Is Finerenone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Finerenone, including Kerendia (10 mg, Film-coated tablet, SAR 381.15); Kerendia (20 mg, Film-coated tablet, SAR 381.15).

Is Finerenone approved by the US FDA?

Drugs@FDA lists 1 application product line for Finerenone, including KERENDIA (Prescription).

Is Finerenone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Finerenone: Kerendia.

Are there safety signals or safety updates for Finerenone?

US FDA: 1 entry (latest 2026-09-16).

Active substance

Finerenone

SFDA 2
US FDA 1
EMA 1
Health Canada 2
US price lines 3
NHS prices 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Kerendia	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 381.15	NCE · Prescription	BAYER AG	Valid
Kerendia	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 381.15	NCE · Prescription	BAYER AG	Valid

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDERS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
KERENDIA	10MG; 20MG; 40MG	tablet · oral	BAYER HLTHCARE	Prescription	9 Jul 2021

EMA European Union — centrally authorised medicines

Kerendia Bayer AG · Authorised · authorised 16 Feb 2022 · ATC C09

Therapeutic indication (EMA)

Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. For study results with respect to renal and cardiovascular events, see section 5.1. Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KERENDIA	02531917	10 MG	TABLET · ORAL	BAYER INC
KERENDIA	02531925	20 MG	TABLET · ORAL	BAYER INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	KERENDIA 10 MG TABLET	$22.85554	per EA	30 Sep 2026
US NADAC	KERENDIA 20 MG TABLET	$22.85154	per EA	30 Sep 2026
US NADAC	KERENDIA 40 MG TABLET	$22.86426	per EA	23 Sep 2026
NHS Drug Tariff	Finerenone 10mg tablets	£36.68	28 tablet	1 Oct 2026
NHS Drug Tariff	Finerenone 20mg tablets	£36.68	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 16 Sep 2026 KERENDIA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations

All safety entries for finerenone →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.