Finerenone

{{Short description|Chemical compound}} {{Use dmy dates|date=January 2023}} {{cs1 config |name-list-style=vanc |display-authors=6}} {{Infobox drug | image = Finerenone.svg | image_class = skin-invert-image | alt = | caption =

| pronounce = | tradename = Kerendia | Drugs.com = {{drugs.com|monograph|finerenone}} | MedlinePlus = a621038 | DailyMedID = Finerenone | pregnancy_AU = D | pregnancy_AU_comment = <ref>{{cite web | title=Updates to the Prescribing Medicines in Pregnancy database | website=Therapeutic Goods Administration (TGA) | date=12 May 2022 | url=https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database | access-date=13 May 2022}}</ref><ref name="Kerendia APMDS" /> | pregnancy_category= | routes_of_administration = Oral | class = Potassium-sparing diuretic | ATC_prefix = C03 | ATC_suffix = DA05 | ATC_supplemental =

| legal_AU = S4 | legal_AU_comment = <ref name="Kerendia APMDS">{{cite web | title=Kerendia APMDS | website=Therapeutic Goods Administration (TGA) | date=9 December 2021 | url=https://www.tga.gov.au/resources/auspmd/kerendia | access-date=12 June 2022}}</ref><ref>{{cite web | title=AusPAR: Finerenone | website=Therapeutic Goods Administration (TGA) | date=31 May 2022 | url=https://www.tga.gov.au/auspar/auspar-finerenone | access-date=12 June 2022 }}{{Dead link|date=January 2023 |bot=InternetArchiveBot |fix-attempted=yes }}</ref> | legal_BR =  | legal_BR_comment = | legal_CA = Rx-only | legal_CA_comment = <ref>{{cite web | title=Kerendia Product information | website=Health Canada | date=25 April 2012 | url=https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=102100 | access-date=2 January 2023}}</ref><ref>{{cite web | title=Kerendia Summary Basis of Decision | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?lang=en&linkID=SBD00626&lang=en | access-date=10 March 2023 }}{{Dead link|date=April 2024 |bot=InternetArchiveBot |fix-attempted=yes }}</ref><ref>{{cite web | title=Details for: Kerendia | website=Health Canada | date=22 November 2022 | url=https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102100 | access-date=3 March 2024}}</ref> | legal_DE =  | legal_DE_comment = | legal_NZ =  | legal_NZ_comment = | legal_UK =  | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Kerendia FDA label">{{cite web | title=Kerendia- finerenone tablet, film coated | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fc726765-5d5a-4d6e-b037-b847bda9fb7c | access-date=20 August 2021}}</ref><ref name="FDA Kerendia" /> | legal_EU = Rx-only | legal_EU_comment = <ref name="Kerendia EPAR">{{cite web | title=Kerendia EPAR | website=European Medicines Agency (EMA) | date=14 December 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kerendia | access-date=11 March 2022}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> | legal_UN =  | legal_UN_comment = | legal_status =

| IUPAC_name = (4''S'')-4-(4-Cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide | C=21 | H=22 | N=4 | O=3 | SMILES = NC(=O)C1=C(C)Nc2c(C)cnc(OCC)c2[C@@H]1c3ccc(C#N)cc3OC | StdInChI = 1S/C21H22N4O3/c1-5-28-21-18-17(14-7-6-13(9-22)8-15(14)27-4)16(20(23)26)12(3)25-19(18)11(2)10-24-21/h6-8,10,17,25H,5H2,1-4H3,(H2,23,26)/t17-/m1/s1 | StdInChI_comment = | StdInChIKey = BTBHLEZXCOBLCY-QGZVFWFLSA-N | density = | density_notes = | melting_point = | melting_high = | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation = }}

'''Finerenone''', marketed under the brand name '''Kerendia''' among others, is a medication used to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal myocardial infarctions, and hospitalization for heart failure in adults with chronic kidney disease associated with type{{nbsp}}2 diabetes.<ref name="FDA Kerendia">{{cite web | title=FDA Approves Drug for Chronic Kidney Disease | website=U.S. Food and Drug Administration (FDA) | date=9 July 2021 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease | archive-url=https://web.archive.org/web/20210709173129/https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease | url-status=dead | archive-date=9 July 2021 | access-date=9 July 2021}} {{PD-notice}}</ref> In the United States, it is also approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure and a left ventricular ejection fraction (LVEF) of 40% or greater.<ref>{{Cite web |title=U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority Review |url=https://www.bayer.com/en/us/news-stories/fda-approves-kerendia |archive-url=http://web.archive.org/web/20251031221304/https://www.bayer.com/en/us/news-stories/fda-approves-kerendia |archive-date=2025-10-31 |access-date=2026-02-11 |website=www.bayer.com |language=en}}</ref> Finerenone is a non-steroidal mineralocorticoid receptor antagonist.<ref name="Kerendia FDA label" /> It is taken orally (swallowed by mouth).

Common side effects include abnormally high levels of potassium in the bloodstream, abnormally low levels of sodium in the bloodstream, and abnormally low blood pressure.<ref name="FDA Kerendia" />

Finerenone was approved for medical use in the United States in July 2021,<ref name="FDA Kerendia" /><ref>{{cite press release | title=Bayer's Kerendia (finerenone) Receives U.S. FDA Approval for Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes | publisher=Bayer | via=Business Wire | date=9 July 2021 | url=https://www.businesswire.com/news/home/20210709005441/en/ | access-date=9 July 2021}}</ref> and in the European Union in February 2022.<ref name="Kerendia EPAR" /> The US Food and Drug Administration considers it to be a first-in-class medication.<ref name="New Drug Therapy Approvals 2021">{{cite report | title=Advancing Health Through Innovation: New Drug Therapy Approvals 2021 | website=U.S. Food and Drug Administration (FDA) | date=13 May 2022 | url=https://www.fda.gov/media/155227/download | format=PDF | access-date=22 January 2023 | archive-date=6 December 2022 | archive-url=https://web.archive.org/web/20221206210020/https://www.fda.gov/media/155227/download | url-status=dead }} {{PD-notice}}</ref>

== Medical uses == In the United States, finerenone is indicated to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type{{nbsp}}2 diabetes.<ref name="FDA Kerendia" />

In the European Union, finerenone is indicated for the treatment of chronic kidney disease associated with type{{nbsp}}2 diabetes in adults.<ref name="Kerendia EPAR" /><ref>{{Cite web |date=2021-12-14 |title=Kerendia {{!}} European Medicines Agency (EMA) |url=https://www.ema.europa.eu/en/medicines/human/EPAR/kerendia |access-date=2026-02-11 |website=www.ema.europa.eu |language=en}}</ref>

==Pharmacology== Finerenone has less relative affinity to other steroid hormone receptors than currently available aldosterone antagonists such as eplerenone and spironolactone, which should result in fewer adverse effects like gynaecomastia, impotence, and low libido.<ref name="Ruilope_2017">{{cite journal | vauthors = Ruilope LM, Tamargo J | title = Renin-angiotensin system blockade: Finerenone | journal = Nephrologie & Therapeutique | volume = 13 | pages = S47–S53 | date = April 2017 | issue = Suppl 1 | pmid = 28577743 | doi = 10.1016/j.nephro.2017.02.003 }}</ref><ref>{{cite journal | vauthors = Pitt B, Anker SD, Böhm M, Gheorghiade M, Køber L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Nowack C, Kim SY, Pieper A, Kimmeskamp-Kirschbaum N, Filippatos G | display-authors = 6 | title = Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease | journal = European Journal of Heart Failure | volume = 17 | issue = 2 | pages = 224–32 | date = February 2015 | pmid = 25678098 | doi = 10.1002/ejhf.218 | s2cid = 205781715 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/110733/1/ejhf218.pdf | hdl = 2027.42/110733 | hdl-access = free }}</ref>

This table compares inhibitory (blocking) concentrations (IC<sub>50</sub>, unit: nM) of three antimineralocorticoids. Mineralocorticoid receptor inhibition is responsible for the desired action of the drugs, whereas inhibition of the other receptors potentially leads to side effects. Lower values mean stronger inhibition.<ref>{{cite journal | vauthors = Bärfacker L, Kuhl A, Hillisch A, Grosser R, Figueroa-Pérez S, Heckroth H, Nitsche A, Ergüden JK, Gielen-Haertwig H, Schlemmer KH, Mittendorf J, Paulsen H, Platzek J, Kolkhof P | display-authors = 6 | title = Discovery of BAY 94-8862: a nonsteroidal antagonist of the mineralocorticoid receptor for the treatment of cardiorenal diseases | journal = ChemMedChem | volume = 7 | issue = 8 | pages = 1385–1403 | date = August 2012 | pmid = 22791416 | doi = 10.1002/cmdc.201200081 | s2cid = 36084480 }}</ref>

{| class="wikitable" |- ! ! Spironolactone ! Eplerenone ! Finerenone |- | Mineralocorticoid receptor | 24 | 990 | 18 |- | Glucocorticoid receptor | 2400 | 22,000 | >10,000 |- | Androgen receptor | 77 | 21,200 | >10,000 |- | Progesterone receptor | 740 | 31,200 | >10,000 |}

Finerenone acts as an antagonist to mineralocorticoid receptors harboring the S810L mutation, unlike other traditional inhibitors of mineralocorticoids such as spironolactone and eplerenone that incidentally act as agonists.<ref>{{cite journal | vauthors = Amazit L, Le Billan F, Kolkhof P, Lamribet K, Viengchareun S, Fay MR, Khan JA, Hillisch A, Lombès M, Rafestin-Oblin ME, Fagart J | display-authors = 6 | title = Finerenone Impedes Aldosterone-dependent Nuclear Import of the Mineralocorticoid Receptor and Prevents Genomic Recruitment of Steroid Receptor Coactivator-1 | journal = The Journal of Biological Chemistry | volume = 290 | issue = 36 | pages = 21876–89 | date = September 2015 | pmid = 26203193 | pmc = 4571943 | doi = 10.1074/jbc.M115.657957 | doi-access = free }}</ref>

A meta-analysis of data from seven randomized controlled trials (13,783 participants) found a benefit to using finerenone in people with diabetic kidney disease and overt proteinuria.<ref>{{cite journal | vauthors = Dutta D, Surana V, Bhattacharya S, Aggarwal S, Sharma M | title = Efficacy and Safety of Novel Non-steroidal Mineralocorticoid Receptor Antagonist Finerenone in the Management of Diabetic Kidney Disease: A Meta-analysis. | journal = Indian J Endocrinol Metab | volume = 26 | issue = 3 | date = May–Jun 2022 | pages = 198–205 | pmid = 36248038 | doi = 10.4103/ijem.ijem_376_21 | pmc = 9555385 | doi-access = free }}</ref>

== Adverse effects == Finerenone may cause electrolyte imbalances.<ref name="Drugs.com MTM" /> Symptoms that correlate with higher levels of potassium include nausea, weakness, chest pain, and loss of movement.<ref name="Drugs.com MTM">{{Cite web |title=Finerenone Uses, Side Effects & Warnings |url=https://www.drugs.com/mtm/finerenone.html |access-date=11 June 2022 |website=Drugs.com }}</ref> People with lower levels of sodium may experience headaches, confusion, weakness, and feeling off balance.<ref name="Drugs.com MTM" />

== History == The efficacy of finerenone to improve kidney and heart outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease associated with type{{nbsp}}2 diabetes.<ref name="FDA Kerendia" /> In this study, 5,674 participants were randomly assigned to receive either finerenone or a placebo.<ref name="FDA Kerendia" />

The study compared the two groups for the number of participants whose disease progressed to a composite (or combined) endpoint that included at least a 40% reduction in kidney function, progression to kidney failure, or kidney death.<ref name="FDA Kerendia" /> Results showed that 504 of the 2,833 participants who received finerenone had at least one of the events in the composite endpoint compared to 600 of the 2,841 participants who received a placebo.<ref name="FDA Kerendia" />

The US Food and Drug Administration (FDA) granted the application for finerenone priority review and fast track designations.<ref name="FDA Kerendia" /> The FDA granted the approval of Kerendia to Bayer Healthcare.<ref name="FDA Kerendia" />

== Legal status == In December 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kerendia, intended for the treatment of chronic kidney disease associated with type{{nbsp}}2 diabetes in adults.<ref name="Kerendia: Pending EC decision">{{cite web | title=Kerendia: Pending EC decision | website=European Medicines Agency (EMA) | date=16 December 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/kerendia | access-date=18 December 2021 | archive-date=28 October 2022 | archive-url=https://web.archive.org/web/20221028161708/https://www.ema.europa.eu/en/medicines/human/EPAR/kerendia | url-status=dead }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Finerenone was approved for medical use in the European Union in February 2022.<ref name="Kerendia EPAR" /><ref>{{cite web | title=Kerendia Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1616.htm | access-date=3 March 2023}}</ref>

== Brand names == Finerenone is sold under the brand names Kerendia and Firialta.<ref>{{cite press release | title=Finerenone meets primary endpoint in Phase III FINEARTS-HF cardiovascular outcomes study in patients with heart failure with mildly reduced or preserved ejection fraction | website=Bayer | date=5 August 2024 | url=https://www.bayer.com/media/en-us/finerenone-meets-primary-endpoint-in-phase-iii-finearts-hf-cardiovascular-outcomes-study-in-patients-with-heart-failure-with-mildly-reduced-or-preserved-ejection-fraction/ | access-date=15 October 2024}}</ref>

==Research== {{update section|date=March 2025}} In a phase II study, finerenone reduced urine albumin to creatinine ratio in patients with diabetic kidney disease.<ref>{{cite journal | vauthors = Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM | display-authors = 6 | title = Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial | journal = JAMA | volume = 314 | issue = 9 | pages = 884–94 | date = September 2015 | pmid = 26325557 | doi = 10.1001/jama.2015.10081 | author16 = Mineralocorticoid Receptor Antagonist Tolerability Study–Diabetic Nephropathy (ARTS-DN) Study Group | doi-access = free | hdl = 11370/89b492b9-54de-460c-bfc8-c9b50811dc8b | hdl-access = free }}</ref> Large phase III trials (e.g., FIDELIO-DKD and FIGARO-DKD) have since evaluated finerenone’s effects on renal and cardiovascular outcomes in patients with CKD associated with type 2 diabetes, contributing to regulatory approvals.<ref>{{ClinicalTrialsGov|NCT02540993|Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)}}</ref>{{Full citation needed|date=July 2021}}<ref>{{ClinicalTrialsGov|NCT02545049|Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD)}}</ref>{{Full citation needed|date=July 2021}}

== References == {{Reflist}}

== Further reading == * {{cite journal |vauthors=Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G | display-authors=6 |title=Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes |journal=N Engl J Med |volume=383 |issue=23 |pages=2219–2229 |date=December 2020 |pmid=33264825 |doi=10.1056/NEJMoa2025845 |doi-access=free | title-link=doi |hdl=2445/195806 |hdl-access=free }}

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