Overview of Fixed-Dose Combination Drug Approvals in South Korea – March 2025

With continuous innovation shaping the global pharmaceutical landscape, fixed-dose combination (FDC) drugs are gaining increasing attention for their advantages in enhancing therapeutic efficacy, simplifying treatment regimens, and improving patient adherence. In March 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) approved a total of 6 new FDCs across multiple therapeutic areas, including cardiovascular, metabolic, and neuropsychiatric diseases. These approvals include both reformulated combinations of existing active pharmaceutical ingredients and novel branded generics, reflecting the country's ongoing efforts to encourage pharmaceutical innovation and patient-centric drug development. This article provides an overview of the newly approved FDCs in South Korea during March, highlighting their indications, compositions, unique features, and the pharmaceutical companies behind them to illustrate the current trends in Korea’s fixed-dose combination market.

1. Telmisartan/Rosuvastatin Calcium/Amlodipine Besylate/Ezetimibe

Telmisartan/Rosuvastatin Calcium/Amlodipine Besylate/Ezetimibe (brand name: NUVOROZET) is a four-component fixed-dose combination cardiovascular drug developed by Chong Kun Dang Pharmaceutical of South Korea. It was first approved in South Korea on March 21, 2025, for the combination treatment of essential hypertension, hypercholesterolemia, and associated cardiovascular risk. The drug integrates four small-molecule components with complementary mechanisms of action: telmisartan (an angiotensin II receptor blocker, ARB), rosuvastatin calcium (an HMG-CoA reductase inhibitor or statin), amlodipine besylate (a calcium channel blocker), and ezetimibe (a cholesterol absorption inhibitor). Through synergistic effects, this formulation simultaneously manages blood pressure, lowers low-density lipoprotein cholesterol (LDL-C), and reduces the risk of atherosclerosis progression. It is particularly suitable for patients requiring multi-drug therapy, simplifying regimens to improve adherence. This is the first domestically developed four-in-one cardiovascular FDC drug in South Korea.

The drug provides comprehensive cardiovascular protection via the synergistic mechanisms of its four components:

Telmisartan blocks the binding of angiotensin II to the AT1 receptor, inhibiting vasoconstriction and aldosterone secretion, thereby lowering blood pressure and improving cardiac remodeling.

Rosuvastatin calcium inhibits HMG-CoA reductase, reducing cholesterol synthesis and upregulating LDL receptor expression, significantly lowering LDL-C while modestly raising high-density lipoprotein cholesterol (HDL-C).

Amlodipine besylate blocks calcium influx into vascular smooth muscle cells, promoting vasodilation, reducing peripheral resistance, and lowering blood pressure.

Ezetimibe inhibits the NPC1L1 receptor in the intestine, decreasing cholesterol absorption. When combined with statins, it can provide an additional 20–30% reduction in LDL-C.

Together, these agents address the multiple pathophysiological mechanisms of hypertension and hyperlipidemia while potentially reducing dose-dependent side effects of individual drugs (e.g., statin-induced myalgia), thus enhancing safety and achieving more comprehensive cardiovascular risk control.

The development of NUVOROZET was driven by the increasing burden of cardiovascular disease in South Korea. Hypertension and hypercholesterolemia are prevalent chronic conditions in the country, often requiring complex multi-drug regimens, which can compromise adherence. By combining four drugs into a once-daily pill, NUVOROZET simplifies the treatment approach, especially for elderly or polypharmacy patients. Although it did not receive special regulatory designation, its rapid approval in 2025 reflects the Korean regulatory agency's emphasis on simplifying complex treatment protocols. As the first domestically developed four-in-one cardiovascular FDC, the drug strengthens South Korea’s position in chronic disease innovation and may promote wider use of combination therapies in the Asian market, particularly in resource-limited settings or populations with low treatment adherence.

Clinical trial data show that this FDC significantly outperforms monotherapies in reducing blood pressure (mean SBP/DBP reduction >20/10 mmHg) and LDL-C (reduction >50%), with good tolerability. The main side effects observed include mild headache, myalgia, or edema. Currently, the approved indications focus on essential hypertension and primary hypercholesterolemia. In the future, it may be extended to patients with diabetes and cardiovascular risk, or for the prevention of atherosclerotic cardiovascular disease (ASCVD), especially in East Asian populations. The development team is also exploring its use in patients with resistant hypertension or those intolerant to conventional treatments, further broadening its clinical applicability.

2. Saccharomyces Boulardii/Calcium Pantothenate

Saccharomyces Boulardii/Calcium Pantothenate (brand name: ProbiomeC) is a probiotic-vitamin combination product developed by BINEX Co., Ltd. in South Korea. It received its first marketing approval on March 20, 2025, in South Korea for the treatment of common gastrointestinal symptoms such as bloating, constipation, diarrhea, and indigestion. This product comprises Saccharomyces boulardii (a probiotic yeast) and calcium pantothenate (the calcium salt of vitamin B5). Saccharomyces boulardii modulates gut microbiota, inhibits pathogenic colonization, and enhances intestinal barrier function, thus alleviating inflammation and dysbiosis. Calcium pantothenate supports energy metabolism and mucosal repair by participating in carbohydrate, fat, and protein metabolism. As the first approved product of its kind in Korea, ProbiomeC aims to relieve digestive symptoms through synergistic effects, particularly in patients with functional gastrointestinal disorders (FGIDs), by simplifying treatment regimens and improving adherence.

The drug’s mechanism of action is based on the complementary roles of its two components:

Saccharomyces boulardii, as a probiotic, directly inhibits the growth of pathogens such as Escherichia coli and Clostridioides difficile, reduces intestinal inflammatory cytokines like TNF-α and IL-8, and promotes the proliferation of beneficial bacteria (e.g., Lactobacillus), thereby restoring gut microbial balance. Its metabolic by-products (e.g., organic acids, antimicrobial peptides) further strengthen intestinal barrier integrity and reduce excessive fluid secretion, helping relieve diarrhea and bloating.

Calcium pantothenate (vitamin B5), a precursor of coenzyme A (CoA), plays a key role in carbohydrate and fat metabolism, supporting intestinal epithelial energy metabolism and mucosal healing. It may also modulate gut neuroendocrine signaling to improve motility, thus alleviating constipation and dyspepsia.

The combination not only addresses microbiota modulation, inflammation reduction, and metabolic support but also provides more stable and comprehensive symptom relief by minimizing the dose-dependent variability often seen with standalone probiotics.

FGIDs—such as irritable bowel syndrome (IBS) and functional dyspepsia—have high prevalence in the Korean population. Existing treatments, including probiotics, laxatives, or acid suppressants, often require combination therapy, leading to poor adherence. By integrating a probiotic and a vitamin into a single formulation, ProbiomeC simplifies the treatment process, particularly for patients with mild to moderate symptoms. Although it has not been granted special regulatory status, its expedited approval in 2025 reflects the Korean authority’s recognition of innovative combination therapies. As BINEX's first gastrointestinal product, ProbiomeC strengthens its position in chronic disease management and may promote the probiotic-nutrient co-formulation model across Asian markets.

Clinical trial data demonstrate that ProbiomeC significantly improves symptoms of bloating, constipation, and diarrhea compared to placebo, with a favorable safety profile (common side effects include mild bloating or transient diarrhea). Its current indication targets common symptoms of FGIDs, but future applications may include IBS, antibiotic-associated diarrhea, and postoperative bowel function recovery. The development team is also exploring its potential role in inflammatory bowel disease (IBD) adjunct therapy, aiming to reduce relapse risk through immune and metabolic modulation. Additionally, the metabolic support from calcium pantothenate may offer new therapeutic strategies for managing digestive complications in patients with malnutrition or metabolic syndrome.

The launch of ProbiomeC marks an innovative breakthrough in combining probiotics with nutritional supplements for gastrointestinal disease management. Its unique formulation addresses gut microbiota, inflammation, and metabolic regulation through a synergistic mechanism, offering a new paradigm for FGID treatment. Although currently approved only in South Korea, its clinical efficacy may pave the way for international registration, particularly in regions with high gastrointestinal disease prevalence such as Asia and Europe. As global demand for natural combination therapies grows, ProbiomeC could emerge as a first-line option for chronic digestive disorders, reducing reliance on traditional medications and improving patient quality of life. Moreover, its development model—integrating probiotics with vitamins—provides the pharmaceutical industry with a low-cost, high-safety strategy, potentially accelerating similar FDC innovations across other chronic disease areas.

3. Saccharomyces Boulardii/D-Biotin

Saccharomyces Boulardii/D-Biotin, marketed under the brand name Flora Seven, is a combination product of probiotics and vitamins developed by BINEX Co., Ltd. in South Korea. It was first approved in South Korea on March 20, 2025, for the treatment of common gastrointestinal symptoms such as abdominal bloating, constipation, diarrhea, and indigestion. The product contains two active ingredients: Saccharomyces boulardii (a drug-resistant probiotic yeast) and D-biotin (vitamin B7). Saccharomyces boulardii helps regulate gut microbiota balance, inhibits pathogenic colonization, and enhances intestinal barrier function, thereby alleviating gut inflammation and microbial dysbiosis. D-biotin (vitamin B7), on the other hand, is involved in cellular energy metabolism, supports mucosal repair, and maintains proper neurological function, working synergistically to relieve digestive symptoms.

The mechanism of action is based on the complementary effects of the two components:

·Saccharomyces boulardii directly inhibits the growth of pathogens (e.g., E. coli, Clostridium difficile), reduces the release of intestinal inflammatory cytokines such as IL-6 and IL-8, and promotes the proliferation of beneficial bacteria like Bifidobacteria, helping restore intestinal microecological balance. Its metabolic by-products (e.g., organic acids and antimicrobial peptides) further strengthen the mucosal barrier and reduce abnormal water secretion, thereby relieving diarrhea and bloating.

·D-biotin (vitamin B7), as a coenzyme, plays a key role in carbohydrate and lipid metabolism, supports energy supply for intestinal epithelial cells, promotes mucosal healing, and may modulate gut neuroendocrine signaling to enhance peristalsis, relieving constipation and indigestion.

The combination not only addresses multiple mechanisms—microbiota regulation, inflammation control, and metabolic support—but also enhances probiotic efficacy through the metabolic support provided by the vitamin, delivering more stable and comprehensive improvement in gastrointestinal symptoms.

The development of this product was driven by the high prevalence of digestive disorders in South Korea. Functional gastrointestinal disorders (such as irritable bowel syndrome and functional dyspepsia) are common in the Korean population, and existing treatments (e.g., probiotics, laxatives, or acid suppressants) often require multiple medications, lowering patient compliance. Flora Seven simplifies therapy by combining probiotics and vitamins into a single formulation, especially suited for patients with mild to moderate symptoms. Although no mention was made of special regulatory designation, the product's rapid approval in 2025 reflects the Korean regulatory authority's recognition of innovative combination therapies.

As a follow-up to BINEX's previous gastrointestinal product ProbiomeC, Flora Seven further reinforces the company's presence in chronic disease management. It may also promote the adoption of probiotic-nutrient combination therapies in Asian markets, particularly among patients with vitamin deficiencies or metabolic impairments.

Clinical trial data show that Flora Seven significantly outperformed placebo in relieving abdominal bloating, constipation, and diarrhea, with a favorable safety profile (common side effects include transient bloating or mild diarrhea). Its current indication targets symptoms of functional gastrointestinal disorders, with potential future expansion into indications such as irritable bowel syndrome (IBS), antibiotic-associated diarrhea, or post-operative bowel function recovery. The development team is also exploring its potential role in adjunctive treatment for inflammatory bowel disease (IBD) by modulating immune and metabolic homeostasis to reduce relapse risk. The metabolic support provided by D-biotin could offer novel intervention strategies for gastrointestinal complications in patients with diabetes or metabolic syndrome, especially in improving enteric nervous system function.

4. Acetaminophen/Chlorpheniramine Maleate/Anhydrous Caffeine/Pseudoephedrine Hydrochloride/DL-Methylephedrine Hydrochloride/Dextromethorphan Hydrobromide Hydrate/Guaifenesin (Pantec)
Pantec is a seven-ingredient combination cold medicine developed by Dong-A Pharmaceutical of South Korea. It was approved for marketing in South Korea on March 18, 2025, for the relief of symptoms associated with the common cold, including fever, headache, cough, nasal congestion, runny nose, and chest tightness. The formulation combines seven classical agents used in cold treatment:

·Acetaminophen (antipyretic and analgesic),

·Chlorpheniramine maleate (antihistamine for nasal symptoms),

·Anhydrous caffeine (enhances analgesic effect),

·Pseudoephedrine hydrochloride and DL-methylephedrine hydrochloride (nasal decongestants),

·Dextromethorphan hydrobromide hydrate (central antitussive), and

·Guaifenesin (expectorant).

This multi-component combination targets a broad range of cold symptoms through synergistic mechanisms, simplifying medication regimens and reducing the likelihood of missed doses or non-compliance that can result from polypharmacy. It is especially suitable for patients who require rapid symptom relief, balancing efficacy with convenience.

Pantec alleviates cold symptoms through the coordinated action of its seven ingredients:

·Acetaminophen inhibits prostaglandin synthesis to provide fever reduction and pain relief.

·Chlorpheniramine, an H₁ receptor antagonist, blocks histamine responses, alleviating nasal congestion and runny nose.

·Pseudoephedrine and DL-methylephedrine act on α-adrenergic receptors to constrict nasal mucosal blood vessels, relieving nasal congestion.

·Caffeine antagonizes adenosine receptors, enhancing antipyretic and analgesic effects and providing alertness.

·Dextromethorphan suppresses the medullary cough center to control dry cough.

·Guaifenesin stimulates bronchial secretions, thinning mucus and promoting its clearance.

The multi-target approach addresses key symptoms such as fever, pain, nasal congestion, cough, and viscous sputum. Moreover, the combination design reduces dose-dependent side effects of individual components (e.g., hypertension from pseudoephedrine or drowsiness from dextromethorphan), optimizing safety while enhancing therapeutic efficacy.

The development of this product responds to clinical needs in South Korea for comprehensive management of common cold symptoms. The common cold often presents with multiple symptoms, and conventional monotherapy requires patients to self-combine drugs, increasing treatment complexity. Pantec simplifies this by integrating seven active ingredients into one formulation, particularly benefiting elderly patients or those needing rapid relief. Although not designated for expedited regulatory review, its swift approval in 2025 underscores the Korean authority’s recognition of convenience and practicality in combination cold therapies.

As an innovative respiratory product by Dong-A Pharmaceutical, Pantec strengthens the company’s competitiveness in the over-the-counter (OTC) market and may drive a broader shift in South Korea from single-agent to multi-component cold medicines, improving medication adherence.

Clinical trial results showed that Pantec significantly outperformed placebo in relieving common cold symptoms (such as fever, nasal congestion, and cough), with good safety (most common side effects were mild dizziness or palpitations). The current indication focuses on the common cold, with potential future applications in influenza symptom relief or allergic rhinitis with accompanying cough/sputum production. Additionally, the research team is exploring its role in managing acute exacerbations of chronic obstructive pulmonary disease (COPD) by improving expectoration and cough control. The stimulant effect of caffeine may also benefit fatigued patients with cold symptoms, broadening its target population.

5. Acetaminophen/Pseudoephedrine Hydrochloride/Guaifenesin/Diphenhydramine Hydrochloride/Riboflavin Sodium Phosphate (PANCOLD-Q)

PANCOLD-Q is a five-ingredient combination cold medication developed by Dongwha Pharm of South Korea. It was approved for marketing in South Korea on March 17, 2025, for the relief of symptoms associated with the common cold, including fever, nasal congestion, cough, excessive phlegm, and allergic symptoms such as rhinorrhea and sneezing.

PANCOLD-Q combines:

·Acetaminophen (which reduces prostaglandin synthesis by inhibiting cyclooxygenase, providing antipyretic and analgesic effects),

·Pseudoephedrine Hydrochloride (a selective α₁-adrenergic receptor agonist that constricts nasal mucosal blood vessels to relieve congestion),

·Guaifenesin (which stimulates bronchial secretions, thinning mucus and promoting expectoration),

·Diphenhydramine Hydrochloride (an H₁-receptor antagonist that alleviates allergy-mediated symptoms like rhinorrhea and sneezing),

·Riboflavin Sodium Phosphate (a phosphorylated form of vitamin B₂ that supports metabolism and may reduce side effects from other ingredients).

This multi-targeted combination comprehensively addresses core symptoms of the common cold such as fever, pain, nasal congestion, cough, and viscous sputum, simplifying the complexity of multi-drug regimens. It balances fast symptom relief with convenient dosing, while riboflavin provides metabolic support to enhance safety—particularly suitable for patients needing rapid symptomatic treatment.

Through synergistic effects, the five components address multiple pathological mechanisms of the common cold:

·Acetaminophen inhibits cyclooxygenase (COX-1/COX-2), reducing prostaglandin E₂ synthesis to lower hypothalamic pyrogenic response and relieve systemic pain—effectively treating fever and muscle aches.

·Pseudoephedrine selectively activates α₁-adrenergic receptors, constricting nasal mucosal vessels to relieve congestion and improve airflow.

·Diphenhydramine, a first-generation H₁-antihistamine, blocks histamine binding to H₁ receptors, suppressing allergy-induced symptoms such as rhinorrhea, sneezing, and nasal vasodilation.

·Guaifenesin increases mucus secretion and reduces viscosity, facilitating expectoration and improving cough.

·Riboflavin Sodium Phosphate, as a coenzyme in mitochondrial redox reactions, supports cellular energy metabolism and may enhance the activity of hepatic cytochrome P450 enzymes—potentially mitigating central nervous system side effects (e.g., drowsiness) and gastrointestinal irritation caused by other components like diphenhydramine.

This synergistic combination targets the core symptoms of colds—fever, pain, nasal congestion, cough, and thick phlegm. Pseudoephedrine and diphenhydramine relieve nasal symptoms through vasoconstriction and antihistamine pathways, respectively. Acetaminophen and guaifenesin address systemic inflammation and respiratory secretions, while riboflavin’s metabolic support reduces the risk of additive adverse effects, enhancing both efficacy and safety in managing complex cold symptoms.

The development of PANCOLD-Q stems from South Korea’s clinical need for comprehensive management of multi-symptom colds. The common cold typically presents with several concurrent symptoms, and traditional monotherapies often require patients to combine drugs themselves, increasing treatment complexity. By integrating five agents into a single formulation, PANCOLD-Q simplifies therapy—particularly beneficial for elderly patients or those requiring rapid symptom relief.

Although no special review designations were noted, the drug's rapid approval (in 2025) reflects regulatory recognition of the convenience and practicality of combination cold medications. As an innovative product in Dongwha’s respiratory disease portfolio, PANCOLD-Q strengthens its competitiveness in the over-the-counter (OTC) market and may signal a shift in South Korea from single-agent to combination cold therapies, improving patient adherence.

Furthermore, the inclusion of riboflavin reflects innovation in side effect management, aligning with the modern pharmaceutical trend of minimizing adverse reactions.

Clinical trials have shown that PANCOLD-Q significantly outperforms placebo in alleviating common cold symptoms such as nasal congestion, cough, and fever, with a favorable safety profile. Common side effects include mild drowsiness, dry mouth, or palpitations. Its current indication is limited to the common cold, but potential future uses may include allergic rhinitis with cough/sputum or acute exacerbations of chronic cough. The research team is also exploring its application in seasonal allergic rhinitis, where the combination of antihistaminic and expectorant effects may reduce nasal symptoms and the risk of secondary respiratory infections.

Riboflavin’s metabolic support properties may offer additional benefits to patients with metabolic syndrome or those on long-term medications, further expanding the target population.

6. Metformin Hydrochloride / Dapagliflozin Propanediol Hydrate / Sitagliptin Hydrochloride Hydrate (Sitaflozinmet)
Sitaflozinmet is a triple-combination oral antidiabetic medication developed by DongKoo Bio & Pharma in South Korea. It was approved on March 12, 2025, for the treatment of type 2 diabetes. The product integrates three components with complementary mechanisms of action:

·Metformin Hydrochloride (a biguanide) lowers fasting blood glucose by reducing hepatic gluconeogenesis, improving peripheral insulin sensitivity, and inhibiting intestinal glucose absorption.

·Dapagliflozin Propanediol Hydrate (an SGLT2 inhibitor) selectively blocks renal glucose reabsorption in the proximal tubules, promoting urinary glucose excretion of approximately 70–100g/day, thereby lowering blood glucose levels, aiding in weight loss, and providing cardiovascular protection.

·Sitagliptin Hydrochloride Hydrate (a DPP-4 inhibitor) inhibits dipeptidyl peptidase-4, prolonging the activity of endogenous incretins (GLP-1 and GIP), enhancing insulin secretion, suppressing glucagon release, and improving β-cell glucose responsiveness.

These three agents act synergistically to address multiple pathophysiological mechanisms in type 2 diabetes:

·Metformin targets hepatic glucose production and insulin resistance.

·Dapagliflozin reduces glucose burden through urinary excretion.

·Sitagliptin enhances incretin function to improve β-cell performance and insulin output.

This multi-targeted design is especially suitable for patients inadequately controlled with mono- or dual therapy, offering a more comprehensive glycemic management approach. Additionally, the weight loss and diuretic effects of SGLT2 inhibitors may counteract the weight gain tendency of metformin, further enhancing metabolic outcomes.

Its cardiovascular and renal protective potential—supported by strong clinical evidence for SGLT2 inhibitors—makes Sitaflozinmet a preferred option for patients requiring intensified treatment and presenting with cardiovascular risk factors, balancing efficacy, safety, and convenience.

Mechanistically:

·Metformin activates the AMPK pathway, inhibits hepatic gluconeogenesis, enhances peripheral glucose uptake, and reduces intestinal absorption of glucose.

·Dapagliflozin, by inhibiting SGLT2, promotes the excretion of 70–100g of glucose per day in urine, directly lowering blood glucose while promoting weight loss and cardiovascular benefits.

·Sitagliptin inhibits DPP-4, prolonging the action of GLP-1 and GIP to enhance postprandial insulin secretion, suppress glucagon, and support β-cell function.

Together, they provide a complementary approach covering insulin sensitivity, β-cell function, incretin activity, and renal glucose excretion. Metformin and sitagliptin address insulin resistance and β-cell dysfunction, respectively, while dapagliflozin reduces glucose load without increasing hypoglycemia risk. The diuretic and weight-reducing effects of the SGLT2 inhibitor may offset potential adverse metabolic effects from the other components, enhancing overall patient benefit.

Conclusion

The fixed-dose combinations approved in March 2025 demonstrate South Korea’s commitment to promoting safe, effective, and user-friendly medications. Whether through synergistic drug pairings or improved dosage forms, these approvals reflect a broader strategy to enhance clinical outcomes and address real-world treatment challenges. For pharmaceutical companies, FDCs also offer strategic opportunities to extend product life cycles and gain competitive advantages in the high-value generic and specialty drug segments. Looking ahead, as precision medicine and individualized treatment strategies evolve, fixed-dose combinations will continue to play a key role in modern therapeutics

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