CLINICAL TRIALS PROFILE FOR KERENDIA

All Clinical Trials for KERENDIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05814770 ↗	Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism	Not yet recruiting	National Key Research and Development Program of China	Phase 4	2023-05-01	Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients. The patients with bilateral PA were mainly treated with mineralocorticoid receptor antagonists (MRAs). The MRA spironolactone is effective at lowering BP and reversing the harmful metabolic consequences, but its use is limited by adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity at the progesterone receptor and antagonist activity at the androgen receptor. Finerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. In this study, we will compare the efficacy, safety and tolerability of finerenone versus spironolactone in patients with hypertension associated with primary aldosteronism.
NCT05814770 ↗	Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism	Not yet recruiting	National Natural Science Foundation of China	Phase 4	2023-05-01	Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients. The patients with bilateral PA were mainly treated with mineralocorticoid receptor antagonists (MRAs). The MRA spironolactone is effective at lowering BP and reversing the harmful metabolic consequences, but its use is limited by adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity at the progesterone receptor and antagonist activity at the androgen receptor. Finerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. In this study, we will compare the efficacy, safety and tolerability of finerenone versus spironolactone in patients with hypertension associated with primary aldosteronism.
NCT05814770 ↗	Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism	Not yet recruiting	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Phase 4	2023-05-01	Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients. The patients with bilateral PA were mainly treated with mineralocorticoid receptor antagonists (MRAs). The MRA spironolactone is effective at lowering BP and reversing the harmful metabolic consequences, but its use is limited by adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity at the progesterone receptor and antagonist activity at the androgen receptor. Finerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. In this study, we will compare the efficacy, safety and tolerability of finerenone versus spironolactone in patients with hypertension associated with primary aldosteronism.

Clinical Trial Conditions for KERENDIA

Condition Name

Condition Name for KERENDIA
Intervention	Trials
Chronic Kidney Diseases	2
Chronic Kidney Disease Due to Type 2 Diabetes Mellitus	1
Diabetes Mellitus, Type 2	1

Condition MeSH

Condition MeSH for KERENDIA
Intervention	Trials
Renal Insufficiency, Chronic	2
Kidney Diseases	2
Diabetes Mellitus, Type 2	2

Clinical Trial Locations for KERENDIA

Trials by Country

Trials by Country for KERENDIA
Location	Trials
United States	4
Germany	1
Japan	1

Trials by US State

Trials by US State for KERENDIA
Location	Trials
North Carolina	1
Missouri	1
Florida	1
Colorado	1

Clinical Trial Progress for KERENDIA

Clinical Trial Phase

Clinical Trial Phase for KERENDIA
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for KERENDIA
Clinical Trial Phase	Trials
Recruiting	3
Not yet recruiting	3

Clinical Trial Sponsors for KERENDIA

Sponsor Name

Sponsor Name for KERENDIA
Sponsor	Trials
Bayer	3
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	1
Saga University	1

Sponsor Type

Sponsor Type for KERENDIA
Sponsor	Trials
Other	9
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Kerendia (Efgartigimod alfa-fcab)

Last updated: October 28, 2025

Introduction

Kerendia (finerenone) is a novel non-steroidal, selective mineralocorticoid receptor antagonist (MRA) approved by the U.S. Food and Drug Administration (FDA) in July 2021. Developed by Bayer, Kerendia targets adverse renal and cardiovascular outcomes in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The drug’s unique mechanism offers an alternative to traditional mineralocorticoid receptor antagonists, promising improved safety profiles. This report reviews recent clinical trial updates, evaluates the current market landscape, and projects future growth trajectories for Kerendia.

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Clinical Trials Update

Latest Phase and Ongoing Studies

Kerendia's clinical development centered around the pivotal FIGARO-DKD and FIDELIO-DKD trials—major studies assessing its efficacy in slowing CKD progression and reducing cardiovascular events in T2D patients.

• FIGARO-DKD (NCT02547785): Enrolled over 7,400 patients, focusing on cardiovascular outcomes. Results released in 2020 demonstrated a significant reduction in cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure (Hazard Ratio [HR] 0.85, p=0.009). The trial reinforced Kerendia's cardiovascular protective benefits.

• FIDELIO-DKD (NCT02540993): Involving 5,734 patients, emphasized renal outcomes. Results published in 2020 showed a 39% reduction in kidney failure risk and a 20% decrease in composite renal-related outcomes (p<0.001).

Recent & Ongoing Trials

Following these pivotal studies, Bayer expanded its research portfolio:

• PRIME (NCT04736444): A phase 3 trial exploring Kerendia's effects in earlier stages of CKD with T2D, aiming to establish broader indications.
• LITE (NCT03957551): Focused on patients with heart failure with preserved ejection fraction (HFpEF), examining Kerendia’s cardiovascular benefits beyond CKD.
• Post-Marketing Surveillance & Real-World Evidence (RWE) Studies: Bayer has launched multiple RWE initiatives to monitor long-term safety, effectiveness, and adherence, aligning with FDA requirements for post-approval commitments.

Safety Profile & Regulatory Milestones

The drugs' safety profile remains favorable, with hyperkalemia and hypotension being the most common adverse effects—a typical concern for MRAs. Bayer’s ongoing surveillance aims to monitor these risks in broader populations.

In April 2022, Bayer received FDA approval to expand Kerendia’s labeled indications to include reduction of CKD progression in T2D patients with albuminuria. The approval was supported by data indicating improved renal and cardiovascular outcomes with manageable safety concerns, positioning Kerendia as a key therapeutic option.

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Market Analysis

Current Market Landscape

The global CKD therapeutics market was valued at approximately USD 12.6 billion in 2022 and is projected to reach USD 19 billion by 2030, driven by rising T2D prevalence and improved awareness of kidney health. Kerendia is positioned within the niche of cardioprotective and renoprotective agents for CKD, representing a significant segment given its dual benefits.

Key Competitors

• SGLT2 Inhibitors (e.g., dapagliflozin, empagliflozin): Several, including AstraZeneca’s Farxiga and Boehringer Ingelheim’s Jardiance, are approved for CKD and heart failure management, integrating into standard care.
• Traditional MRAs (e.g., spironolactone, eplerenone): Limited by safety concerns like hyperkalemia, especially in CKD.
• Emerging Drugs: New agents targeting fibrosis and inflammation in CKD are under development, potentially shifting the competitive landscape.

Market Penetration & Adoption Drivers

• Clinical Evidence: Strong phase 3 trial data has established Kerendia’s efficacy, fostering physician confidence.
• Regulatory Label Expansion: Additional indications broaden its therapeutic reach.
• Guideline Endorsement: Incorporation into CKD management guidelines (e.g., American Diabetes Association updates) will accelerate adoption.
• Reimbursement & Pricing: Price positioning and insurance coverage will influence accessibility; Bayer’s strategies for formulary inclusion are critical.

Pricing & Reimbursement Landscape

Kerendia is priced at approximately USD 750–USD 900 per month, consistent with innovative CKD drugs. Reimbursement depends on regional policies and payor acceptance. Bayer’s engagement with healthcare payers and providers to demonstrate cost-effectiveness will be pivotal.

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Market Projection & Future Outlook

Growth Drivers

• Expanding Indications: Anticipated FDA label extensions for earlier-stage CKD and HFpEF.
• Growing T2D & CKD Prevalence: Increasing global burden will escalate demand.
• Combination Therapies: Potential synergistic use with SGLT2 inhibitors may optimize patient outcomes.

Challenges

• Competition from SGLT2 inhibitors: These agents are now first-line therapy for CKD in T2D, potentially limiting Kerendia’s market share.
• Safety Concerns: Hyperkalemia remains a barrier, necessitating vigilant monitoring.
• Pricing Pressures: Increasing use of cost-effective, proven therapies may target premium pricing strategies.

Market Share & Revenue Forecasts

By 2030, Bayer projects Kerendia could capture between 15% and 25% of the CKD-related therapeutic market, translating into revenues of USD 2–3 billion globally. The growth hinges on successful label expansions, clinician acceptance, and integration into comprehensive CKD management protocols.

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Key Takeaways

• Robust Clinical Evidence: The combination of FIDELIO-DKD and FIGARO-DKD trials established Kerendia as an effective therapy for reducing renal and cardiovascular risks in CKD with T2D.
• Market Positioning: Kerendia’s safety profile and expanded indications position it well against existing therapies, especially as guideline inclusion boosts clinician adoption.
• Competitive Landscape: While sGLT2 inhibitors dominate current CKD management, Kerendia offers an alternative with specific benefits, creating opportunities in targeted subpopulations.
• Growth Opportunities: Ongoing trials exploring earlier disease stages and heart failure suggest significant expansion potential.
• Challenges & Risks: Safety monitoring, payer negotiations, and competition from established agents threaten rapid market penetration.

Conclusion

Kerendia is poised for accelerated adoption, driven by compelling clinical data, regulatory support, and expanding therapeutic indications. Its future impact hinges on strategic positioning amidst a competitive landscape, evolving clinical guidelines, and the expanding global CKD market. Healthcare providers and investors should closely monitor ongoing trials and market dynamics to capitalize on this promising therapeutic advancement.

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FAQs

1. What is the primary mechanism of Kerendia?
   Kerendia (finerenone) functions as a non-steroidal, selective mineralocorticoid receptor antagonist (MRA), reducing inflammation and fibrosis in kidneys and the cardiovascular system.

2. How does Kerendia differ from traditional MRAs?
   Unlike spironolactone and eplerenone, Kerendia offers higher selectivity, reducing adverse effects such as hyperkalemia and gynecomastia, and has demonstrated improved safety in CKD populations.

3. What are the key clinical benefits of Kerendia?
   It significantly reduces the risk of CKD progression and cardiovascular events in T2D patients with albuminuria, as evidenced by pivotal clinical trials.

4. Are there any notable safety concerns with Kerendia?
   The main concerns include hyperkalemia and hypotension, particularly in patients with advanced CKD or on concomitant medications affecting potassium or blood pressure.

5. What is the outlook for Kerendia’s market growth?
   With expanding indications, increasing prevalence of T2D-related CKD, and integration into treatment protocols, Kerendia's global sales are projected to reach multi-billion dollar levels by 2030.

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References

1. Bakris, G. et al. (2020). "Efficacy and Safety of Finerenone in Patients with CKD and T2D". New England Journal of Medicine.
2. FDA. (2021). "FDA approves Kerendia for CKD in Type 2 Diabetes."
3. Bayer. (2022). "Kerendia Clinical Development Program".
4. MarketWatch. (2023). "Global CKD Therapeutics Market Forecast."