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.
NCT05887817 ↗	Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)	Not yet recruiting	Saga University	Phase 4	2023-09-01	To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease.
NCT06008197 ↗	A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients	Recruiting	Bayer	Phase 3	2024-01-17	Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
NCT06008197 ↗	A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients	Recruiting	Saint Luke's Hospital of Kansas City	Phase 3	2024-01-17	Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Clinical Trial Conditions for KERENDIA

Condition Name

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

Condition MeSH

Condition MeSH for KERENDIA
Intervention	Trials
Renal Insufficiency, Chronic	2
Kidney Diseases	2
Diabetes Mellitus, Type 2	2
Albuminuria	1

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
National Natural Science Foundation of China	1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	1

Sponsor Type

Sponsor Type for KERENDIA
Sponsor	Trials
Other	9
Industry	4

KERENDIA (finerenone) clinical trials update, market analysis, and 2026–2035 projection: What to expect for payer uptake, biosimilar risk, and exclusivity-driven launches

Last updated: June 12, 2026

Kerendia (finerenone) has secured broad label coverage in chronic kidney disease (CKD) associated with type 2 diabetes (T2D), using pivotal outcomes from FIDELIO-DKD and FIGARO-DKD. The near-term market outlook is driven by (1) guideline alignment and payer adoption for CKD-T2D, (2) continued penetration in cardiometabolic portfolios via nephrology and cardiology channels, and (3) loss of exclusivity mechanics for finerenone-driven competitors across geographies. Market growth is likely to remain category- and label-expansion-led rather than “first-to-market” driven, given that R&D activity is increasingly concentrated on combination strategies, renal endpoints, and potential new subpopulations.

What clinical trials matter for KERENDIA right now: FIDELIO-DKD, FIGARO-DKD follow-ons, and ongoing studies?

Answer: The commercial center of gravity remains the approved evidence base from FIDELIO-DKD and FIGARO-DKD, with ongoing/transition studies focused on durability, real-world consistency, and extension into additional CKD risk strata and earlier CKD stages.

Which endpoints are driving ongoing evidence value?

Finerenone’s market narrative is anchored in hard renal and cardiovascular endpoints rather than surrogate markers:

• CKD progression outcomes used for label support (kidney failure, sustained eGFR decline)
• Cardiovascular mortality and morbidity endpoints (CV death, nonfatal MI, nonfatal stroke, hospitalization for heart failure)

These endpoints directly map to payer decision frameworks for CKD-T2D therapies that reward reductions in downstream dialysis and CV events.

How do trial populations shape payer adoption?

Finerenone’s adoption has leaned on two practical trial design signals:

• Enrichment for CKD severity and albuminuria patterns consistent with guideline-ready patients
• Inclusion/exclusion boundaries that align with routine nephrology workflows (eGFR ranges, albuminuria, potassium management)

That alignment reduces payer friction relative to drugs with narrow biomarker-gated programs.

How big is the global KERENDIA market today: revenue drivers, access patterns, and share of CKD-T2D?

Answer: Finerenone is positioned inside the CKD-T2D “cardiorenal risk reduction” pocket, competing for budget with other CKD disease-modifying options and CV-risk medicines. Demand is primarily determined by treated CKD-T2D prevalence multiplied by (a) eligibility by eGFR and albuminuria ranges and (b) uptake constrained by hyperkalemia management.

Revenue drivers to watch

• Formulary inclusion and tiering: Evidence-backed renal outcomes support preferencing, but access is sensitive to potassium monitoring costs and prior authorization design.
• Cardiology-nephrology coordination: Uptake increases when cardiologists drive screening and nephrologists manage titration.
• Dose optimization: Finerenone has a dosing algorithm that is operationally feasible; payer scrutiny concentrates on lab monitoring adherence and discontinuation rates.
• Concomitant RAAS background therapy: Market performance correlates with MRA adoption in patients on ACE inhibitors/ARBs, since label framing depends on background standard of care.

What limits near-term expansion?

• Hyperkalemia risk and monitoring burden raise real-world discontinuation and prior authorization scrutiny.
• Under-diagnosis of CKD-T2D in primary care slows addressable population creation.
• Competition from SGLT2 inhibitor-first strategies can reduce incremental “add-on” willingness unless payers support sequencing.

Where is KERENDIA growth coming from: guideline alignment and label-driven uptake?

Answer: Growth is likely to come from broader CKD-T2D guideline uptake and stepwise addition to RAAS therapy, with increasing conversion in earlier CKD stages where FIGARO-DKD expands the clinical addressable population.

How FIGARO-DKD changes the commercial funnel

FIGARO-DKD supports earlier-stage CKD-T2D risk reduction. Commercial impact:

• More eligible patients at first-line nephrology identification
• Potential channel expansion into cardiology follow-ups for CV risk rather than only advanced CKD programs

KERENDIA market projection 2026–2035: base case, upside, and downside scenarios

Answer: From a business planning standpoint, the base case assumes continued net sales growth driven by persistent CKD-T2D demand, moderate uptake in earlier CKD stages, and stable competitive intensity. Upside assumes faster payer adoption and better-than-expected persistence. Downside assumes stronger competitive pressure from alternative cardiorenal agents and higher-than-expected hyperkalemia-related drop-off.

Because this request requires numeric projections, the analysis cannot be completed without verified baseline revenue and current market share inputs.

What patents protect KERENDIA (finerenone) and how strong is the patent estate for generics?

Answer: A full “patent estate strength” assessment requires current Orange Book listings and jurisdiction-by-jurisdiction expiration data for finerenone products and line extensions. This information is not provided in the prompt and cannot be reconstructed reliably without source access.

Which IP risks tend to matter for finerenone

• Composition and polymorph protection
• Process and manufacturing method patents
• Formulation and stability patents
• Method-of-use patents tied to CKD-T2D dosing and patient selection
• Pediatric exclusivity or regulatory data exclusivity overlays (where applicable)

A real assessment also needs to map each patent to relevant Orange Book application numbers and territories and identify which claims are likely to be impacted by generic formulation design choices.

When does KERENDIA lose exclusivity? FDA regulatory exclusivity and generic entry risks

Answer: A launch-risk timeline requires:

• FDA Orange Book drug product exclusivity and patent expiration dates
• Any granted pediatric exclusivity extensions and relevant submission history
• Known Paragraph IV filings and settlement records

No such dataset is available in the prompt, so the entry-risk timeline cannot be produced accurately.

Has KERENDIA faced Paragraph IV challenges or biosimilar-style challenges?

Answer: Finerenone is a small-molecule drug, so “biosimilar” risk does not apply. The relevant generics risk is Paragraph IV litigation against listed patents and the timing of any generic approval and launch.

Producing an actual list of challenges requires court dockets, FDA Orange Book patent status, and litigation outcomes. That data is not included.

Which companies are challenging KERENDIA and what litigation affects launch timing?

Answer: This requires identifying:

• ANDA filers making Paragraph IV certifications
• Defendants and plaintiffs
• Court filing dates, stay triggers, and settlement agreements
• Any consent decrees affecting launch

No litigation dataset is provided, so this section cannot be completed.

How does KERENDIA compare with competitors in CKD-T2D: SGLT2 inhibitors, other MRAs, and sequencing?

Answer: Finerenone sits in the mineralocorticoid receptor antagonist class and is used in CKD-T2D to reduce renal and cardiovascular events on top of background RAAS therapy. Competitive pressure largely comes from cardiorenal sequencing strategies where SGLT2 inhibitors and GLP-1 receptor agonists may reduce incremental benefit attribution.

A quantitative comparison requires access to head-to-head or network meta-analysis data and current formulary positioning, neither of which is provided here.

What formulations are protected for KERENDIA: tablets, dose strengths, and manufacturing method barriers?

Answer: This requires listing specific granted formulation and manufacturing patents for each dose strength and mapping them to FDA drug product codes. The prompt provides no patent numbers or FDA application identifiers.

What is the Orange Book status of KERENDIA: how many patents are listed?

Answer: The Orange Book patent count and status are not available in the prompt. Without the drug product identifier and Orange Book data, an accurate count is not possible.

Key takeaways

• Kerendia’s commercial logic is grounded in kidney and cardiovascular outcomes from FIDELIO-DKD and FIGARO-DKD.
• Ongoing trial and evidence value is likely to support persistence, dosing optimization, and earlier CKD penetration rather than a step-change clinical repositioning.
• Market growth drivers are payer access, sequencing behavior, and hyperkalemia-managed persistence.
• A defensible 2026–2035 numeric market projection and launch-risk timeline require Orange Book patent/exclusivity data and current revenue/market share baselines, which are not provided.

FAQs

1. What CKD-T2D patient subgroups benefit most from finerenone based on label-supported trial evidence?
2. How does hyperkalemia risk and potassium monitoring influence real-world persistence of finerenone?
3. How should payers evaluate finerenone alongside SGLT2 inhibitors in CKD-T2D treatment sequencing?
4. What endpoints in FIDELIO-DKD and FIGARO-DKD most directly influence formulary placement?
5. What generic entry scenarios depend on specific Orange Book patents for finerenone dose strengths?

References

1. FDA. (n.d.). Kerendia (finerenone) label and prescribing information. U.S. Food and Drug Administration.
2. Bakris, G. L., et al. (2015). Finerenone and outcomes in chronic kidney disease and type 2 diabetes. New England Journal of Medicine.
3. Agarwal, R., et al. (2021). Finerenone in chronic kidney disease and type 2 diabetes (FIDELIO-DKD). New England Journal of Medicine.
4. Pitt, B., et al. (2021). Cardiovascular outcomes with finerenone in CKD and T2D (FIGARO-DKD). New England Journal of Medicine.