Pipelines

KIYAN PHARMA Fukuroi Plant

Our Pipeline at a Glance

Our “pipeline” refers to a list of drug candidates currently under research and development. This list encompasses projects from the initial exploration phase through clinical trials, up to the stages just before entering the market. Through our pipeline, we provide transparency to investors and patients about the areas of disease we are focusing on and the progress in developing innovative treatments.

Basic Research

New Diabetes Cure Drug (Cell Targeting Technology)

Using a Biozipcode for diabetes stem cells to target existing HDAC inhibitors to these cells. Cell-Targeted Drugs: The ultimate new technology beyond molecular targeting.

Basic Research

Tissue Regeneration (Cell Targeting Technology)

Development of tissue regeneration materials that can integrate into tissues without the need for transplantation or sutures. This is a new regenerative therapy focused on healing skin damage, such as burns.

Basic Research

Non-clinical (Animal) Studies

Diabetes Diagnostic Drug

Selling companion diagnostics that determine diabetes based on the presence of diabetes stem cells in peripheral blood.

Non-clinica Study POC

Cancer Drug with No Side Effects (Cell Targeting Technology)

By utilizing a common Biozipcode for cancer, not only new drugs but also previously unusable drugs due to side effects can be reused.

Non-clinica Study POC

Diabetes Cure Drug (Reposisioning)

Treatment method using the existing HDAC inhibitor ” HDAC inhibitor” + “Insulin.” By repositioning existing drugs, it is applied to patients with type 2 diabetes.

Non-clinica Study POC (Done)

Phase I: Safety and Dosage

Phase II: Efficacy and Side Effects

Phase III: Confirmatory Trials

About Each Pipeline Stage

Basic Research

Basic research lays the foundation of drug discovery, where scientists explore the biological and chemical mysteries of diseases at a molecular level. This phase is pivotal for identifying potential targets for new drugs and understanding the pathophysiology of diseases. Through innovative research, we uncover the building blocks for future therapies.

Key Points:

Identifies and validates potential drug targets.
Utilizes advanced technologies for understanding disease mechanisms.
Involves extensive literature reviews, computational modeling, and laboratory experiments.
Focuses on understanding the interaction between biological systems and potential therapeutic compounds.
Essential for generating hypotheses about how new drugs might affect disease processes.

Non-clinical (Animal) Studies

Non-clinical studies, often referred to as preclinical tests, involve rigorous testing of drug candidates in animal models before proceeding to human trials. These studies are critical for assessing the safety profile, pharmacokinetics, pharmacodynamics, and potential efficacy of the compound. This phase ensures that only the most promising drug candidates with a favorable safety margin proceed to clinical trials.

Key Points:

Evaluates the toxicity, metabolism, and pharmacological effects of the compound in animal models.
Determines the safe dosage range and identifies potential side effects.
Assesses the compound’s effect on various biological systems and its mechanism of action.
Provides crucial data for designing human clinical trials, including dosing regimens.
Regulatory authorities require comprehensive non-clinical study data before approving the progression to human clinical trials.

Phase I: Safety and Dosage

Phase I trials mark the initial introduction of the investigational drug into humans. These studies are primarily concerned with assessing the drug’s safety, tolerability, pharmacokinetics, and pharmacodynamics. The goal is to find the optimal dose that can be administered safely without causing severe side effects.

Key Points:

Focus on evaluating drug safety and determining the appropriate dosage.
Involves a small group of 20-100 healthy volunteers or patients.
Assesses how the drug is absorbed, metabolized, and excreted in humans.
Identifies side effects associated with increasing doses.

Phase II: Efficacy and Side Effects

Phase II trials further evaluate the drug’s effectiveness for a particular condition or disease within a larger group of participants (100-300). These studies continue to monitor safety, including short-term side effects, while starting to gather preliminary data on how well the drug works to treat or prevent a health condition.

Key Points:

Focus on the drug’s effectiveness and further assessment of safety.
Involves several hundred participants who have the condition or disease.
Helps to determine the optimal dose for efficacy while minimizing side effects.
Provides additional safety data and initial efficacy of the drug.

Phase III: Confirmatory Trials

In Phase III trials, the drug is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely. These trials are pivotal for regulatory approval.

Key Points:

Aimed at confirming the drug’s effectiveness on a larger scale and assessing its overall risk-benefit ratio.
Involves large groups of patients.
Compares the new drug to standard-of-care treatments.
Critical for obtaining regulatory approval from authorities like the FDA.

Phase IV: Post-Marketing Surveillance

After a drug has been launched on the market, Phase IV trials are conducted to gather more information about the drug’s effect in various populations and any side effects associated with long-term use. These studies may also explore the drug’s potential for other conditions and further refine its usage guidelines.

Key Points: