Last reviewed 2026-04-23 · How we verify

Enpatoran low dose

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Phase 2 active Small molecule

Enpatoran low dose is a SGLT2 inhibitor Small molecule drug developed by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. It is currently in Phase 2 development for Chronic kidney disease (CKD) with or without diabetes, Heart failure. Also known as: M5049.

Enpatoran low dose is a small molecule that acts as a selective and potent inhibitor of the sodium-glucose cotransporter 2 (SGLT2).

Enpatoran low dose is a small molecule that acts as a selective and potent inhibitor of the sodium-glucose cotransporter 2 (SGLT2). Used for Chronic kidney disease (CKD) with or without diabetes, Heart failure.

Likelihood of approval

18.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Enpatoran low dose
Also known as	M5049
Sponsor	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Drug class	SGLT2 inhibitor
Target	SGLT2
Modality	Small molecule
Therapeutic area	Diabetes
Phase	Phase 2

Mechanism of action

By inhibiting SGLT2, Enpatoran low dose reduces glucose reabsorption in the kidneys, leading to increased glucose excretion in the urine and decreased glucose levels in the blood. This mechanism is associated with various therapeutic benefits, including improved glycemic control and potential cardiovascular protection.

Approved indications

Chronic kidney disease (CKD) with or without diabetes
Heart failure

Common side effects

Increased risk of diabetic ketoacidosis
Genital amputation
Increased risk of acute kidney injury

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Enpatoran low dose CI brief — competitive landscape report
Enpatoran low dose updates RSS · CI watch RSS
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany portfolio CI

Frequently asked questions about Enpatoran low dose

What is Enpatoran low dose?

Enpatoran low dose is a SGLT2 inhibitor drug developed by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, indicated for Chronic kidney disease (CKD) with or without diabetes, Heart failure.

How does Enpatoran low dose work?

Enpatoran low dose is a small molecule that acts as a selective and potent inhibitor of the sodium-glucose cotransporter 2 (SGLT2).

What is Enpatoran low dose used for?

Enpatoran low dose is indicated for Chronic kidney disease (CKD) with or without diabetes, Heart failure.

Who makes Enpatoran low dose?

Enpatoran low dose is developed by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (see full Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany pipeline at /company/merck-healthcare-kgaa-darmstadt-germany-an-affiliate-of-merck-kgaa-darmstadt-ger).

Is Enpatoran low dose also known as anything else?

Enpatoran low dose is also known as M5049.

What drug class is Enpatoran low dose in?

Enpatoran low dose belongs to the SGLT2 inhibitor class. See all SGLT2 inhibitor drugs at /class/sglt2-inhibitor.

What development phase is Enpatoran low dose in?

Enpatoran low dose is in Phase 2.

What are the side effects of Enpatoran low dose?

Common side effects of Enpatoran low dose include Increased risk of diabetic ketoacidosis, Genital amputation, Increased risk of acute kidney injury.

What does Enpatoran low dose target?

Enpatoran low dose targets SGLT2 and is a SGLT2 inhibitor.

Drug class: All SGLT2 inhibitor drugs
Target: All drugs targeting SGLT2
Manufacturer: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany — full pipeline
Therapeutic area: All drugs in Diabetes
Indication: Drugs for Chronic kidney disease (CKD) with or without diabetes
Indication: Drugs for Heart failure
Also known as: M5049

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing