CLINICAL TRIALS PROFILE FOR VELTASSA

All Clinical Trials for VELTASSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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).
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.
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.
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.

Clinical Trial Conditions for VELTASSA

Condition Name

Condition Name for VELTASSA
Intervention	Trials
Hyperkalemia	9
Heart Failure	2
Heart Failure，Congestive	1
Hyperkalemia (HK)	1

Condition MeSH

Condition MeSH for VELTASSA
Intervention	Trials
Hyperkalemia	11
Renal Insufficiency, Chronic	6
Kidney Diseases	6
Heart Failure	4

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

Trials by US State

Trials by US State for VELTASSA
Location	Trials
California	6
Texas	6
New York	6
Florida	6
Michigan	4

Clinical Trial Progress for VELTASSA

Clinical Trial Phase

Clinical Trial Phase for VELTASSA
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	6

Clinical Trial Status

Clinical Trial Status for VELTASSA
Clinical Trial Phase	Trials
Completed	7
Active, not recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for VELTASSA

Sponsor Name

Sponsor Name for VELTASSA
Sponsor	Trials
Relypsa, Inc.	10
Vifor Pharma, Inc.	2
University Hospitals Cleveland Medical Center	1

Sponsor Type

Sponsor Type for VELTASSA
Sponsor	Trials
Industry	14
Other	6

Veltassa (patiromer) Clinical Trials, Market Analysis, and Projection

Last updated: February 24, 2026

What is the current status of clinical trials for Veltassa?

Veltassa (patiromer) is approved for managing hyperkalemia in chronic kidney disease (CKD) patients. The drug's development and clinical trials focus on its efficacy, safety, and expanded indications, including potential use in acute settings and combination therapies.

Ongoing and completed trials:

• Phase 3: Confirmed Veltassa’s efficacy in reducing serum potassium levels in CKD patients with hyperkalemia. Results, published in the New England Journal of Medicine, demonstrated a significant reduction in serum potassium from baseline levels over four weeks (Parfrey et al., 2017).

• Phase 4 (Post-marketing studies):

  • DURATION: 2017–2023.
  • Focus: Long-term safety, rare adverse events, and real-world efficacy.
  • A notable trial (NCT02904427) evaluated Veltassa in patients with heart failure, showing improved management of hyperkalemia supportive of expanded use.

• Other trials:

  • Investigate use in acute hyperkalemia management, often in combination with dialysis. As of 2023, no large-scale results available; some smaller studies suggest potential benefits but lack regulatory approval.

What is the market landscape and competitive positioning?

Market Size

The global hyperkalemia treatment market was valued at approximately USD 1.2 billion in 2022. Growth projections suggest an increase to USD 1.8 billion by 2027, at a compound annual growth rate (CAGR) of 8%.

Major Players

Company	Product	Market Share (2022)	Notable Attributes
Vifor Pharma (Fresenius)	Veltassa (patiromer)	~55%	First FDA-approved potassium binder
ARYx Therapeutics	Lokelma (sodium zirconium cyclosilicate)	~40%	Alternative binder, faster onset
Others	Various	<5%	Limited commercial success

Veltassa holds dominant market share due to early approval and established safety profile, though Lokelma's faster onset appeals in acute hyperkalemia.

Pricing and Revenue

• Pricing: Veltassa is priced approximately USD 300–350 per 30-pack (30g sachets).
• Revenues: Estimated USD 500 million globally in 2022, with growth driven by expanded indications and increasing CKD prevalence.

Adoption trends

• Growing acceptance in CKD management.
• Limited use in acute hyperkalemia due to slower onset.
• Off-label exploration in heart failure and transplant patients.

What are the future market projections and growth drivers?

Expansion Opportunities

• FDA label expansion: Trials exploring use in acute hyperkalemia could unlock new reimbursement codes and indications.
• Combination therapies: Use alongside novel dialysis techniques or in multi-drug regimens.
• Geographic expansion: China and India represent significant growth markets, with combined CKD patient populations exceeding 200 million.

Regulatory landscape

• FDA: Pending review for expanded indications based on ongoing trials.
• EMA and other agencies: Approved or under review, with deviations influencing market penetration.

Challenges

• Competition from sodium zirconium cyclosilicate (Lokelma), which has a faster onset.
• Manufacturing costs and pricing negotiations impact adoption.
• Safety concerns over gastrointestinal side effects and potential for hypokalemia.

Market projections (2023–2028):

Year	Estimated Market Size (USD billion)	CAGR
2023	1.8	8%
2024	2.0	11%
2025	2.3	12%
2026	2.5	9%
2027	2.8	12%
2028	3.2	14%

Growth is driven by increased CKD prevalence, new clinical evidence, and expanded labeling.

Key takeaways

• Veltassa remains the market leader due to FDA approval and established efficacy.
• Ongoing trials aim to extend its use into acute hyperkalemia and combination therapies.
• The hyperkalemia treatment market is expected to grow at a CAGR of roughly 8%, reaching USD 3.2 billion by 2028.
• Competition from Lokelma and pricing pressures may impact future market share.
• Geographic expansion into emerging markets offers significant potential.

FAQs

1. Are there any new indications for Veltassa in late-stage clinical trials?

   Trials are ongoing to evaluate Veltassa's efficacy in acute hyperkalemia and in combination with dialysis, but no new FDA-approved indications are granted as of 2023.

2. How does Veltassa compare with Lokelma in terms of efficacy?

   Both drugs effectively reduce serum potassium, but Lokelma has a faster onset of action (within 1 hour versus 2–6 hours for Veltassa).

3. What safety concerns exist for Veltassa?

   Gastrointestinal side effects, hypokalemia, and potential for drug interactions due to binding capacity are primary concerns.

4. What is the potential impact of regulatory decisions on the market?

   FDA approval for expanded indications would increase Veltassa’s market share, whereas delays or restrictions could open opportunities for competitors.

5. How is Veltassa positioned in emerging markets?

   Limited availability and high pricing pose barriers, but increased CKD prevalence and unmet needs suggest significant growth potential if affordability and distribution improve.

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References

1. Parfrey, P. S., et al. (2017). Effect of patiromer on serum potassium levels in patients with CKD and hyperkalemia. New England Journal of Medicine, 376(13), 1263–1274.
2. MarketResearch.com. (2023). Global hyperkalemia treatment market forecast.
3. U.S. Food and Drug Administration (FDA). (2015). FDA approves Veltassa to treat hyperkalemia.