JW Pharma begins developing triple therapy combining Livalozet + SGLT-2 inhibitors

Combining the SGLT-2 inhibitor 'empagliflozin' with pitavastatin and ezetimibe

Targeting patients who have chronic disease concurrently presenting with type 2 diabetes and dyslipidemia…enhanced dosing convenience

JW Pharmaceutical has officially begun developing a next-generation fixed-dose combination (FDC) triple therapy, combining an SGLT-2 inhibitor-class antidiabetic agent into its dyslipidemia treatment, 'Livalo.'

The company's strategy aims to solidify its leadership in the chronic multimorbidity market by merging the potent lipid-lowering efficacy of the existing 'Livalozet (pitavastatin + ezetimibe)' with glycemic control.

According to the Ministry of Food and Drug Safety (MFDS), JW Pharmaceutical secured Investigational New Drug (IND) approval on the 2nd for a Phase 1 clinical trial of its investigational FDC triple therapy candidate, 'JW0113.'

This clinical study will enroll 64 healthy adult volunteers and is scheduled to run from December 2026 to December 2027. The trial is designed as an open-label, randomized, 2-sequence, 4-period, fasting, single-dose, oral, replicated crossover study. The objective is to demonstrate bioequivalence by comparing the pharmacokinetic (PK) profiles and safety of the FDC candidate 'JW0113' administered alone versus co-administration with the corresponding reference listed drugs.

Notably, as the primary pharmacokinetic endpoints specify the area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) and peak plasma concentration (Cmax) for pitavastatin, total ezetimibe, and empagliflozin, it was confirmed that this pipeline candidate is an FDC triple therapy combining the active pharmaceutical ingredients of Livalozet with empagliflozin, a flagship SGLT-2 inhibitor.

The chronic disease FDC market pioneered by 'Zemiglo' and 'Rosumet'… now advancing to 'triple combination therapy'

With more than 70% to 80% of domestic diabetic patients concurrently presenting with dyslipidemia, the two conditions represent a quintessential multimorbidity. Due to the clinical nature of these diseases, patients often face a high pill burden, which tends to compromise medication adherence. Consequently, the pharmaceutical industry moved early to introduce combination therapies to manage both conditions simultaneously.

In the domestic market, products such as LG Chem's 'Zemiglo (gemigliptin + rosuvastatin, a DPP-4 inhibitor + statin)' and Yuhan's 'Rosumet (rosuvastatin + metformin, a statin + first-line antidiabetic agent)' opened the era of 'diabetes + dyslipidemia' FDCs and are recognized as benchmark cases that enhanced patient dosing convenience.

However, as recent cardiovascular disease prevention guidelines have adopted more stringent LDL cholesterol targets, the mainstream paradigm in lipid management has shifted from 'statin monotherapy' to 'statin + ezetimibe combination therapy.' Concurrently, combination regimens involving 'SGLT-2 inhibitors,' which have demonstrated cardiovascular and renal protective benefits, have become the standard of care in diabetes management. Accordingly, as market demand moves beyond existing dual therapies (one statin + one antidiabetic agent), there is rapid emerging demand for a generational transition to 'triple FDCs' that fuse the most potent lipid-lowering combination, 'statin + ezetimibe', with next-generation antidiabetic agents.

Evolution of the 'Livalo Family'… Expanding from hypertension and mixed dyslipidemia into 'diabetes'

JW Pharmaceutical has continuously diversified its product portfolio, anchored by its pitavastatin monotherapy, 'Livalo Tab.' The company has established a comprehensive cardio-cerebrovascular and chronic disease therapeutic portfolio, spanning 'Livalo V (pitavastatin + valsartan)', the statin + ezetimibe combination 'Livalozet' introduced in 2021, the fenofibric acid combination 'Livalo Feno' approved in 2025, and the triple-combination antihypertensive 'Livalo Hi (valsartan/amlodipine/pitavastatin).'

The development of "JW0113" is regarded as a pivotal strategic bridge linking the Livalo family directly to the "diabetes space."

In particular, empagliflozin is a benchmark SGLT-2 inhibitor with established efficacy not only in robust glycemic reduction but also in lowering the risk of heart failure and renal complications. Furthermore, compared to other statins, pitavastatin demonstrates a lower risk of new-onset diabetes mellitus (NODM), driving strong prescribing preferences for diabetic patients or individuals at high risk of diabetes. By combining these two agents with ezetimibe, which inhibits intestinal cholesterol absorption, the regimen will provide an optimal therapeutic option in a single pill for patients who have concurrent dyslipidemia and diabetes.

A pharmaceutical industry official said, "While conventional dual-combination therapies like Zemiglo and Rosumet improved dosing convenience, JW0113 is an evolved model that brings three key drugs aligned with the latest clinical treatment guidelines into a single pill," and added, "If JW Pharmaceutical successfully commercializes this triple FDC alongside Livalo in the market, it is expected to secure an unmatched competitive edge across the chronic disease sector."