Comprehensive Report on the Investigational Drug YYC-506

I. Introduction to YYC-506

YYC-506 is an investigational small molecule pharmaceutical agent, classified as an antihyperlipidemic, currently under development by the South Korean firm Yooyoung Pharm Co. Ltd..[1] The compound has been designated as a New Molecular Entity (NME).[2] The primary therapeutic objective for YYC-506 is the management of complex dyslipidemias. It is specifically being evaluated for patients who have achieved adequate control of their low-density lipoprotein cholesterol (LDL-C) levels through statin therapy, typically with atorvastatin, but continue to exhibit elevated plasma triglycerides (TG) and/or sub-optimal levels of high-density lipoprotein cholesterol (HDL-C).[3] This focus addresses a significant residual cardiovascular risk often observed in patients despite effective LDL-C lowering.

Yooyoung Pharm Co. Ltd. is identified as both the originator and the sole active organization responsible for the clinical development of YYC-506.[1] The drug is currently in the advanced stages of clinical investigation, having reached Phase 3 trials for the treatment of hyperlipidemias in South Korea. Additionally, there are indications of Phase 2 development for dyslipidemias in the United States, suggesting a potential strategy for broader market introduction pending successful trial outcomes.[1]

The consistent description of YYC-506's target patient population—individuals with controlled LDL-C on atorvastatin but with persistent TG and HDL-C abnormalities—points to a strategic focus on a specific unmet need within contemporary dyslipidemia management.[3] Statins, such as atorvastatin, are foundational for reducing LDL-C and are highly effective in this regard.[7] However, a substantial number of patients treated with statins continue to face residual cardiovascular risk attributable to hypertriglyceridemia and/or low HDL-C levels, a well-recognized challenge in clinical practice.[9] YYC-506's development program is precisely aimed at this "residual risk" demographic. This targeted approach suggests that Yooyoung Pharm is pursuing a defined market segment where existing monotherapies are insufficient. Such a strategy may facilitate clearer regulatory pathways and enhance physician adoption if the drug demonstrates robust efficacy and a favorable safety profile, positioning YYC-506 not merely as another lipid-modifying agent but as a tailored solution for a specific juncture in dyslipidemia care.

II. Drug Profile and Composition

YYC-506 is characterized as a small molecule drug [1] and has been classified as a New Molecular Entity (NME) by some pharmaceutical intelligence services.[2] The NME designation is noteworthy. Typically, atorvastatin and fenofibrate, the putative components of YYC-506, are well-established drugs and not considered NMEs individually. A fixed-dose combination (FDC) of existing drugs is generally not classified as an NME unless it incorporates a novel formulation technology or demonstrates a synergistic effect that qualifies it as such under specific regulatory frameworks. The NME status attributed to YYC-506 by AdisInsight [2] might reflect a particular regulatory perspective or a novel aspect of this specific combination or its formulation that is not immediately apparent from high-level data summaries. It is also conceivable that the development code "YYC-506" initially encompassed a broader research program that explored novel chemical entities, even if the lead candidate ultimately materialized as an FDC. However, based on the available clinical trial data, the most direct interpretation is that the FDC itself is being treated as the "entity" under development with this designation.

Substantial evidence from multiple sources strongly indicates that YYC-506 is a fixed-dose combination (FDC) of atorvastatin and fenofibrate.

Clinical trial NCT04874129 is explicitly titled "Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506" and its stated purpose includes evaluating "YYC506 and concomitant administration of YYC506-T and YYC506-A".1

Furthermore, the completed Phase 1 clinical trial NCT04874142 was designed to assess the "Safety and Pharmacokinetic Drug-drug Interaction of YYC506-T and YYC506-A".1

Corroborating these clinical trial descriptions, Korean news reports have explicitly stated that Yooyoung Pharmaceutical is developing an atorvastatin and fenofibrate combination drug.11 These reports link this FDC development to Yooyoung's YYC-506 program by referencing the same Phase 1 trial (NCT04874129) that compares the FDC (referred to as 'YYC506' or the "complex drug") to the co-administration of its components (YYC506-T and YYC506-A). Crucially, these news sources identify the control drugs used for these components in the trial as GC Biopharma's Lipidyl Supra Tablet (active ingredient: fenofibrate) and Pfizer's Lipitor Tablet 20mg (active ingredient: atorvastatin).11

This triangulation of information strongly implies the following identities:

• YYC506-A is Atorvastatin.
• YYC506-T is Fenofibrate.
• YYC-506 is the Fixed-Dose Combination of Atorvastatin and Fenofibrate.

The therapeutic rationale further supports this conclusion. The patient population targeted in the Phase 3 trial NCT04858308—individuals with LDL-C controlled by atorvastatin but requiring additional management for triglycerides and HDL-C—represents a classic clinical scenario where fenofibrate is added to ongoing atorvastatin therapy.[3] Moreover, Yooyoung Pharmaceutical already markets Pravafenix, an FDC of pravastatin and fenofibrate.[11] The development of an atorvastatin and fenofibrate FDC would be a logical extension of their product pipeline, incorporating a more potent statin.

The alternative names listed for the drug, YYC-506; YYC506-T/YYC506-A [2], clearly refer to the FDC itself (YYC-506) and its constituent active pharmaceutical ingredients (YYC506-T likely being fenofibrate and YYC506-A likely being atorvastatin) as investigated in the early-phase clinical trials. The lack of explicit disclosure of FDC components in some international databases might be attributable to confidentiality maintained during early-stage development or variations in regional reporting requirements.

The specific dosages of atorvastatin and fenofibrate within the YYC-506 FDC are not consistently detailed in the available database summaries. However, the use of Lipitor 20mg as a reference for the atorvastatin component (YYC506-A) in the Korean news reports provides a potential clue.[11] Patent literature for other atorvastatin/fenofibrate FDCs mentions various dosage strengths, such as atorvastatin 40 mg combined with fenofibrate 100 mg.[12] The precise dosage of the components in YYC-506 will be that which is evaluated and established through the ongoing clinical trial program.

III. Mechanism of Action and Pharmacological Rationale

While many general pharmaceutical databases list the mechanism of action (MoA) for YYC-506 as "undefined" or provide no specific details [1], the MoA can be reliably inferred from its composition as an FDC of atorvastatin and fenofibrate.

The atorvastatin component (likely YYC506-A) functions as an HMG-CoA reductase inhibitor. Atorvastatin competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, which is the rate-limiting enzyme in the cholesterol biosynthesis pathway. This inhibition leads to a decrease in intracellular cholesterol concentrations. In response, hepatocytes upregulate the expression of LDL receptors on their cell surfaces, resulting in increased clearance of LDL-cholesterol (LDL-C) from the systemic circulation. Beyond its primary LDL-C lowering effect, atorvastatin also contributes to reductions in plasma triglycerides (TG) and very-low-density lipoproteins (VLDL).[7]

The fenofibrate component (likely YYC506-T) acts as a Peroxisome Proliferator-Activated Receptor alpha (PPARα) activator. The activation of PPARα by fenofibrate modulates the expression of a multitude of genes involved in lipid metabolism. Key molecular effects include an increased synthesis of lipoprotein lipase (LPL), which hydrolyzes triglycerides in VLDL and chylomicrons, and an increased production of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), the primary structural proteins of HDL. Conversely, fenofibrate decreases the synthesis of apolipoprotein C-III (apoC-III), an inhibitor of LPL and hepatic remnant uptake. Collectively, these actions lead to enhanced catabolism of TG-rich lipoproteins, resulting in a significant reduction in plasma TG levels, and an increase in HDL-cholesterol (HDL-C) concentrations. Fenofibrate may also exert a modest LDL-C lowering effect.[7]

The pharmacological rationale for combining atorvastatin and fenofibrate in YYC-506 is to provide a comprehensive and complementary approach to managing mixed dyslipidemia. This combination concurrently addresses all key atherogenic lipid parameters: elevated LDL-C, high TG, and low HDL-C.[9] Atherosclerosis is understood to be driven by multiple lipid abnormalities, not solely elevated LDL-C; high TG and low HDL-C are recognized as independent risk factors for cardiovascular disease.[20] While statins like atorvastatin are first-line therapy for LDL-C reduction, they may not adequately address coexisting hypertriglyceridemia or low HDL-C levels. Fenofibrates, on the other hand, are particularly effective in reducing TG and raising HDL-C. Thus, an FDC such as YYC-506 offers a single-pill therapeutic strategy to manage these multiple lipid abnormalities simultaneously. This is particularly relevant for the target patient population of YYC-506: individuals who exhibit residual hypertriglyceridemia and/or low HDL-C despite achieving LDL-C control with statin monotherapy, a common clinical scenario associated with persistent cardiovascular risk.[3] YYC-506, as an atorvastatin-fenofibrate FDC, is therefore designed for comprehensive lipid management, potentially offering greater cardiovascular risk reduction in patients with mixed dyslipidemia than can be achieved with statin monotherapy alone.

IV. Therapeutic Indications and Target Population

The primary therapeutic indication for YYC-506 is the treatment of hyperlipidemias and dyslipidemias.[1] More specifically, clinical trial descriptions refer to its use in "complex dyslipidemia" [3] or, as inferred from its FDC composition and targeted effects, "mixed hyperlipidemia."

The specific target population for YYC-506, as defined in its Phase 3 clinical trial (NCT04858308), consists of:

• Adult patients, typically aged 19 years or older.[3]
• Individuals whose LDL-cholesterol (LDL-C) levels are adequately controlled through atorvastatin monotherapy, but who concurrently exhibit inadequately controlled triglyceride (TG) levels (i.e., hypertriglyceridemia) and/or low high-density lipoprotein cholesterol (HDL-C) levels.[3]
• This patient demographic often includes individuals with underlying cardiovascular risk factors such as established coronary artery disease (CAD), a history of atherosclerotic ischemic stroke or transient ischemic attack (TIA), peripheral artery disease (PAD), or diabetes mellitus (typically with HbA1c < 9.0% as per trial inclusion criteria).[5]

The focus on this particular patient group highlights an effort to address a common challenge in lipid management. Many patients treated for high LDL-C with statins still carry a significant burden of residual cardiovascular risk due to other lipid abnormalities, primarily elevated triglycerides and low HDL-C. The development of an FDC like YYC-506 offers a practical advantage beyond its combined pharmacological effects. Patients requiring management for multiple lipid parameters often face polypharmacy, which can negatively impact treatment adherence. By combining atorvastatin and fenofibrate into a single tablet, YYC-506 aims to reduce pill burden. This simplification of the treatment regimen has the potential to improve patient adherence, which is crucial for achieving long-term therapeutic goals and cardiovascular risk reduction.[24] This is a well-established rationale for the development of FDCs in chronic conditions requiring multiple medications.

V. Clinical Development Program

Yooyoung Pharmaceutical has implemented a structured clinical development program for YYC-506, progressing from initial Phase 1 studies focusing on drug-drug interactions (DDI) and the pharmacokinetic (PK) profile of the fixed-dose combination (FDC), to a pivotal Phase 3 trial designed to establish its efficacy and safety in the target patient population.

Table 1: Summary of YYC-506 Key Information

Feature	Details	References
Drug Name	YYC-506	User Query
Alternative Names	YYC506-T/YYC506-A	2
Originator/Developer	Yooyoung Pharm Co. Ltd.	1
Drug Type	Small molecule	1
NME Status	Yes	2
Proposed FDC Components	Atorvastatin (likely YYC506-A) and Fenofibrate (likely YYC506-T)	11
Primary Indication	Hyperlipidemias, Dyslipidemias	1
Target Population	Adults with LDL-C controlled on Atorvastatin but with elevated Triglycerides and/or low HDL-C levels	3
Highest Development Phase	Phase 3 (South Korea); Phase 2 (United States)	1

A. Phase 3 Clinical Trial: NCT04858308

The cornerstone of YYC-506's late-stage development is the Phase 3 clinical trial registered under NCT04858308, also identified by the study ID YYPCT_YYC506_301.[3] This trial is sponsored by Yooyoung Pharm Co. Ltd..[1]

Information regarding the trial's status presents some variation across sources. CenterWatch, with its last update on April 20, 2021, listed the trial as "Active - Recruiting".[4] Similarly, TrialScreen also indicated an "Active - Recruiting" status.[6] Korean news articles from March to May 2022 corroborated that recruitment was ongoing for domestic approval purposes.[5] Pharmaceutical databases like Synapse have listed the status as "Unknown status" but provided a trial start date of January 29, 2021.[1] The first patient was reportedly registered on July 7, 2021.[5] There is also a discrepancy in the estimated primary completion date: CenterWatch indicated January 31, 2022 [4], while Korean news sources from March 2022 suggested the trial was expected to continue until February 2023.[5] This difference in timelines should be noted when interpreting the drug's development progress.

The study is designed as a multicenter, randomized, double-blind, active-comparator controlled, parallel-group, double-dummy trial aimed at securing domestic (South Korean) regulatory approval.[3] It aims to enroll 554 adult patients (aged >19 years) diagnosed with complex dyslipidemia. The specific patient profile includes individuals whose LDL-C is adequately controlled by atorvastatin monotherapy but who continue to exhibit inadequately controlled triglyceride and/or HDL-C levels.[3] Inclusion criteria encompass patients with conditions such as coronary artery disease, a history of stroke or TIA, peripheral artery disease, or diabetes (with HbA1c < 9.0%).[5] Exclusion criteria include elevated creatine kinase (CK) levels (typically ≥ 2-3 times the upper limit of normal), uncontrolled hypothyroidism, or severe renal impairment.[3]

The interventions in this trial involve a test group receiving YYC506 plus a placebo (for the active comparator) and a control group receiving an active comparator designated as "YYC506-R" plus a placebo (for YYC506).[3] Given the trial's objective—to demonstrate the benefit of YYC-506 (an atorvastatin/fenofibrate FDC) in patients already on atorvastatin for LDL-C control but needing further TG/HDL-C management—the active comparator YYC506-R is highly likely to be atorvastatin monotherapy. The trial is essentially designed to evaluate the incremental benefit of adding fenofibrate (delivered via the YYC-506 FDC) to the existing atorvastatin regimen. The double-dummy design is employed to maintain blinding when comparing an FDC to one of its components or another active treatment, necessitating the use of corresponding placebos for each active arm.[5]

The primary efficacy outcome measure is the percentage change from baseline in non-HDL-C levels at 12 weeks of treatment.[5] Secondary outcome measures include changes in other lipid parameters (such as TG, HDL-C, LDL-C, ApoB) and comprehensive safety assessments.[5] The trial is being conducted at multiple centers across South Korea, with 35 principal investigators involved. Notable sites include Chonbuk National University Hospital, Seoul National University Hospital, and Seoul National University Bundang Hospital.[3] As of the latest available information (May 2022 from Korean news sources), no definitive efficacy or safety results from this pivotal Phase 3 trial have been publicly released, and the trial is understood to be ongoing.

Table 2: Detailed Information for Clinical Trial NCT04858308

Parameter	Details
NCT ID	NCT04858308
Official Title	Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506
Sponsor	Yooyoung Pharm Co. Ltd.
Phase	Phase 3
Status	Active - Recruiting / Unknown status (discrepancies noted across sources)
Start Date	January 29, 2021 (First patient: July 7, 2021)
Est. Primary Completion Date	January 31, 2022 (CenterWatch) / February 2023 (Korean news sources) - Discrepancy noted
Purpose	To evaluate the efficacy and safety of YYC506 in patients with complex dyslipidemia where LDL-C is controlled by Atorvastatin, but TG and HDL-C levels are not.
Study Design	Multicenter, randomized, double-blind, active-comparator controlled, parallel-group, double-dummy.
Patient Population	554 adults (>19 years) with complex dyslipidemia on Atorvastatin monotherapy with inadequately controlled TG and/or HDL-C. Includes patients with CAD, stroke, PAD, DM.
Interventions	Test Group: YYC506 + Placebo (for comparator). Control Group: YYC506-R (likely Atorvastatin monotherapy) + Placebo (for YYC506).
Primary Outcome Measure	Percent change from baseline in non-HDL-C at 12 weeks.
Secondary Outcome Measures	Changes in other lipid parameters (TG, HDL-C, LDL-C, ApoB, etc.), safety assessments.
Locations	Multiple centers in South Korea (e.g., Chonbuk National University Hospital, Seoul National University Hospital, SNU Bundang Hospital).

B. Phase 1 Clinical Trial: NCT04874129

Prior to the Phase 3 study, Yooyoung Pharm Co. Ltd. sponsored a Phase 1 clinical trial, NCT04874129, titled "Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506".[1] This trial commenced on January 7, 2021.[1] While some databases list its status as "Unknown status" [1], AdisInsight reported that enrollment had initiated in January 2021.[2] Korean news sources, likely from late 2020 or early 2021, indicated that this trial was expected to run from January to June of that year.[11]

The primary objective of this study was to evaluate the safety and pharmacokinetic (PK) characteristics of the YYC506 FDC when administered as a single entity, compared to the concomitant administration of its individual components, identified as YYC506-T (Fenofibrate) and YYC506-A (Atorvastatin).[1] The trial enrolled 60 healthy adult volunteers.[11] The interventions involved comparing the YYC506 FDC against the co-administration of YYC506-T and YYC506-A. Notably, the control drugs used to benchmark these individual components were specified as GC Biopharma's Lipidyl Supra Tablet (fenofibrate) and Pfizer's Lipitor Tablet 20mg (atorvastatin calcium trihydrate).[11] This study design is typical for FDC development, serving as a bridging study to ensure the PK profile of the combined formulation is acceptable and comparable to its individual active ingredients administered together. Successful completion of such a trial is a critical step, providing essential PK data that supports the FDC's formulation and its progression into larger efficacy trials.

Table 3: Detailed Information for Clinical Trial NCT04874129

Parameter	Details
NCT ID	NCT04874129
Official Title	Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506
Sponsor	Yooyoung Pharm Co. Ltd.
Phase	Phase 1
Status	Unknown status / Enrollment initiated January 2021
Start Date	January 7, 2021
Purpose	To evaluate the safety and pharmacokinetic characteristics of YYC506 (FDC) compared to the concomitant administration of its components (YYC506-T and YYC506-A).
Study Design	Pharmacokinetic comparison study.
Patient Population	60 healthy adult volunteers.
Interventions	YYC506 (FDC) vs. (YYC506-T [Fenofibrate component] + YYC506-A [Atorvastatin component]). Reference drugs for components: Lipidyl Supra (Fenofibrate), Lipitor 20mg (Atorvastatin).

C. Phase 1 Clinical Trial: NCT04874142 (Completed)

The earliest clinical study in the YYC-506 development program detailed in the provided materials is NCT04874142, titled "Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A".[1] This trial was also sponsored by Yooyoung Pharm Co. Ltd..[1]

This Phase 1 study is reported as completed.[1] It commenced on November 20, 2019 [1], and was completed on March 23, 2020.[2] The objective was to evaluate the safety and pharmacokinetic drug-drug interactions (DDI) between YYC506-T (the fenofibrate component) and YYC506-A (the atorvastatin component) when administered to healthy volunteers.[1] Understanding the DDI potential between two drugs is a fundamental prerequisite before combining them into an FDC. Both atorvastatin (primarily metabolized by CYP3A4) and fenofibrate (metabolized via glucuronidation, and a weak inhibitor of CYP2C9 and CYP2C19) have known metabolic pathways and interaction profiles. Co-administration can, for instance, increase the risk of myopathy.[19]

While specific results from NCT04874142 are not detailed in the provided snippets, the successful completion of this DDI study and the subsequent progression of the YYC-506 FDC program to further Phase 1 studies (NCT04874129) and then to Phase 3 (NCT04858308) imply that no prohibitive drug-drug interactions were identified, or that any observed interactions were considered manageable within a therapeutic context. This study provided foundational safety and pharmacokinetic data regarding the co-administration of the active ingredients intended for the YYC-506 FDC.

Table 4: Detailed Information for Clinical Trial NCT04874142 (Completed)

Parameter	Details
NCT ID	NCT04874142
Official Title	Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A
Sponsor	Yooyoung Pharm Co. Ltd.
Phase	Phase 1
Status	Completed
Start Date	November 20, 2019
Completion Date	March 23, 2020
Purpose	To evaluate the safety and pharmacokinetic drug-drug interactions between YYC506-T and YYC506-A.
Study Design	Drug-drug interaction study.
Patient Population	Healthy volunteers.
Interventions	YYC506-T (Fenofibrate component) and YYC506-A (Atorvastatin component).

VI. Regulatory Status and Outlook

YYC-506 is currently an investigational drug under active clinical development. The pivotal Phase 3 trial, NCT04858308, is specifically designed to support an application for domestic (South Korean) marketing approval from the Ministry of Food and Drug Safety (MFDS).[5] As an investigational agent, YYC-506 does not yet have an approved first marketing date.[1] The MFDS has well-defined regulatory pathways for the approval of new drugs and FDCs.[28] Recent reports from the MFDS indicate a trend of approvals for hyperlipidemia combination drugs, particularly those including ezetimibe, suggesting a generally receptive regulatory environment in South Korea for FDCs in this therapeutic category.[30]

The patent situation for YYC-506 presents some ambiguity based on the available information. While some database entries suggest a large number of medical patents associated with YYC-506 (though requiring login for specifics) [1], Yooyoung Pharm Co. Ltd.'s organizational profile on the same platform indicates "0 Patents (Medical)".[32] This discrepancy could arise from various factors, such as patents being held by subsidiary entities, being in the application stage rather than granted, or the drug-specific search pulling a broad net of related patents. For an FDC of known compounds like atorvastatin and fenofibrate, patent protection would typically focus on novel aspects of the formulation, specific component ratios, manufacturing processes, or new medical uses rather than the active ingredients themselves. Generic patents for atorvastatin-fenofibrate FDC formulations do exist [33], but their direct linkage to Yooyoung's YYC-506 is not established in the provided documents. The precise intellectual property protection for YYC-506 remains a critical factor for its future commercial viability and is not fully clarified by the current data.

In terms of market positioning, YYC-506 is aimed at a distinct unmet clinical need: patients with mixed dyslipidemia whose lipid profiles are not adequately managed by atorvastatin monotherapy alone, specifically concerning elevated TG and/or low HDL-C levels.[3] As an FDC of atorvastatin and fenofibrate, YYC-506 will likely compete with the practice of co-prescribing these individual agents and with other existing lipid-lowering FDCs. Yooyoung Pharmaceutical's prior experience in marketing Pravafenix (an FDC of pravastatin and fenofibrate) [11] provides them with established market understanding and strategic leverage in the dyslipidemia sector. The development of an FDC incorporating atorvastatin, which is generally considered a more potent LDL-C lowering statin than pravastatin, represents a strategic enhancement to Yooyoung's dyslipidemia portfolio. This allows the company to offer a combination therapy potentially suitable for patients requiring more intensive LDL-C management or those already stabilized on atorvastatin.

Successful completion of the Phase 3 trials, demonstrating convincing efficacy and safety, could position YYC-506 as a significant product for Yooyoung Pharm within the South Korean hyperlipidemia market. Furthermore, the notation of Phase 2 development for dyslipidemias in the United States [1] suggests ambitions for international market entry, contingent upon further clinical development and regulatory approvals in those regions.

VII. Summary and Key Considerations

YYC-506, an investigational drug developed by Yooyoung Pharm Co. Ltd., is currently in Phase 3 clinical trials. Evidence strongly suggests that YYC-506 is a New Molecular Entity formulated as a fixed-dose combination (FDC) of atorvastatin (likely designated YYC506-A) and fenofibrate (likely designated YYC506-T). Its primary therapeutic target is patients with complex or mixed dyslipidemia who, despite achieving LDL-cholesterol control with atorvastatin monotherapy, exhibit persistent hypertriglyceridemia and/or low HDL-cholesterol levels.

The key strength of YYC-506 lies in its potential to address a specific and recognized unmet clinical need within dyslipidemia management. The combination of atorvastatin and fenofibrate offers a pharmacologically rational approach to comprehensively manage multiple lipid abnormalities (LDL-C, TG, and HDL-C). As an FDC, YYC-506 also holds the promise of improved patient adherence by reducing pill burden compared to the co-prescription of individual agents. This development builds upon Yooyoung Pharmaceutical's existing presence and experience in the dyslipidemia FDC market with Pravafenix.

However, several areas require further information and clarification for a complete assessment of YYC-506. These include:

• Definitive public confirmation of the exact dosages of atorvastatin and fenofibrate within the YYC-506 FDC.
• A more detailed explanation for its NME designation, particularly if it is an FDC of two established drug substances.
• Publicly available, detailed results from the completed Phase 1 drug-drug interaction trial (NCT04874142) and the Phase 1 FDC pharmacokinetic trial (NCT04874129).
• The ongoing status and, critically, the eventual efficacy and safety results from the pivotal Phase 3 trial (NCT04858308). This includes clarification of the precise identity and therapeutic performance of the active comparator, YYC506-R (presumed to be atorvastatin).
• A clear delineation of the patent landscape and intellectual property protection surrounding YYC-506.
• Updates on the progress of its Phase 2 development program in the United States.

The overall outlook for YYC-506 appears promising, particularly within the South Korean market initially. If the ongoing Phase 3 trials yield positive results demonstrating a favorable efficacy and safety profile, YYC-506 could become a valuable treatment option for a significant segment of patients with dyslipidemia who require more than statin monotherapy. Its ultimate success will be contingent upon its clinical performance relative to the co-administration of its individual components, its comparison with other available FDCs, and its ability to demonstrate a compelling value proposition. The dyslipidemia market is characterized by the availability of effective generic monotherapies and various FDCs. While the current Phase 3 trial focuses on lipid modification (non-HDL-C) as a primary endpoint, which is a recognized surrogate marker, the long-term impact on cardiovascular outcomes would be a subject of further interest for broader clinical positioning. The convenience and potential adherence benefits of an FDC are significant, but these will be weighed by clinicians and payers against the overall evidence base and cost-effectiveness in a competitive therapeutic area.

Works cited

1. YYC-506 - Drug Targets, Indications, Patents - Synapse, accessed May 24, 2025, https://synapse.patsnap.com/drug/39286e4d770f4df993b8fb3447c51f5a
2. YYC 506 - AdisInsight, accessed May 24, 2025, https://adisinsight.springer.com/drugs/800063548
3. Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506., accessed May 24, 2025, https://ctv.veeva.com/study/phase-3-trial-to-evaluate-the-efficacy-and-safety-of-yyc506
4. Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506. - CenterWatch, accessed May 24, 2025, https://www.centerwatch.com/clinical-trials/listings/NCT04858308/phase-3-trial-to-evaluate-the-efficacy-and-safety-of-yyc506
5. '제약 임상은...ing'...유영제약 '고지혈증치료제' - 뉴스더보이스헬스케어, accessed May 24, 2025, https://www.newsthevoice.com/news/articleView.html?idxno=25673
6. Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506, accessed May 24, 2025, https://app.trialscreen.org/trials/phase-3-dyslipidemias-to-evaluate-efficacy-safety-yyc506-trial-nct04858308
7. Pharmacotherapy for Dyslipidemia Overview - Calgary Guide, accessed May 24, 2025, https://calgaryguide.ucalgary.ca/pharmacotherapy-for-dyslipidemia-overview/pharmacotherapy-for-dyslipidemia-overview/
8. Lipid-Lowering Drugs | Basic Concepts in Pharmacology: What You Need to Know for Each Drug Class, 5e | AccessMedicine, accessed May 24, 2025, https://accessmedicine.mhmedical.com/Content.aspx?bookid=2147§ionid=161351581
9. Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy - MedPath Clinical Trial Search, accessed May 24, 2025, https://trial.medpath.com/clinical-trial/4c94399b5b128808
10. Triglyceride Lowering Drugs - Endotext - NCBI Bookshelf, accessed May 24, 2025, https://www.ncbi.nlm.nih.gov/books/NBK425699/
11. 유영제약, 200억 '프라바페닉스' 도전에 후발약으로 맞불 - 히트뉴스, accessed May 24, 2025, http://www.hitnews.co.kr/news/articleView.html?idxno=32225
12. Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study - PubMed, accessed May 24, 2025, https://pubmed.ncbi.nlm.nih.gov/20110022/
13. Mechanisms of triglyceride-lowering effect of an HMG-CoA reductase inhibitor in a hypertriglyceridemic animal model, the Zucker obese rat - PubMed, accessed May 24, 2025, https://pubmed.ncbi.nlm.nih.gov/1552226/
14. Caduet (amlodipine / atorvastatin): Uses, Side Effects, Dosage & Reviews - GoodRx, accessed May 24, 2025, https://www.goodrx.com/caduet/what-is
15. Pravastatin sodium/Fenofibrate - Drug Targets, Indications, Patents - Patsnap Synapse, accessed May 24, 2025, https://synapse.patsnap.com/drug/396100773c7e4a349b79646855cde658
16. Hypertriglyceridemia Therapy: Past, Present and Future Perspectives - MDPI, accessed May 24, 2025, https://www.mdpi.com/1422-0067/25/17/9727
17. Mode of action of fibrates in the regulation of triglyceride and HDL-cholesterol metabolism - PubMed, accessed May 24, 2025, https://pubmed.ncbi.nlm.nih.gov/16511610/
18. Efficacy and Safety of Fenofibrate-Statin Combination Therapy in Patients With Inadequately Controlled Triglyceride Levels Despite Previous Statin Monotherapy: A Multicenter, Randomized, Double-blind, Phase IV Study - PubMed, accessed May 24, 2025, https://pubmed.ncbi.nlm.nih.gov/34518033/
19. Atorvastatin+fenofibrate: Uses, Side Effects and Medicines | Apollo Pharmacy, accessed May 24, 2025, https://www.apollopharmacy.in/salt/Atorvastatin+fenofibrate
20. Update on the Benefits and Mechanisms of Action of the Bioactive Vegetal Alkaloid Berberine on Lipid Metabolism and Homeostasi, accessed May 24, 2025, https://ucalgary.scholaris.ca/bitstreams/853564da-b5e3-4c52-bae6-f1a913f42886/download
21. High-Density Lipoprotein Modifications: A Pathological Consequence or Cause of Disease Progression? - PubMed Central, accessed May 24, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC7759904/
22. Hypertriglyceridemia: Pathophysiology, Role of Genetics, Consequences, and Treatment - Endotext - NCBI Bookshelf, accessed May 24, 2025, https://www.ncbi.nlm.nih.gov/books/NBK326743/
23. Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial - PubMed, accessed May 24, 2025, https://pubmed.ncbi.nlm.nih.gov/29223557/
24. Efficacy of a fixed dose combination of irbesartan and atorvastatin (rovelito®) in Korean adults with hypertension and hypercho - Dove Medical Press, accessed May 24, 2025, https://www.dovepress.com/getfile.php?fileID=48018
25. Lipid‐Lowering Effect and Safety of Ezetimibe and Atorvastatin 5 mg in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: A Randomized, Double‐Blind, Parallel, Multicenter, Phase 3 Clinical Trial - PMC, accessed May 24, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC12070249/
26. Efficacy and Safety of High-Dose Atorvastatin in Moderate-to-High Cardiovascular Risk Postmenopausal Korean Women with Dyslipidemia, accessed May 24, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC7379073/
27. Drug Interactions between atorvastatin and fenofibrate - Drugs.com, accessed May 24, 2025, https://www.drugs.com/drug-interactions/atorvastatin-with-fenofibrate-276-0-1071-0.html
28. Korean Ministry of Food and Drug Safety (MFDS) Approval Processes - OMC Medical, accessed May 24, 2025, https://omcmedical.com/korean-ministry-of-food-drug-safety-approval-processes/
29. Ministry of Food and Drug Safety>Our Works>Drugs>Approval Process, accessed May 24, 2025, https://www.mfds.go.kr/eng/wpge/m_17/denofile.do
30. 2022 Drug Approval Report, accessed May 24, 2025, https://www.mfds.go.kr/eng/brd/m_19/down.do?brd_id=eng0004&seq=70438&data_tp=A&file_seq=1
31. 2023 Drug Approval Report, accessed May 24, 2025, https://www.mfds.go.kr/eng/brd/m_19/down.do?brd_id=eng0004&seq=70439&data_tp=A&file_seq=1
32. Yooyoung Pharm Co. Ltd. - Drug pipelines, Patents, Clinical trials - Patsnap Synapse, accessed May 24, 2025, https://synapse.patsnap.com/organization/f8408a10b0cfd7df709428a92dd0a1b1
33. Compositions comprising fenofibrate and atorvastatin - Justia Patents, accessed May 24, 2025, https://patents.justia.com/patent/20070009603
34. WO2006037344A1 - Pharmaceutical compositions comprising fenofibrate and atorvastatin - Google Patents, accessed May 24, 2025, https://patents.google.com/patent/WO2006037344A1/en