At the ICDM 2026 conference, Handok (KRX: 001780) presented Phase 3 clinical trial results showing that adding its DPP-4 inhibitor teneligliptin to a regimen of metformin and empagliflozin reduced HbA1c by approximately 0.7% over 24 weeks in adults with type 2 diabetes.
The Bottom Line
- Clinical Efficacy: Teneligliptin added to metformin and empagliflozin lowered HbA1c by 0.7% compared to placebo, with statistical significance established by week 4.
- Market Context: The readout lands as South Korea’s outpatient diabetes prescription market approaches the threshold of passing 2조원, driven by high-cost combination therapies and SGLT-2/DPP-4 drug class competition.
- Safety Profile: Adverse event rates were comparable between the active treatment and placebo arms, with no severe hypoglycemia or serious drug-related adverse reactions reported.
Phase 3 Trial Design and Glycemic Outcomes
MEDI:GATE NEWS reported that Handok showcased the TERA304 and TERA305 study data at the Korean Diabetes Association’s International Congress ICDM 2026. The trials evaluated patients whose blood glucose remained uncontrolled despite concurrent metformin and empagliflozin therapy. TERA304 evaluated 235 patients taking 10 mg of empagliflozin, while TERA305 enrolled 214 patients on 25 mg of empagliflozin.
Both studies utilized a multi-center, randomized, double-blind, placebo-controlled architecture. At 24 weeks, the primary endpoint demonstrated a significant HbA1c reduction of approximately 0.7% in the teneligliptin groups relative to placebo (p<0.0001). Subgroup analysis revealed that patients with a baseline HbA1c of 8.0% or higher experienced an average reduction of 0.97% in TERA304 and 0.90% in TERA305. Furthermore, 59.5% of TERA304 participants and 58.1% of TERA305 participants achieved a target HbA1c below 7.0%.
Competitive Positioning in the South Korean Diabetes Market
The presentation at ICDM 2026 occurs against a backdrop of intensified portfolio expansion across domestic and multinational pharmaceutical houses. According to coverage by Maeil Business Newspaper, South Korea’s outpatient diabetes prescription market is poised to surpass 2조원, propelled by a structural shift toward high-cost innovative drugs and multi-drug combinations. Major market participants are actively positioning their pipelines to capture share in this expanding landscape, while rising active pharmaceutical ingredient costs and heightened market rivalry present emerging risk factors.
Concurrently, Medical News reported that rival domestic firms showcased extensive clinical datasets at the same congress. Dong-A ST highlighted the 10-year clinical trajectory of its own DPP-4 inhibitor, evogliptin (marketed as Suganon), alongside switching studies designed to demonstrate blood glucose reductions when patients transition from alternative DPP-4 inhibitors. Meanwhile, Daewoong Pharmaceutical emphasized the insulin resistance improvements of its proprietary SGLT-2 inhibitor, enavogliflozin (Envlo), through the ENHANCE-M trial.
Handok originally commercialized teneligliptin as a monotherapy under the brand name Tenelia and as a fixed-dose combination with metformin as Tenelia M in 2015. The latest TERA305 open-label extension data, which tracked patients out to 52 weeks, confirms that the glycemic durability of teneligliptin remains stable even when treatment is extended or when patients cross over from placebo to active therapy.
Broader Pipeline Showcases and Metabolic Comparisons at ICDM 2026
During the same congress, LG Chemical’s Zemimet led high-cost diabetes treatments with annual prescription sales in the 1000억원대 range, while Hanmi Pharmaceutical advanced its GLP-1 metabolic disease pipeline with agents such as efpeglenatide. Eli Lilly’s Mounjaro was also highlighted as a prominent GLP-1 injectable driving prescription expansion through weight loss efficacy.
In comparative evaluations presented at the exhibition, Daewoong Pharmaceutical’s ENHANCE-M study evaluated patients on metformin combination therapy, observing HOMA-IR insulin resistance index changes of -1.85 for 0.3mg of enavogliflozin and -1.31 for 10mg of dapagliflozin. The trial also recorded weight reductions of 3.77 kg and 3.58 kg, alongside systolic blood pressure decreases of 5.93 mmHg and 6.57 mmHg across the respective cohorts.
Dong-A ST detailed its ongoing product evolution, which included reducing tablet sizes for Sugamet twice between 2017 and 2020 and significantly shrinking the dimensions of the three-component Sugatree triple combination tablet to facilitate patient swallowing. This line expansion follows the prior commercialization of the metformin combination Sugamet Sustained-Release and the SGLT-2 inhibitor combination Sugadapa.
