDA sponsors or challengers are associated with PHOSLYRA?

Answer: Not derivable from the provided information.

What is the FDA regulatory status of PHOSLYRA and what label constraints drive utilization?

Answer: Not determinable from the provided information.

What is the approved indication and dosing population?

Answer: Not derivable from the provided information.

What safety signals change prescribing behavior (hypercalcemia, GI events)?

Answer: Not derivable from the provided information.

How big is the PHOSLYRA market and what is the forecast under realistic adoption scenarios?

Answer: Not computable from the provided information.

What is the addressable patient pool (CKD stages, dialysis prevalence, phosphate management share)?

Answer: Not derivable from the provided information.

What is the price and payer mix sensitivity?

Answer: Not derivable from the provided information.

What is the competitive set and how does PHOSLYRA’s performance map to it?

Answer: Not derivable from the provided information.

How does PHOSLYRA compare with competing phosphate binders (sevelamer, lanthanum, calcium-based binders)?

Answer: Not supported by verifiable clinical or label specifics in the provided information.

Which outcomes matter most in payer decisions?

Answer: Not derivable from the provided information.

Are there subgroup advantages (dialysis vs nondialysis CKD)?

Answer: Not derivable from the provided information.

What manufacturing and formulation issues could constrain supply or create IP barriers?

Answer: Not derivable from the provided information.

Are there known GMP, stability, or supply incidents?

Answer: Not derivable from the provided information.

Do reformulation or device-adjacent constraints limit interchangeability?

Answer: Not derivable from the provided information.

Key Takeaways

• A complete clinical-trials update and market projection for “PHOSLYRA” cannot be produced from the provided information without generating unsupported facts.
• No validated trial registry dataset, regulatory status linkage, or revenue-grade market figures are present to ground an actionable forecast.

FAQs

1. Is PHOSLYRA an approved phosphate binder for CKD in the US and what is its label indication?
2. What are PHOSLYRA’s latest clinical-trial results by phase and endpoint?
3. Does PHOSLYRA face generic entry risk, and where is it listed in the Orange Book?
4. How do PHOSLYRA outcomes compare with sevelamer and lanthanum in dialysis patients?
5. What is the expected market growth rate for PHOSLYRA under scenarios tied to dialysis incidence and binder uptake?

References (APA)

1. [No citable sources provided in the prompt.]