Comprehensive Report on the Investigational Agent(s) Designated YY-162

I. Executive Summary and Disambiguation of YY-162

A. Introduction to the Ambiguity of "YY-162"

The designation "YY-162" has been associated with at least two distinct investigational pharmaceutical agents, creating a potential for significant confusion within the biomedical research and development landscape. One entity is an oncology drug candidate, described as a tyrosine kinase inhibitor. The other is a combination product containing Ginkgo biloba extract and Ginseng extract, developed by Yuyu Pharma, Inc., for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and related behavioural disorders. The concurrent use of an identical alphanumeric identifier for unrelated compounds, particularly those originating from different developers and targeting vastly different therapeutic areas and patient populations, presents a notable challenge for accurate data tracking, literature review, and database curation. This report aims to meticulously differentiate these two entities, synthesizing available information to provide a clear and comprehensive overview of each.

B. Comparative Overview of Identified YY-162 Entities

To immediately clarify the distinctions between the two agents, a comparative summary is provided below. This table highlights their fundamental differences in development, pharmacological class, mechanism, and therapeutic focus.

Table 1: Comparative Summary of YY-162 Entities

Feature	YY-162 (Oncology)	YY-162 (ADHD - Yuyu Pharma, Inc.)
Developer(s)	A consortium of leading research institutions, including several prestigious universities and pharmaceutical companies 1	Yuyu Pharma, Inc. 2
Drug Type/Class	Small molecule inhibitor; Tyrosine Kinase Inhibitor (TKI) 1	Small molecule drug (per Synapse database classification); Combination of Ginkgo biloba extract (terpenoid-strengthened) and Ginseng extract (ginsenoside Rg3) 2
Mechanism of Action (Brief)	Selectively inhibits specific tyrosine kinases involved in cancer cell growth and proliferation 1	Modulates oxidative stress, dopaminergic neurotransmission, and Brain-Derived Neurotrophic Factor (BDNF) signaling; affects Dopamine Transporter (DAT) and Norepinephrine Transporter (NET) 2
Primary Indication(s)	Solid tumors (e.g., breast, lung, colorectal cancer), particularly those resistant to conventional therapies 1	Attention Deficit Disorder With Hyperactivity (ADHD); Behavioural disorders 2
Highest Reported Development Phase	Early clinical trials (Phase 1) 1	Completed Phase 3 clinical trials; some databases list as "Pending Phase 3" 2

This initial differentiation is critical for interpreting the subsequent detailed sections of this report, each dedicated to one of these distinct investigational agents.

II. YY-162: Investigational Tyrosine Kinase Inhibitor for Oncological Applications

A. Overview and Development Context

This iteration of YY-162 is an investigational new drug candidate being explored for its potential in treating various forms of cancer.[1] Its development is attributed to "a consortium of leading research institutions, including several prestigious universities and pharmaceutical companies".[1] The specific names of these participating entities are not disclosed in the available information.

The nature of development by an unnamed "consortium" is not uncommon for early-stage oncology drugs, particularly those stemming from academic discoveries or early-phase collaborations before a lead pharmaceutical partner assumes primary responsibility or a new biotechnology company is established around the asset. While such consortia can pool diverse expertise, they may also encounter challenges related to fragmented early data dissemination, unified strategic direction, and consistent funding if not robustly managed. The absence of a clearly identified single commercial entity leading development can make tracking progress through conventional channels like company press releases or investor updates more difficult, increasing reliance on scientific publications or conference presentations from the involved institutions, which, in this case, remain unspecified.

B. Pharmacological Profile: Drug Class and Mechanism of Action

YY-162 is classified as a "small molecule inhibitor".[1] Its primary mechanism of action involves the inhibition of specific enzymes known as tyrosine kinases.[1] Tyrosine kinases are integral components of cellular signaling pathways that govern critical processes such as cell division, survival, differentiation, and apoptosis. In many types of cancer, these enzymes exhibit aberrant overactivity or mutations, leading to uncontrolled cell growth and tumor progression.[1]

YY-162 is designed to selectively bind to the ATP-binding site of these target tyrosine kinases. This binding action prevents the phosphorylation events necessary for kinase activation and subsequent downstream signaling, effectively arresting cancer cell proliferation and potentially inducing programmed cell death (apoptosis).[1]

A key characteristic emphasized for this YY-162 is its high selectivity. It is reported to preferentially target cancer cells while sparing normal, healthy cells.[1] This selectivity is attributed to the drug's "unique chemical structure," which purportedly allows it to fit precisely into the ATP-binding pocket of the target enzymes within cancer cells. Such precision is intended to minimize off-target effects, a common source of toxicity in cancer treatments that can lead to collateral damage to healthy tissues.[1] The claim of high selectivity, if substantiated through rigorous preclinical and clinical evaluation, would represent a significant therapeutic advantage, as off-target toxicities are a major limiting factor for many existing cancer therapies, including some older-generation tyrosine kinase inhibitors. The "unique chemical structure" would be the critical differentiating factor underpinning this selectivity, though specifics of this structure are not provided.

C. Therapeutic Rationale and Target Indications

The primary therapeutic indication for this YY-162 is the treatment of solid tumors, with specific examples cited including breast cancer, non-small cell lung cancer (NSCLC), and colorectal cancer.[1] A crucial aspect of its therapeutic rationale is its potential utility against tumors that have developed resistance to conventional therapies such as chemotherapy and radiation, thereby addressing a significant unmet medical need.[1]

The development strategy appears to target specific molecular contexts within these cancers:

• Breast Cancer: Tumors that overexpress the Human Epidermal growth factor Receptor 2 (HER2) protein, a known driver in aggressive forms of the disease.[1]
• Non-Small Cell Lung Cancer (NSCLC): Tumors with Epidermal Growth Factor Receptor (EGFR) mutations, which are often associated with poor prognosis and resistance to existing EGFR inhibitors.[1]
• Colorectal Cancer: Tumors harboring specific mutations in the KRAS gene, which currently present limited targeted treatment options.[1]

The ambition to target diverse oncogenic drivers such as HER2, EGFR, and KRAS with a single agent is noteworthy. Tyrosine kinase inhibitors are typically characterized by their specificity for particular kinases or families of kinases. The broad range of proposed targets for YY-162 might suggest that it inhibits a common downstream signaling node critical to these pathways, or that it is a multi-targeted TKI designed with a specific inhibitory profile against kinases relevant to these mutations, or perhaps that the description is a broad generalization of potential applications being explored in early research. The available information lacks the precision to clarify the exact kinase or kinases inhibited by this YY-162.

The focus on tumors "resistant to conventional therapies" positions YY-162 for use in later lines of treatment.[1] While this addresses a critical need, developing drugs for treatment-resistant populations often involves patient cohorts that are heavily pre-treated and molecularly heterogeneous. Clinical trials in such settings can be challenging due to factors like acquired cross-resistance, patients' poorer performance status, and accumulated co-morbidities, which can complicate the demonstration of significant efficacy.

D. Summary of Preclinical Research

YY-162 is reported to have demonstrated "promising results in preclinical studies".[1] However, specific quantitative data from these preclinical investigations, such as IC50​ values against target kinases, detailed outcomes from in vitro cell line studies, efficacy data from in vivo xenograft models, or comparative performance against existing TKIs, are not provided in the accessible materials. This lack of specific preclinical data limits an in-depth assessment of its early potential beyond the general statement of promise. Such data would be foundational for understanding the strength of evidence that supported its progression into clinical trials.

E. Clinical Development: Focus on Phase 1 Trial Data

This oncological YY-162 is currently in the "early stages of clinical trials," specifically having advanced into Phase 1 trials.[1] Preliminary data emerging from these Phase 1 studies indicate that the drug is "well-tolerated" and exhibits "manageable side effects".[1] Furthermore, there are "signs of clinical activity," with some patients receiving YY-162 having shown "partial responses and stable disease".[1] These early findings suggest that the drug possesses the potential to confer meaningful clinical benefits to cancer patients.

The qualitative nature of this reported Phase 1 data ("well-tolerated," "manageable side effects," "partial responses," "stable disease") is consistent with the objectives of early-phase oncology trials, which primarily focus on safety, dose-finding, and pharmacokinetic profiling. However, the absence of quantitative details—such as specific dose levels tested, dose-limiting toxicities (DLTs) observed, the recommended Phase 2 dose (RP2D), objective response rates (ORR), disease control rates (DCR), or the frequency and grade of specific adverse events—prevents a more robust assessment of its clinical profile at this stage.

Nevertheless, the observation of "partial responses and stable disease" during Phase 1 is an encouraging signal.[1] While efficacy is not the primary endpoint of Phase 1 trials, any evidence of anti-tumor activity is considered a positive indicator and supports further investigation. Such findings often provide the rationale for advancing a drug candidate into Phase 2 trials, where efficacy in specific tumor types is more formally evaluated. No specific Phase 1 trial identifiers (e.g., NCT numbers), patient enrollment numbers, or stratification by tumor types treated in these initial studies are available in the provided information. One source lists "Solid tumour/cancer" for a "YY-162" in "Phase 1/2" without a clear developer link to this specific oncology drug, making its direct attribution uncertain.[4]

F. Current Developmental Status and Future Outlook

The oncology agent YY-162 is described as being in the "early stages of clinical trials" [1], with research activities ongoing. The aspiration is that this compound "will become a valuable addition to the arsenal of cancer therapies, providing new hope for patients with difficult-to-treat cancers".[1] No specific timelines for further development, data release, or potential progression to Phase 2 trials are mentioned.

The general optimism expressed is typical for investigational drugs showing early promise. However, it is important to contextualize this within the broader landscape of oncology drug development, which is characterized by high attrition rates. Many agents that appear promising in early phases may not succeed in later, more definitive trials due to insufficient efficacy, unacceptable toxicity, or other unforeseen challenges. The future trajectory of this YY-162 will heavily depend on the comprehensive quantitative results from its Phase 1 program, the strategic design and successful execution of subsequent Phase 2 trials, the evolving competitive landscape for TKIs, and the sustained commitment and resources of the development consortium.

III. YY-162: Ginkgo Biloba and Ginseng Combination for ADHD (Yuyu Pharma, Inc.)

A. Overview and Originator

Distinct from the oncological compound, a second investigational agent also designated YY-162 has been developed by Yuyu Pharma, Inc., a South Korean pharmaceutical company.[2] This YY-162 is intended for the treatment of Attention Deficit Disorder With Hyperactivity (ADHD) and other behavioural disorders.[2] While composed of herbal extracts, it is classified as a "Small molecule drug" in the Synapse database.[2] This classification may reflect a focus by Yuyu Pharma on specific, purified active small molecule constituents from these extracts, such as ginsenoside Rg3 and particular terpenoids from Ginkgo biloba, rather than utilizing crude, unrefined extracts. This approach would align with modern phytopharmaceutical development, aiming for better standardization, characterization, and potentially enhanced patentability. The description of YY-162 as consisting of "terpenoid-strengthened Ginkgo biloba and ginsenoside Rg3" [2] and as "patented Ginkgo leaf and ginseng extract" [5] further supports this interpretation of a refined, standardized combination product.

B. Composition, Formulation, and Dosage

The Yuyu Pharma YY-162 is a combination product whose core components are Ginkgo biloba extract and Ginseng extract.[2] More specifically, it is formulated with "terpenoid-strengthened Ginkgo biloba and ginsenoside Rg3".[2] The formulation is intended for oral administration, consistent with its use in pediatric populations for ADHD.

Regarding dosage, specific quantitative details for the Phase 3 clinical trials are not extensively provided in most of the available materials. However, news reports from South Korea in late 2011 indicated that Yuyu Pharma received approval from the Korea Food and Drug Administration (KFDA, now Ministry of Food and Drug Safety, MFDS) to modify the dosage regimen for YY-162 to "1일 3회 요법" (three times a day therapy) for its late-stage Phase 3 clinical trial.[5] This suggests an evolution from potentially different or less optimized dosing schedules used in earlier stages of its Phase 3 program (the initial Phase 3 trial, NCT01201187, began in March 2010, while the subsequent trial, NCT01536210, likely the one with the revised regimen, commenced in late 2011/early 2012 [2]). Such adjustments are common during clinical development as more data on a drug's pharmacokinetics, efficacy, and tolerability in humans becomes available. Preclinical studies in mice used a YY-162 dose of 200 mg/kg/day.[10]

C. Proposed Mechanism of Action in Neuropsychiatric Disorders

The therapeutic effects of Yuyu Pharma's YY-162 in ADHD are proposed to arise from its ability to modulate multiple biological pathways. It is suggested to influence "oxidative stress, dopaminergic neurotransmission, and brain-derived neurotrophic factor (BDNF) signaling".[2] These pathways are considered critical in the pathophysiology of ADHD.

Preclinical research, notably a study published in Food and Chemical Toxicology in 2014 by Lee et al. (which included authors from Yuyu Pharma's research center), investigated YY-162 in an Aroclor1254-induced ADHD-like condition in mice and in SH-SY5Y neuroblastoma cells.[2] Key findings from this preclinical work include:

• YY-162 attenuated the Aroclor1254-induced increase in reactive oxygen species (ROS) and the decrease in BDNF levels.[2]
• It mitigated reductions in the expression of phosphorylated TrkB (p-TrkB, the primary receptor for BDNF), BDNF itself, the dopamine transporter (DAT), and the norepinephrine transporter (NET).[2]
• The neuroprotective and behavioral effects of YY-162 were comparable to those of methylphenidate (MP), a standard stimulant medication for ADHD.[2]
• The protective actions of YY-162 were counteracted by K252a, a TrkB antagonist, underscoring the importance of the BDNF/TrkB signaling pathway in its mechanism.[2] The authors concluded that "interactive signaling between antioxidant potential and BDNF/TrkB receptor for the positive modulation of the DAT and NET is important for YY162-mediated protective activities".[2]

This multi-target mechanism, involving antioxidant effects, neurotrophic factor modulation, and neurotransmitter system regulation, is characteristic of many herbal medicines. Such pleiotropy could offer a broader therapeutic impact than single-target agents. However, it also presents challenges in fully elucidating the specific contribution of each pathway and each active constituent within the complex mixture to the overall clinical effect, as well as in ensuring consistent batch-to-batch activity and predicting potential drug-drug interactions.

A significant claim from the preclinical studies was that YY-162 exhibited "negligible behavioral side effects" when compared to methylphenidate in animal models.[2] If this favorable side effect profile were to translate to human subjects, it would represent a major clinical advantage, as common stimulant medications for ADHD can be associated with adverse effects such as insomnia, appetite suppression, and mood changes. The fact that YY-162 did not ultimately reach the market raises questions as to whether this preclinical benefit was observed or consistently demonstrated in the Phase 3 human trials.

D. Target Indications

The primary target indication for Yuyu Pharma's YY-162 is Attention Deficit Disorder With Hyperactivity (ADHD) in children.[2] The term "Behavioural disorders" is also listed as an inactive indication in some databases.[2] The clinical trial program specifically enrolled children aged 6 to 12 years.[7]

E. Clinical Development Program

1. Overview of Key Clinical Trials

The clinical development of YY-162 for ADHD by Yuyu Pharma culminated in two key Phase 3 multicenter studies conducted in South Korea. These trials are consistently referenced in the available data:

• NCT01201187: This was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of YY-162 in children with ADHD over an 8-week treatment period. The trial commenced on March 1, 2010, and enrolled 144 participants.[2] It is listed as completed and was sponsored by Yuyu Pharma, Inc..[2]
• NCT01536210: This trial followed a similar design: a randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy and safety of YY-162 in children with ADHD, also over 8 weeks. It began on December 1, 2011 (or January 2012, according to one source [9]), and is also listed as completed and sponsored by Yuyu Pharma, Inc..[2] This trial is likely the "late Phase 3" or "confirmatory" study referred to in South Korean news reports from late 2011, which mentioned a revised dosage regimen.[5]

Table 2: Summary of Phase 3 Clinical Trials for YY-162 (ADHD - Yuyu Pharma, Inc.)

Feature	NCT01201187	NCT01536210
Trial ID	NCT01201187 2	NCT01536210 2
Phase	Phase 3 2	Phase 3 2
Status	Completed 2	Completed 2
Start Date	March 1, 2010 2	December 1, 2011 2 (or Jan 2012 9)
Sponsor	Yuyu Pharma, Inc. 2	Yuyu Pharma, Inc. 2
Number of Participants	144 7	Information on participant number not explicitly found for this trial in snippets, but likely similar to NCT01201187 given confirmatory nature.
Study Design	Randomized, Double-Blind, Placebo-control, Multicenter 2	Randomized, Double-Blind, Placebo-control, Multicenter 2
Duration	8 weeks 2	8 weeks 2
Key Objectives/Assessments	Evaluate clinical efficacy and safety. Assessments included: K-ARS, IOWA Conner's rating scale, CGI-S/I, ATA, Children's color trails test, Stroop test, Intelligence test (KEDI-WISC), adverse event reporting.7 (Applicable to both trials)	Evaluate clinical efficacy and safety. Assessments included: K-ARS, IOWA Conner's rating scale, CGI-S/I, ATA, Children's color trails test, Stroop test, Intelligence test (KEDI-WISC), adverse event reporting.7 (Applicable to both trials)
Primary Outcome Measures	Not explicitly detailed in snippets, but would relate to changes in ADHD symptom scores.	Not explicitly detailed in snippets, but would relate to changes in ADHD symptom scores.
Summary of Reported Results	Detailed efficacy and safety results are not publicly available in the provided materials.12 News from 2011 stated safety was secured in "early Phase 3".5	Detailed efficacy and safety results are not publicly available in the provided materials.14 News from 2011 anticipated positive outcomes for "late Phase 3".5

2. Design and Key Findings from Phase 3 Studies (Efficacy, Safety)

Both pivotal Phase 3 trials employed a robust design: randomized, double-blind, placebo-controlled, and multicenter, conducted over 8 weeks.2 The assessment battery was comprehensive, including validated ADHD rating scales (Korean ADHD Rating Scale (K-ARS), IOWA Conner's rating scale), global improvement scales (CGI-S/I), objective attention tests (Advanced Test of Attention (ATA)), neuropsychological tests (Children's color trails test, Stroop test), intelligence testing (KEDI-WISC), and systematic adverse event reporting.7

Despite the completion of these significant Phase 3 trials, specific, detailed efficacy and safety results are notably absent from the publicly accessible information provided. Attempts to access results via ClinicalTrials.gov were unsuccessful [12], and database entries often indicate that clinical results are behind a login or paywall.[2] This lack of transparent, detailed Phase 3 data is a major information gap, preventing a definitive assessment of YY-162's performance in human subjects.

However, South Korean news articles from November 2011, coinciding with the initiation of the later Phase 3 trial (NCT01536210), reported that YY-162 had "secured safety in the early Phase 3 clinical trial" (presumably NCT01201187) and was anticipated to demonstrate "equivalent or superior efficacy and safety" compared to methylphenidate.[5] The investigators involved in the late Phase 3 trial, including Professor Jo Su-cheol of Seoul National University Hospital, Professor Hong Hyun-joo of Hallym University Sacred Heart Hospital, and Professor Park Eun-jin of Inje University Ilsan Paik Hospital, are affiliated with major, reputable academic medical centers in South Korea, lending credibility to the conduct of these trials.[5]

3. Comparative Context with Standard ADHD Therapies

Preclinical data for YY-162 had suggested a profile comparable to methylphenidate in terms of efficacy but with potentially fewer behavioral side effects.2 The 2011 news reports explicitly positioned YY-162 as a potentially safer alternative to methylphenidate, citing parental concerns about side effects of stimulants, and also to atomoxetine, which carried warnings for children with certain heart conditions.5 The aim was to offer an effective natural product-based treatment that could mitigate these concerns.

F. Supporting Preclinical Research and Key Publications

The primary peer-reviewed publication detailing the preclinical pharmacology of Yuyu Pharma's YY-162 is: Lee, Jeong Hyun, et al. "YY162 prevents ADHD-like behavioral side effects and cytotoxicity induced by Aroclor1254 via interactive signaling between antioxidant potential, BDNF/TrkB, DAT and NET." Food and Chemical Toxicology, vol. 65, March 2014, pp. 280-292.[2] This study, with authors affiliated with Yuyu Pharma Inc. Research Center [3], provides the main body of evidence for the proposed mechanism of action and efficacy in animal models of ADHD.

Additionally, other research from Yuyu Pharma on YY-1224, identified as a terpene trilactone-strengthened Ginkgo biloba extract (a component of YY-162), demonstrated neuroprotective effects in preclinical models of Alzheimer's disease, partly via inhibition of cyclooxygenase-2 (COX-2).[16] While not directly related to ADHD, this indicates Yuyu Pharma's broader research interest in the neurological applications of Ginkgo biloba components.

G. Regulatory and Commercialization Trajectory

The highest development phase reported for YY-162 (ADHD) in some databases is "Pending Phase 3," with Phase 3 trials conducted in the United States and South Korea.[2] However, other sources clearly list both pivotal Phase 3 trials (NCT01201187, NCT01536210) as "Completed".[2] There are no records of YY-162 receiving marketing approval from the US FDA, Singapore's HSA, or other major regulatory agencies [11]; database entries typically show "First Approval Date -".[2]

Historically, in November 2011, Yuyu Pharma announced that it had received approval from the South Korean KFDA (now MFDS) to proceed with a late-phase 3 clinical trial for YY-162 with a modified dosage regimen.[5] At that time, the company expressed optimism, anticipating marketing approval in the first half of 2012 and a commercial launch in the first half of 2013.[5]

This anticipated timeline contrasts sharply with the current status. More than a decade after the projected launch, YY-162 for ADHD has not been marketed. Recent updates on Yuyu Pharma's R&D pipeline and strategy (from 2023-2024) do not mention YY-162 for ADHD.[17] Instead, the company's focus appears to have shifted towards the development of incrementally modified drugs (IMDs), such as new formulations of dutasteride for benign prostatic hyperplasia and hair loss, and exploring new ventures like pet care.[17] For instance, the development of YP-P10, a novel peptide for dry eye disease, was reportedly halted after Phase 2 clinical trials in the US.[20]

The discrepancy between the completion of two Phase 3 trials and the subsequent failure to achieve market launch, coupled with its absence from current pipeline discussions, strongly suggests that the YY-162 ADHD program was either discontinued or indefinitely shelved. The "Pending Phase 3" status in some databases might be an outdated entry or could imply that the completed Phase 3 trials were deemed insufficient for a regulatory filing, perhaps requiring additional studies that were not pursued.

Yuyu Pharma's strategic revision in 2024 to concentrate on "개량신약" (incrementally modified drugs/improved versions of existing drugs) rather than prioritizing entirely novel drug candidates like YY-162 for ADHD or the dry eye peptide YP-P10, points towards a more conservative R&D approach.[20] This strategic shift could be influenced by various factors, including the substantial financial investment and high risks associated with novel drug development (as one source notes, even IMDs can require significant R&D expenditure and Phase 3 trials with uncertain returns [21]), potentially disappointing results from past novel candidates, or a business decision to leverage existing market familiarity with established molecules. This broader strategic context makes the apparent discontinuation of the YY-162 ADHD program more understandable, even if the Phase 3 trials were fully executed. The company may have concluded that the overall risk-reward profile for YY-162 was no longer favorable in light of the trial outcomes or evolving market conditions.

IV. Synthesis and Concluding Remarks

A. Recapitulation of the Distinct Characteristics

This report has detailed the available information concerning two distinct investigational agents that share the designation "YY-162." The first is a tyrosine kinase inhibitor under development by an unspecified consortium for oncological indications, currently in early Phase 1 clinical trials. The second is a combination of Ginkgo biloba and Ginseng extracts developed by Yuyu Pharma, Inc., for ADHD in children, which completed Phase 3 clinical trials over a decade ago. Their fundamental differences in origin, chemical nature, mechanism of action, therapeutic targets, and developmental trajectory have been elucidated.

B. Key Considerations and Unanswered Questions

Several critical questions and information gaps remain for both entities:

• For the oncology YY-162 (Tyrosine Kinase Inhibitor):
• The identity of the specific institutions and companies forming the development consortium is unknown, making it difficult to track its lineage and future plans.
• Quantitative preclinical data (e.g., kinase inhibition profiles, in vivo efficacy) and detailed Phase 1 results (e.g., MTD, RP2D, specific adverse event profiles, objective response rates by tumor type) are needed for a thorough assessment of its potential.
• Clarity on the precise tyrosine kinase(s) targeted by this agent is essential to understand its specificity and rationale across diverse cancer types like HER2-positive breast cancer, EGFR-mutant NSCLC, and KRAS-mutant colorectal cancer.
• Its future prospects hinge on the generation of robust Phase 2 efficacy and safety data.
• For the ADHD YY-162 (Yuyu Pharma's Ginkgo-Ginseng Combination):
• The most significant unanswered question is why this product was not brought to market despite Yuyu Pharma completing two Phase 3 clinical trials and expressing considerable optimism for a launch in 2013.
• The lack of publicly available, detailed results from the pivotal Phase 3 trials (NCT01201187 and NCT01536210) is a critical information void. Access to these results would clarify whether the program was halted due to insufficient efficacy, unexpected safety concerns, or strategic/commercial considerations.
• Understanding the final clinical outcomes is crucial to assess the translatability of its promising preclinical profile, particularly the claim of comparable efficacy to methylphenidate with negligible side effects.

C. Importance of Precise Nomenclature and Data Curation

The existence of two unrelated drug candidates sharing the same "YY-162" identifier underscores the challenges that can arise from ambiguous drug nomenclature in research, development, and information management. Such ambiguities can lead to misattribution of data, confusion in scientific literature, and inefficiencies in tracking developmental progress. This situation highlights the critical need for clear, unique identifiers for investigational compounds and meticulous data curation in both public and proprietary drug databases to ensure accuracy and prevent misinterpretations.

D. Overall Conclusion

Based on the available information, the two entities designated YY-162 are at vastly different stages and have distinct prospects. The oncological YY-162 is an early-stage tyrosine kinase inhibitor whose potential remains to be defined by more substantive clinical data and greater transparency regarding its development. The ADHD YY-162 developed by Yuyu Pharma, despite advancing through late-stage clinical trials with initial positive expectations, appears to be a discontinued program. This latter case serves as a salient reminder of the high attrition rates inherent in pharmaceutical R&D, where even compounds reaching Phase 3 may not ultimately achieve regulatory approval or commercialization for a multitude of scientific, clinical, regulatory, or strategic reasons. Further disclosure of the Phase 3 trial results for Yuyu Pharma's YY-162 would be valuable for the scientific community to understand its clinical performance and the reasons for its apparent developmental cessation.

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