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Last Updated: April 4, 2025

CLINICAL TRIALS PROFILE FOR VELTASSA


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All Clinical Trials for veltassa

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02694744 ↗ Patiromer With or Without Food for the Treatment of Hyperkalemia Completed Relypsa, Inc. Phase 4 2016-02-01 The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).
NCT01810939 ↗ A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL) Completed Relypsa, Inc. Phase 3 2013-02-01 The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.
NCT01371747 ↗ Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN) Completed Relypsa, Inc. Phase 2 2011-06-01 This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and safety of patiromer and the long term use of patiromer.
NCT01130597 ↗ Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease Completed Relypsa, Inc. Phase 2 2010-05-01 The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD).
NCT00868439 ↗ Evaluation of Patiromer in Heart Failure Patients Completed Medpace, Inc. Phase 2 2009-04-01 The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.
NCT00868439 ↗ Evaluation of Patiromer in Heart Failure Patients Completed Relypsa, Inc. Phase 2 2009-04-01 The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.
NCT02033317 ↗ An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis Terminated Relypsa, Inc. Phase 2 2008-08-01 This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for veltassa

Condition Name

921100123456789HyperkalemiaHeart FailureHyperkalemia (HK)Hypertension[disabled in preview]
Condition Name for veltassa
Intervention Trials
Hyperkalemia 9
Heart Failure 2
Hyperkalemia (HK) 1
Hypertension 1
[disabled in preview] 0
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Condition MeSH

116640-10123456789101112HyperkalemiaRenal Insufficiency, ChronicKidney DiseasesHeart Failure[disabled in preview]
Condition MeSH for veltassa
Intervention Trials
Hyperkalemia 11
Renal Insufficiency, Chronic 6
Kidney Diseases 6
Heart Failure 4
[disabled in preview] 0
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Clinical Trial Locations for veltassa

Trials by Country

+
Trials by Country for veltassa
Location Trials
United States 83
Brazil 12
Spain 9
Germany 7
Mexico 7
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Trials by US State

+
Trials by US State for veltassa
Location Trials
New York 6
Florida 6
California 6
Texas 6
Illinois 4
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Clinical Trial Progress for veltassa

Clinical Trial Phase

38.5%15.4%46.2%00123456Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for veltassa
Clinical Trial Phase Trials
Phase 4 5
Phase 3 2
Phase 2 6
[disabled in preview] 0
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Clinical Trial Status

53.8%15.4%7.7%23.1%01234567CompletedActive, not recruitingRecruiting[disabled in preview]
Clinical Trial Status for veltassa
Clinical Trial Phase Trials
Completed 7
Active, not recruiting 2
Recruiting 1
[disabled in preview] 3
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Clinical Trial Sponsors for veltassa

Sponsor Name

trials01234567891011Relypsa, Inc.Vifor Pharma, Inc.NYU Langone Health[disabled in preview]
Sponsor Name for veltassa
Sponsor Trials
Relypsa, Inc. 10
Vifor Pharma, Inc. 2
NYU Langone Health 1
[disabled in preview] 4
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Sponsor Type

70.0%30.0%002468101214IndustryOther[disabled in preview]
Sponsor Type for veltassa
Sponsor Trials
Industry 14
Other 6
[disabled in preview] 0
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Veltassa: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Veltassa (patiromer sorbitex calcium) is a non-absorbed, cation exchange polymer designed to treat hyperkalemia, a condition characterized by elevated potassium levels in the blood. This article delves into the clinical trials, market analysis, and future projections for Veltassa, highlighting its efficacy, safety, and market impact.

Clinical Trials Overview

Phase III Trials

The pivotal Phase III trial for Veltassa involved 243 patients with hyperkalemia and chronic kidney disease (CKD). This trial was conducted in two parts: Part A, where patients received Veltassa to reduce serum potassium levels, and Part B, where responders were randomized to continue Veltassa or switch to a placebo. The results showed a clinically significant reduction in serum potassium levels, with 76% of patients achieving the target range within four weeks[3][4].

DIAMOND Trial

The DIAMOND trial, a phase-IIIb study, is the largest interventional study to date for potassium binders. It involved over 1,000 patients and demonstrated that Veltassa enabled long-term potassium control, reduced the risk of recurrent hyperkalemia, and allowed more patients to remain on guideline-recommended renin-angiotensin-aldosterone system inhibitor (RAASi) therapy. The trial met its primary and all five key secondary endpoints, highlighting Veltassa's role in optimizing heart failure medical therapy[1].

Pediatric Studies

The EMERALD study focused on pediatric patients with hyperkalemia and CKD. While the data supported the safety and efficacy of Veltassa in patients aged 12 and older, it was insufficient to determine a safe and effective dosing regimen for patients aged 6 to less than 12 years[2].

Efficacy and Safety

Efficacy

Veltassa has consistently shown its ability to reduce serum potassium levels effectively. In the pivotal trial, Veltassa caused a mean reduction of -1.01 mmol/L in serum potassium from baseline at Week 4. Additionally, the DIAMOND trial demonstrated that Veltassa lowered the risk of hyperkalemia events by 37% and allowed more patients to remain on RAASi therapy[1][3].

Safety

The safety profile of Veltassa is primarily defined by gastrointestinal adverse events, such as constipation, diarrhea, abdominal pain, and flatulence. Hypomagnesemia and hypokalemia are also noted but are generally mild to moderate and manageable. These adverse events tend to occur within the first 30 to 60 days of treatment[3][4].

Market Analysis

Market Acquisition and Partnerships

Veltassa was initially developed by Relypsa, an offshoot of Amgen, which acquired the rights for $8.2 million in 2009. Following FDA approval in 2015, Relypsa partnered with Vifor Fresenius Medical Care Renal Pharma, owned by Galenica, to commercialize the drug outside the U.S. In 2016, Galenica fully acquired Relypsa for $1.5 billion and renamed the company CSL Vifor[5].

Market Impact

The acquisition and subsequent commercialization efforts have significantly boosted Veltassa's market presence. The drug addresses a critical need in managing hyperkalemia, particularly in patients with CKD and heart failure, allowing for the continued use of life-saving RAASi therapies. This niche but critical market position has contributed to Veltassa's commercial success.

Market Projections

Growing Demand

The demand for Veltassa is expected to grow due to the increasing prevalence of CKD and heart failure, conditions that often lead to hyperkalemia. The DIAMOND trial's positive outcomes and the ongoing real-world data generation programs, such as the PLATINUM study and the CARE-HK in HF global registry, are likely to further solidify Veltassa's position in the market[1].

Competitive Landscape

While Veltassa is currently the only potassium binder studied in placebo-controlled trials that does not compromise RAASi therapy, the market may see the introduction of new competitors. However, Veltassa's established efficacy and safety profile, along with its extensive clinical trial data, position it strongly against potential competitors.

Future Studies and Expansion

Ongoing and future studies, such as the phase-IV PLATINUM study, will continue to generate evidence-based data on Veltassa's use in various patient populations. These studies are expected to expand the drug's indications and reinforce its market dominance in the treatment of hyperkalemia.

Key Takeaways

  • Efficacy: Veltassa has demonstrated significant reductions in serum potassium levels and reduced the risk of hyperkalemia events.
  • Safety: The drug is well-tolerated, with manageable gastrointestinal and other adverse events.
  • Market Position: Veltassa is a leading treatment for hyperkalemia, particularly in patients with CKD and heart failure, enabling the continued use of RAASi therapies.
  • Market Projections: Growing demand driven by increasing prevalence of CKD and heart failure, along with ongoing real-world data generation programs, is expected to boost Veltassa's market presence.

FAQs

What is Veltassa used for?

Veltassa is used to treat hyperkalemia, a condition characterized by elevated potassium levels in the blood, particularly in patients with chronic kidney disease (CKD) and heart failure.

How does Veltassa work?

Veltassa is a non-absorbed, cation exchange polymer that binds to potassium in the gastrointestinal tract, reducing serum potassium levels.

What were the key findings of the DIAMOND trial?

The DIAMOND trial showed that Veltassa enabled long-term potassium control, reduced the risk of recurrent hyperkalemia, and allowed more patients to remain on guideline-recommended RAASi therapy.

What are the common side effects of Veltassa?

Common side effects include gastrointestinal adverse events such as constipation, diarrhea, abdominal pain, and flatulence, as well as hypomagnesemia and hypokalemia.

Is Veltassa effective in pediatric patients?

Veltassa is effective and safe in pediatric patients aged 12 and older with hyperkalemia and CKD, but there is insufficient data to determine its safety and efficacy in patients aged 6 to less than 12 years.

Who acquired the rights to Veltassa and why is it significant?

Galenica acquired the rights to Veltassa through its acquisition of Relypsa for $1.5 billion in 2016, significantly boosting the drug's commercialization and market presence.

Sources

  1. Vifor Pharma - DIAMOND trial: Veltassa® enables patients to achieve long-term potassium control and optimized RAASi therapy[1].
  2. FDA - Application 205739 S-038|Veltassa[2].
  3. Health Canada - Summary Basis of Decision for Veltassa[3].
  4. FDA - Drug Trials Snapshot: VELTASSA[4].
  5. BioSpace - Pharma's Biggest Losses: Once-Dropped Drugs Make Lucrative Comebacks[5].

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