Generic 'Trubuddy' development has begun...SGLT2+TZD

Sinil Pharmaceutical has begun developing 'SIL1238,' a combination of dapagliflozin and pioglitazone

Early development ahead of PMS expiration in August, 2029…latecomer pharmaceutical companies are expected to join

Expanded reimbursement for SGLT-2i+TZD combination therapy and rising prescription demand due to complementary synergy

Product photo of Trubuddy Tab

Generic development for the rapidly growing type 2 diabetes combination therapy 'Trubuddy Tab' has begun. Developed by Boryung, Trubuddy is a dual-combination drug combining the SGLT-2 inhibitor dapagliflozin and the TZD pioglitazone, and generic development appears to have begun as prescriptions for SGLT2 + pioglitazone combination theraphy have recently increased, with a target goal for expiration of the original drug's re-examination period.

According to the pharmaceutical industry sources on the 23rd, the Ministry of Food and Drug Safety (MFDS) approved an investigational new drug (IND) application on the 16th for a bioequivalence evaluation between Sinil Pharmaceutical's 'SIL1238' and 'SIL1238_R'.

This bioequivalence study will compare pharmacokinetic characteristics and safety after a single oral dose under fasting conditions in 44 healthy adults. The primary evaluation endpoints are the maximum plasma concentration and the area under the plasma concentration-time curve of dapagliflozin and pioglitazone. Currently, Trubuddy is the only reference drug for the dapagliflozin + pioglitazone combination.

Trubuddy is a dual combination therapy combining 'dapagliflozin', an SGLT-2 inhibitor that promotes glucose excretion in the kidneys, and 'pioglitazone', a TZD (thiazolidinedione) drug that improves insulin resistance. With complementary blood glucose-lowering effects through different mechanisms of action, it stands out in the prescription market.

The combination of the two classes is evaluated as one of the 'best combinations' in clinical practice. This is because it not only maximizes blood glucose-lowering effects through different mechanisms, but the osmotic diuresis and weight-loss effects of the SGLT-2 inhibitor also offset the risks of weight gain and edema, which are common side effects of TZDs.

By combining the cardiovascular and renal protective benefits of both active ingredients, it creates a powerful synergy for diabetes patients with accompanying metabolic diseases.

In particular, as the national health insurance reimbursement criteria for diabetes combination therapies were significantly expanded, demand for this combination increased significantly. Starting in April 2023, health insurance reimbursement for co-administering SGLT-2 inhibitors and TZDs was officially recognized, which catalyzed prescription demand to shift toward single-pill combination drugs that dramatically improved dosing convenience.

In fact, according to pharmaceutical production performance statistics, as of 2025, Trubuddy recorded KRW 6.1 billion for the 10/15mg strength and KRW 4.5 billion for the 10/30mg strength, achieving a combined production performance of KRW 10.6 billion. This means it has surpassed KRW 10 billion, which is commonly considered the benchmark for a blockbuster in the pharmaceutical industry.

The identical active ingredient is currently on the market and is held by Jeil Pharmaceutical, YooYoung Pharmaceutical, Daewoong Bio, and Hutecs Korea Pharmaceutical. Among these, Jeil Pharmaceutical and Daewoong Bio have both the 10/15mg and 10/30mg doses, while Hutecs Korea Pharmaceutical and YooYoung Pharmaceutical have secured only the 10/15mg dose.

The post-marketing surveillance (PMS, drug re-examination) expiration date for Trubuddy, approved in August 2023, is August 28, 2029. Sinil Pharmaceutical's preemptive approval for a bioequivalence study with about three years remaining until the expiration date is interpreted as a strategic move to secure an early approval schedule targeting the rapidly growing market size.

A pharmaceutical industry official commented, "As clinical preference for the combination of an SGLT-2 inhibitor and a TZD increases in the diabetes combination therapy market, the prescription sales of Trubuddy are rapidly growing," adding, "Generic development participation by latecomer pharmaceutical companies aiming for an early launch timed to the expiration of the re-examination period will follow one after another."