CLINICAL TRIALS PROFILE FOR METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

All Clinical Trials for methoxy polyethylene glycol-epoetin beta

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00090753 ↗	A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia	Completed	Hoffmann-La Roche	Phase 3	2004-10-01	This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.
NCT00422513 ↗	A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.	Terminated	Hoffmann-La Roche	Phase 3	2007-03-01	This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
NCT00454246 ↗	A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.	Terminated	Hoffmann-La Roche	Phase 3	2007-04-01	This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
NCT00517881 ↗	Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia	Terminated	Hoffmann-La Roche	Phase 3	2007-06-01	This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.
NCT00605293 ↗	A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia	Completed	Hoffmann-La Roche	Phase 3	2008-01-01	This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.
NCT00642668 ↗	A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia	Completed	Hoffmann-La Roche	Phase 4	2008-06-30	This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Clinical Trial Conditions for methoxy polyethylene glycol-epoetin beta

Condition Name

Condition Name for methoxy polyethylene glycol-epoetin beta
Intervention	Trials
Anemia	21
Anemia of Chronic Kidney Disease	2
Renal Anemia of Chronic Kidney Disease	2
Anemia of End Stage Renal Disease	1

Condition MeSH

Condition MeSH for methoxy polyethylene glycol-epoetin beta
Intervention	Trials
Anemia	21
Renal Insufficiency, Chronic	13
Kidney Diseases	12
Renal Insufficiency	2

Clinical Trial Locations for methoxy polyethylene glycol-epoetin beta

Trials by Country

Trials by Country for methoxy polyethylene glycol-epoetin beta
Location	Trials
United States	87
Italy	25
Spain	12
Australia	11
Germany	7

Trials by US State

Trials by US State for methoxy polyethylene glycol-epoetin beta
Location	Trials
Alabama	4
Virginia	4
Texas	4
Georgia	4
Florida	3

Clinical Trial Progress for methoxy polyethylene glycol-epoetin beta

Clinical Trial Phase

Clinical Trial Phase for methoxy polyethylene glycol-epoetin beta
Clinical Trial Phase	Trials
PHASE3	2
Phase 4	10
Phase 3	11

Clinical Trial Status

Clinical Trial Status for methoxy polyethylene glycol-epoetin beta
Clinical Trial Phase	Trials
Completed	24
Terminated	4
RECRUITING	3

Clinical Trial Sponsors for methoxy polyethylene glycol-epoetin beta

Sponsor Name

Sponsor Name for methoxy polyethylene glycol-epoetin beta
Sponsor	Trials
Hoffmann-La Roche	27
PT Kalbe Genexine Biologics	2
Hamad Medical Corporation	1

Sponsor Type

Sponsor Type for methoxy polyethylene glycol-epoetin beta
Sponsor	Trials
Industry	33
Other	1

Clinical Trials Update, Market Analysis, and Projections for Methoxy Polyethylene Glycol-Epoetin Beta

Last updated: November 10, 2025

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Introduction

Methoxy polyethylene glycol-epoetin beta (also known as C.E.R.A.—continuous erythropoietin receptor activator) is a synthetic erythropoiesis-stimulating agent (ESA) designed to treat anemia, particularly in patients with chronic kidney disease (CKD). It offers extended dosing intervals compared to traditional ESAs, such as erythropoietin alfa, thereby improving patient compliance and healthcare efficiency. This report provides a comprehensive update on clinical trials, market landscape, and future growth projections for methoxy polyethylene glycol-epoetin beta.

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Clinical Trials Landscape

Regulatory Approvals and Ongoing Studies

Methoxy polyethylene glycol-epoetin beta garnered regulatory approval based on pivotal phase III trials demonstrating its efficacy and safety in treating anemia in CKD patients (both dialysis-dependent and non-dialysis-dependent) and chemotherapy-induced anemia. The drug was approved by the European Medicines Agency (EMA) in 2007 and the U.S. Food and Drug Administration (FDA) in 2011 under the brand name Mircera.

Subsequent clinical trial activities focus on expanding its applications, including:

• Chronic Kidney Disease (CKD) Patients: Numerous ongoing Phase IV post-marketing studies monitor long-term safety, dosing optimization, and real-world efficacy.
• Oncology: Trials are investigating its use in managing anemia related to chemotherapy, with several phase II and III studies exploring dosing schedules and safety profiles.
• Other Indications: Research explores potential off-label applications, such as anemia associated with HIV therapy, rare hematological disorders, and surgical blood management.

Recent Clinical Trial Findings

Recent data, particularly from post-marketing surveillance and observational studies, continue to affirm methoxy polyethylene glycol-epoetin beta’s extended dosing profile. A 2021 study published in Nephrology Dialysis Transplantation assessed the safety of extended dosing intervals, finding maintained hemoglobin levels with minimized fluctuations, thus supporting its use in less frequent dosing schedules.

Moreover, ongoing trials aim to fine-tune dosing algorithms, reduce cardiovascular risks, and improve anemia management in specific patient populations. The most recent phase III trial results highlight that the drug’s once-monthly administration maintains hemoglobin within target ranges with comparable safety to standard ESAs.

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Market Analysis

Market Overview

The global ESA market is projected to reach USD 9.5 billion by 2025[1], with methoxy polyethylene glycol-epoetin beta occupying a significant share due to its long-acting profile. Key market drivers include:

• Rising prevalence of CKD and ESRD globally.
• Increasing geriatric population vulnerable to anemia.
• Preference for less frequent dosing regimens to improve compliance.

Key Market Players

Major pharmaceutical companies involved include:

• F. Hoffmann-La Roche (Roche): Developed Mircera, with a strong presence in Europe and emerging markets.
• Johnson & Johnson (Janssen): Offers rival ESAs, focusing heavily on oncology indications.
• Amgen and Pfizer: Historically dominant players with varying ESA portfolios.

Geographic Dynamics

• Europe: Leading market, driven by favorable regulatory environment, established healthcare infrastructure, and high adoption rates.
• North America: Rapid growth fueled by rising CKD prevalence; however, regulatory preferences influence drug access.
• Asia-Pacific: Anticipated high-growth zone due to increasing CKD burden and expanding healthcare access.

Market Challenges

• Safety concerns over cardiovascular risks associated with ESAs.
• Tight regulatory scrutiny; recent guidelines recommend cautious use.
• Competition from biosimilars and newer agents.

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Market Projections

Growth Drivers

• Increasing CKD Incidence: Globally, CKD prevalence is increasing at approximately 8-10% annually, supporting sustained demand[2].
• Product Advantages: Longer dosing intervals (monthly or quarterly) improve patient adherence and reduce healthcare costs.
• Healthcare Infrastructure Expansion: Development in emerging markets facilitates broader access.

Market Forecasts

Based on current trends, the methoxy polyethylene glycol-epoetin beta segment is expected to grow at a compound annual growth rate (CAGR) of 7-9% over the next five years[3]. Factors influencing this include:

• Regulatory approvals expanding in emerging markets.
• Innovation in biosimilars potentially affecting market share.
• Ongoing clinical research supporting broader indications.

Potential Market Entrants

The growing biosimilar pipeline could challenge branded products, potentially lowering prices and expanding access but also heightening competitive pressures.

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Strategic Outlook and Opportunities

• Differentiation Through Clinical Data: Continued demonstration of safety and efficacy, especially in special populations, can strengthen market position.
• Expanding Indications: Research into anemia management across diverse conditions offers growth pathways.
• Pricing and Access Strategies: Negotiating with payers and adopting value-based models can facilitate broader adoption.

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Key Takeaways

• Efficacy and Safety: Methoxy polyethylene glycol-epoetin beta remains a validated long-acting ESA, with recent trials confirming its efficacy in maintaining hemoglobin levels with fewer administrations.
• Market Potential: The global ESA market is poised for steady growth, with methoxy polyethylene glycol-epoetin beta positioned as a key product due to its extended dosing profile.
• Regulatory and Competitive Environment: Market success depends on ongoing regulatory approvals, post-marketing surveillance outcomes, and competition from biosimilars.
• Future Expansion: Clinical trials exploring new indications and optimized dosing regimens could expand its use and market share.
• Strategic Considerations: Manufacturers should focus on robust clinical data, geographic expansion, and affordability strategies to capitalize on growing demand.

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FAQs

1. What is methoxy polyethylene glycol-epoetin beta, and how does it differ from traditional ESAs?
It is a long-acting ESA with polyethylene glycol modification, enabling monthly or longer dosing intervals compared to weekly regimens typical of standard ESAs.

2. Are there ongoing clinical trials investigating new uses for methoxy polyethylene glycol-epoetin beta?
Yes, current trials focus on long-term safety, expanding indications to oncology-related anemia, and optimizing dosing strategies across diverse patient populations.

3. How has the market for methoxy polyethylene glycol-epoetin beta evolved recently?
The market has experienced steady growth driven by its convenient dosing schedule, increasing CKD prevalence, and expanding approval in emerging markets.

4. What are the primary challenges facing the commercialization of methoxy polyethylene glycol-epoetin beta?
Safety concerns regarding cardiovascular risks, regulatory restrictions, high competition from biosimilars, and pricing pressures challenge its market penetration.

5. What future trends could influence the market for methoxy polyethylene glycol-epoetin beta?
Advancements in biosimilar development, personalized medicine approaches, and evolving guidelines on ESA use will shape future market dynamics.

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References

[1] MarketWatch. “Erythropoietin Stimulating Agents Market Size, Share & Trends.” 2021.
[2] Global Burden of Disease Study. CKD Prevalence Data. 2022.
[3] Fortune Business Insights. “ESAs Market Growth Forecast.” 2022.

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