CKD-385: An Investigative Report on its Profile, Clinical Development, and Current Status

1. Executive Summary

CKD-385 is identified as a small molecule drug developed by Chong Kun Dang Pharmaceutical Corp..[1] Its primary therapeutic focus has been cardiovascular diseases, with investigations into angina pectoris, heart failure, and hypertension.[1] The clinical development program for CKD-385 involved a series of Phase 1 trials initiated in South Korea around 2020-2021. These studies were designed to evaluate the pharmacokinetic (PK) properties and safety of CKD-385, including high-dose formulations, in healthy volunteers under both fed and fasting conditions.[1] Older information also suggests a potential, likely discontinued, Phase 2 study for hypertension in the United States.[1]

Despite this early-phase clinical activity, a significant uncertainty surrounds CKD-385's current development trajectory. The compound is notably absent from Chong Kun Dang Pharmaceutical Corp.'s recent official R&D pipeline disclosures.[4] This omission, coupled with reports from pharmaceutical databases indicating an "Unknown status" for its clinical trials or "No recent reports of development" as of early 2024 [1], strongly suggests that the development of CKD-385 may have been deprioritized, paused, or discontinued. Furthermore, critical details such as its specific molecular target, a comprehensive mechanism of action, definitive chemical structure (including CAS Number), and any published results from its clinical trials are largely unavailable in the public domain based on the provided information.

2. CKD-385: Profile and Developer

2.1. Chemical Nature and Identification

CKD-385 is characterized as a small molecule drug.[1] This classification implies it is a chemically synthesized compound, likely possessing a relatively low molecular weight, suitable for oral or other forms of systemic administration. The designation "CKD-385" is consistent with an internal development code utilized by Chong Kun Dang Pharmaceutical Corp. (CKD). An International Nonproprietary Name (INN), common chemical name, or specific brand name for CKD-385 has not been identified in the available research materials.

A specific CAS (Chemical Abstracts Service) Registry Number for the CKD-385 entity itself is not provided in the accessible documentation.[1] It is important to note that references to "TR-385" (Methyl Bromide, CASRN 74-83-9) [5] and components of "Amercoat 385 Hardener" [6] are unrelated to the pharmaceutical compound CKD-385 and should be disregarded in this context. The absence of a unique CAS number for CKD-385 in multiple drug databases is common for early-stage investigational compounds but complicates independent tracking, making reliance on the development code paramount.

Detailed information concerning the precise chemical structure, molecular formula, and molecular weight of CKD-385 is not available within the provided research documentation.[1] This lack of fundamental chemical identification in publicly accessible records for a compound that has reportedly entered Phase 1 clinical trials is noteworthy. Typically, as a compound progresses through development, especially into human testing, more detailed chemical information becomes available through patent filings, scientific publications, or regulatory disclosures. The continued absence of such data for CKD-385 may suggest that its development was halted before broader dissemination of this information occurred, or that such details are being kept strictly proprietary. For entities considering investment or collaboration, this opacity regarding the basic chemical nature of the compound presents a significant challenge for due diligence and independent assessment.

2.2. Developer: Chong Kun Dang Pharmaceutical Corp.

CKD-385 was originated and its development has been pursued by Chong Kun Dang Pharmaceutical Corp. (CKD).[1] CKD is a major South Korean pharmaceutical company with a long operational history, founded in 1941, and has established capabilities in research, development, manufacturing, and commercialization of pharmaceutical products.[8] The company's R&D activities span New Chemical Entities (NCEs), Incrementally Modified Drugs (IMDs), and Biologics, covering therapeutic areas such as oncology, metabolic diseases, immunology, and cardiovascular diseases.[9] Chong Kun Dang's pipeline has included other cardiovascular agents, for example, CKD-508 for dyslipidemia and CKD-828 for hypertension, indicating an ongoing strategic interest in this therapeutic field.[4]

2.3. Classification

Pharmacologically, AdisInsight categorizes CKD-385 under several therapeutic classes related to cardiovascular health: Antihyperlipidemics, Antihypertensives, Cardiovascular therapies, Heart failure therapies, and Ischaemic heart disorder therapies.[2] This broad classification aligns with the range of indications for which CKD-385 has reportedly been investigated. Furthermore, CKD-385 is designated as a New Molecular Entity (NME) [2], confirming that it is an original compound and not a modification or derivative of an existing approved drug.

The wide therapeutic classification reflects the intended clinical applications of CKD-385. However, in the absence of a defined mechanism of action or a known molecular target from the provided data, a more precise pharmacological classification (e.g., beta-blocker, ACE inhibitor, calcium channel blocker) cannot be established. This lack of mechanistic detail is a critical missing component for fully understanding the drug's novelty, its potential advantages over existing therapies, and its specific role within the cardiovascular treatment landscape.

3. Therapeutic Rationale and Investigated Indications

3.1. Primary Focus: Cardiovascular Diseases

The development program for CKD-385 has been predominantly centered on cardiovascular diseases, with several specific conditions targeted:

• Angina Pectoris: This indication is listed by Synapse as an active area of investigation, with the highest development phase reported as "Preclinical" in South Korea.[1] In contrast, AdisInsight, in an update from February 2024, stated "No development reported" for Phase 1 development of CKD-385 for angina pectoris (oral tablet formulation) in South Korea.[2] This discrepancy suggests either a very early stage of investigation that did not progress or differing update cycles between databases.
• Heart Failure: Similar to angina pectoris, Synapse indicates a "Preclinical" highest development phase in South Korea.[1] AdisInsight (February 2024) also reports "No development reported" for Phase 1 development for heart failure (oral formulation) in South Korea.[2]
• Hypertension: Information regarding hypertension is particularly inconsistent. Synapse lists hypertension as an "inactive indication" yet simultaneously notes "Phase 2" in the United States as its highest achieved development phase.[1] This is a significant point of divergence, as AdisInsight (February 2024) shows "No development reported" for hypertension more broadly.[2] Supporting the notion of some earlier activity, GlobalData's catalyst calendar mentioned Phase 1 trial completion for "Cardiovascular Disease" and "Unspecified Cardiovascular Disorders" by October 2019, which could have encompassed hypertension studies.[11] The "inactive" status suggests any such Phase 2 US program was likely concluded or halted.
• General Cardiovascular Disorders/Healthy Volunteer PK Studies: More recent clinical activity, specifically several Phase 1 trials initiated between 2020 and 2021 in South Korea, were conducted under the broader condition of "Cardiovascular Diseases." These studies, however, were performed in healthy volunteers and were primarily designed to assess pharmacokinetic profiles and safety, rather than efficacy in a specific disease state.[3]

3.2. Mechanism of Action (MoA)

A critical gap in the available information is the precise molecular target and mechanism of action for CKD-385. Across multiple database entries, the MoA is listed as "Undefined" or is not specified.[1] General pharmacological discussions within the provided materials pertain to other cardiovascular drugs or broader concepts of chronic kidney disease management and do not offer specific insights into how CKD-385 exerts its effects.[14]

The absence of a disclosed MoA for a drug candidate that has progressed into Phase 1 clinical trials is unusual. Typically, a hypothesized MoA and evidence of target engagement are established during preclinical research to justify human testing. This lack of clarity for CKD-385 significantly hinders an assessment of its scientific rationale, its novelty compared to existing cardiovascular treatments, and its potential for differentiated therapeutic benefit. It may imply that the compound was developed through phenotypic screening where the exact molecular target was initially unknown, the mechanism is novel and highly proprietary, or that initial hypotheses about its MoA were not substantiated during early investigations. Given the apparent cessation of development, the latter possibilities, or an inability to demonstrate clear pharmacodynamic effects related to a specific target, are plausible contributing factors.

3.3. Discrepancies and Evolution of Reported Development

The conflicting reports regarding CKD-385's development stages highlight potential shifts or discontinuations in its program. The mention of a "Phase 2" study for hypertension in the United States [1] appears to be historical, likely predating the 2020-2021 cluster of Phase 1 trials in South Korea. The "inactive indication" status for hypertension from the same data source supports the notion that this earlier US-based effort was probably discontinued.

The "Preclinical" status for angina and heart failure in South Korea [1], despite the subsequent initiation of Phase 1 PK studies, suggests these indications might have been the intended therapeutic targets following successful completion of the initial human safety and PK assessments. However, the AdisInsight report of "No development reported" for these Phase 1 programs as of February 2024 [2] strongly indicates that these efforts did not advance beyond the initial stages or were formally halted.

4. Clinical Development Program

4.1. Phase 1 Clinical Trials in Healthy Volunteers (South Korea)

Between 2020 and 2021, Chong Kun Dang Pharmaceutical Corp. initiated a series of Phase 1 clinical trials in South Korea. These studies were primarily designed to evaluate the pharmacokinetic (PK) profiles, safety, and tolerability of CKD-385, including various doses and the effect of food, in healthy adult volunteers. These trials represent the most recent and well-documented clinical activity for CKD-385 found in the provided information.

Table 1: Summary of Registered Phase 1 Clinical Trials for CKD-385 in South Korea (2020-2021)

NCT Identifier	Official Title (Abbreviated)	Status (Latest Reported)	Sponsor	Condition(s) Investigated	Key Objectives	Target Enrollment	Location(s)	Reference Drug (if mentioned)	Key Snippet(s)
NCT04906785	PK Profiles and Safety of CKD-385 High-dose in Healthy Volunteers Under Fed Conditions	Unknown	Chong Kun Dang Pharmaceutical	PK/Safety in Healthy Volunteers - Fed, High-Dose	Evaluate PK profiles and safety	52	National University Hospital, Jeonju, South Korea	D744	1
NCT04906798	PK Profiles and Safety of CKD-385 High-dose in Healthy Volunteers Under Fasting Conditions	Unknown	Chong Kun Dang Pharmaceutical	PK/Safety in Healthy Volunteers - Fasting, High-Dose	Evaluate PK profiles and safety	52	Chonbuk National University Hospital, Jeonju, South Korea	D744	1
NCT04678388	PK Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fasting Conditions	Unknown	Chong Kun Dang Pharmaceutical	PK/Safety in Healthy Volunteers - Fasting, High-Dose	Investigate PK profiles and safety	Not Specified	South Korea	Not Specified	1
NCT04651881	PK Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions	Unknown	Chong Kun Dang Pharmaceutical	PK/Safety in Healthy Volunteers - Fed, High-Dose	Investigate PK profiles and safety	24	Central Hospital, Gyeonggi-do, Siheung-si, South Korea	Reference drug, Test drug 1, Test drug 2	12

Common Objectives & Design Elements:

The primary objectives across these Phase 1 trials were consistent: to evaluate standard pharmacokinetic parameters such as Area Under the Curve (AUCt, AUCinf), maximum concentration (Cmax), time to maximum concentration (Tmax), elimination half-life (T1/2), apparent clearance (CL/F), and apparent volume of distribution (Vd/F).12 Safety and tolerability were also key endpoints. The trials employed randomized, open-label, single-dose, crossover designs. Notably, several trials specified the investigation of "high-dose" CKD-385 and assessed its PK under both fasting and fed conditions to understand food effects.3

Reference Drug D744 / Other Test Drugs:

In trials NCT04906785 and NCT04906798, a drug referred to as "D744" was listed as a comparator or reference.3 Trial NCT04651881 mentioned a "Reference drug" and "Test drug 1" and "Test drug 2," likely referring to different doses or formulations of CKD-385 itself.12 The specific identity and purpose of D744 are not elucidated in the provided information, representing a gap in understanding the full context of these studies.

Timelines & Current Status:

These Phase 1 trials were registered or had their information posted primarily between 2020 and 2021.3 However, more recent updates from pharmaceutical databases in 2024 consistently report their status as "Unknown" 1 or note "No recent reports of development" for CKD-385's Phase 1 activities in cardiovascular disorders in South Korea.2 No published peer-reviewed articles or conference presentations detailing the results or outcomes of these specific clinical trials were identified within the provided research materials.12

The initiation of at least four similar Phase 1 PK studies in healthy volunteers over a concentrated period (2020-2021) indicates a significant early-stage commitment by Chong Kun Dang to thoroughly characterize CKD-385's basic human pharmacology. The focus on "high-dose" formulations and food effects is standard practice to define the dosing parameters and administration guidelines for subsequent patient trials. The subsequent lack of publicly available results and the progression to Phase 2 trials for the intended cardiovascular indications (angina, heart failure) in South Korea, where these foundational studies were conducted, is a strong indicator that the findings may not have supported continued development as originally envisioned. Such a silence often implies that the drug candidate did not meet predefined criteria for safety, tolerability, or pharmacokinetic profile necessary to advance.

4.2. Earlier Reported Development (Pre-2020)

There are indications of an earlier phase of development for CKD-385 that predates the 2020-2021 South Korean Phase 1 studies:

• GlobalData's catalyst calendar noted a "Phase I Trial Completion" for CKD-385 in the context of "Cardiovascular Disease" and "Unspecified Cardiovascular Disorders" as of October 1, 2019.[11] This suggests that at least one Phase 1 study had concluded prior to the initiation of the later series of trials.
• Synapse data indicate a "Phase 2" highest development stage for CKD-385 in "Hypertension" specifically within the "United States".[1] However, the same source also lists hypertension as an "inactive indication," implying this Phase 2 effort is no longer ongoing.

This earlier development activity, particularly the mention of a Phase 2 trial in the US for hypertension, seems distinct from the 2020-2021 South Korean Phase 1 program, which focused on broader cardiovascular PK/safety in healthy volunteers. It is plausible that the earlier US-based hypertension program was discontinued or yielded results that prompted a re-evaluation of the compound, potentially leading to the subsequent Phase 1 studies in South Korea with different objectives, formulations, or target indications. The lack of any recent updates or corroborating information regarding an active US Phase 2 trial for CKD-385 makes its current relevance highly questionable and supports the "inactive indication" status.

5. Current Development Status and Future Outlook

5.1. Analysis of Conflicting and Stagnant Information

The publicly available information regarding CKD-385's development status is characterized by inconsistencies and a lack of recent updates. While Synapse indicates a "Preclinical" status for angina and heart failure in South Korea, it also lists the 2020-2021 Phase 1 trials for PK/safety in the same region.[1] This suggests the preclinical designation might refer to the disease-specific efficacy studies that would typically follow foundational Phase 1 work.

More critically, AdisInsight's report from February 2024 stating "No development reported" for Phase 1 activities in South Korea related to angina, heart failure, and general cardiovascular disorders [2] directly contradicts the earlier registration and initiation of these trials unless it implies a definitive halt after initiation, without progression or public disclosure of outcomes. The earlier US Phase 2 mention for hypertension [1] is likely a historical artifact of a discontinued program, given the more recent preclinical/Phase 1 focus in Korea for other cardiovascular applications and its "inactive" status.

5.2. Conspicuous Absence from Chong Kun Dang's Official Pipeline

The most significant indicator of CKD-385's current standing is its absence from Chong Kun Dang Pharmaceutical Corp.'s official R&D pipeline, as presented on their corporate website.[4] The company's disclosed pipeline details numerous other investigational compounds, including several designated with "CKD-" prefixes, across various therapeutic areas and stages of development. Notably, this includes other cardiovascular candidates such as CKD-508 (for dyslipidemia, listed as Phase 1) and CKD-828 (an IMD for hypertension, listed as Phase 3).[4]

Pharmaceutical companies typically use their official pipeline disclosures to highlight ongoing and strategically important R&D projects to the investment community and the public. The omission of CKD-385, a compound that has undergone multiple registered Phase 1 clinical trials, from these current listings is a strong implicit statement about its present status. This, combined with the "no recent reports of development" from independent pharmaceutical intelligence databases [2], strongly suggests that CKD-385 is not an actively progressing asset within Chong Kun Dang's portfolio. Review of company financial reports or investor presentations available in the snippets also did not yield mentions of CKD-385, further corroborating this assessment.[10]

5.3. Regulatory Status and Publications

No information within the provided research snippets indicates any regulatory approvals (e.g., from the FDA, EMA, or South Korea's MFDS for marketing) or any special regulatory designations (such as Fast Track, Orphan Drug, or Breakthrough Therapy) for CKD-385. General regulatory documents cited [32] are not specific to CKD-385.

Furthermore, there is a notable absence of peer-reviewed publications or conference presentations detailing the preclinical pharmacology, specific mechanism of action, or the results from any of the Phase 1 clinical trials conducted for CKD-385.[12] Searches of Korean medical society proceedings also did not yield specific results for CKD-385 within the provided materials.[34] This lack of data dissemination is common for compounds that do not successfully transition to later stages of development.

5.4. Potential Future Outlook and Implications

Considering the collective evidence, the future prospects for CKD-385 appear highly uncertain, with a strong probability of development having been discontinued. The intensive Phase 1 program, which included "high-dose" studies, may have encountered challenges related to an inadequate pharmacokinetic profile, safety or tolerability concerns at potentially therapeutic exposures, or a lack of clear pharmacodynamic signals if such were assessed in healthy volunteers.

Alternatively, strategic shifts within Chong Kun Dang's broader R&D portfolio could have led to the deprioritization of CKD-385 in favor of other candidates perceived to have a higher probability of success or greater commercial potential. For instance, their pipeline includes CKD-510, an HDAC6 inhibitor with applications in cardiovascular and rare diseases, which was licensed out to Novartis in a significant deal, indicating a strategic focus on other assets.[10]

In the pharmaceutical industry, the absence of positive news or updates following early-stage clinical trials, especially when a compound is no longer featured in official company communications, often signifies that a program has been halted. The resources invested in multiple Phase 1 studies suggest initial promise for CKD-385, but the subsequent silence and removal from active pipeline listings point towards significant hurdles that likely prevented its progression.

6. Conclusion and Key Considerations

CKD-385, a small molecule drug developed by Chong Kun Dang Pharmaceutical Corp., was investigated for cardiovascular indications, including angina pectoris, heart failure, and hypertension. Its most recent documented clinical development involved a series of Phase 1 pharmacokinetic and safety studies in healthy volunteers conducted in South Korea between 2020 and 2021. There is also historical, less substantiated, information suggesting an earlier, and likely discontinued, Phase 2 effort for hypertension in the United States.

The current development status of CKD-385 is best characterized as likely inactive or discontinued. This assessment is based on its conspicuous absence from Chong Kun Dang's current official R&D pipeline disclosures and consistent "no recent development reported" or "unknown status" flags from multiple third-party pharmaceutical intelligence databases for its clinical trials.

Several critical information gaps persist regarding CKD-385:

• Molecular Target and Mechanism of Action: These fundamental aspects of the drug's pharmacology remain undefined in the public domain.
• Chemical Identity: No specific CAS number, detailed chemical structure, or verified molecular formula for CKD-385 is available through the provided research materials.
• Clinical Trial Outcomes: There are no publicly available peer-reviewed publications or conference presentations detailing the results from the Phase 1 clinical trials (NCT04906785, NCT04906798, NCT04678388, NCT04651881) or any earlier studies.
• Reference Drug D744: The identity and rationale for the use of "D744" as a comparator in some Phase 1 trials are unknown.
• Reason for Discontinuation/Deprioritization: The specific reasons (e.g., suboptimal efficacy, safety concerns, strategic reallocation of resources) for the apparent cessation of active development have not been publicly disclosed by Chong Kun Dang.

In conclusion, while CKD-385 progressed to early-stage human clinical trials, the available evidence strongly suggests that its development journey has been halted or significantly altered. The lack of transparency regarding its fundamental pharmacological properties and clinical findings, combined with its disappearance from the developer's public R&D focus, makes any positive future outlook highly speculative. Without new disclosures or data from Chong Kun Dang Pharmaceutical Corp., CKD-385 stands as an example of an early-stage drug candidate that, based on current information, did not successfully transition to later stages of clinical development.

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