Development of a Cure for Diabetes and its Complications

Development of a Cure for Diabetes and its Complications2024-02-03T16:50:37+09:00


This project aims to develop a method to completely cure diabetes. Current treatments focus on balancing blood sugar levels, but they do not completely cure diabetes itself. Furthermore, there are problems with diabetes and its complications being difficult to treat once they occur.

To solve this issue, we are focusing on the specific cells that are the root cause of diabetes. First, we will create a new diagnostic agent to find these cells. Then, we plan to work on the development of a new drug to completely cure diabetes. Our goal is to find a true cure for diabetes.


Point 1: There are 537 million people living with diabetes in the world

One in ten adults has diabetes. One in five elderly people have diabetes.

Diabetes accounts for more than 10% of the world’s total medical expenses, costing nearly 135 trillion yen, putting pressure on the global medical economy.

Point 2: Currently, diabetes is a disease that cannot be cured once it develops.

Currently, even specialists are not saying that it can be cured. Diabetes is generally recognized as a disease that cannot be cured once it develops.

Diabetes treatment is a coping therapy called blood sugar control, and there is still no “cure drug” yet.

Point 3: However, our research found that diabetes can be completely cured.

Oral administration of insulin and HDAC inhibitors*
*Alternatively, complete cure has been demonstrated in experiments on mice by intravenous injection.

Actually, the pancreas is not the direct cause, but an abnormality in hematopoietic stem cells in the bone marrow.

Therefore, it may be possible to completely cure diabetes with oral medication.

[Point 1: Diabetic population in the world]

– There are 537 million people living with diabetes in the world –

International Diabetes FederationのIDF Diabetes Atlasより
International Diabetes Federation from IDF Diabetes Atlas
International Diabetes FederationのIDF Diabetes Atlasより
International Diabetes Federation from IDF Diabetes Atlas

Diabetes is a global problem. More than 1 in 10 adults worldwide have diabetes, and in some countries, 1 in 5 people are diabetic.

Looking at the numbers specifically, in 2000, among adults aged 20 to 79, 151 million people (4.6% of the global population) had diabetes. However, this number has now increased to more than three times, reaching 537 million (10.5%).

If the increase continues at this rate, it is estimated that 643 million people (11.3%) will have diabetes by 2030, and 783 million (12.2%) by 2045.

The number of people with diabetes is rapidly increasing and is likely to continue to rise, making it a highly concerning disease.

[Point 2: Drugs that completely cure diabetes]

– Currently, diabetes is a disease that cannot be cured once it develops –

The development of a cure for diabetes is a significant advancement that brings new hope to this disease, which currently has limited treatment options. Diabetes is considered difficult to cure with current medical knowledge once it has developed. Patients must continuously manage their blood sugar levels and face the risk of complications throughout their lives. However, if the development of a cure is successful, it could fundamentally solve these challenges and dramatically improve the quality of life for patients.

We are engaged in the research and development of this groundbreaking treatment. By providing a cure for diabetes to the market, we contribute to the improvement of patient health and well-being, as well as to the reduction of medical costs and the alleviation of socio-economic burdens. Diabetes is a global health issue, and solving it benefits society as a whole.

Our mission is to provide innovative solutions to the longstanding medical challenge of diabetes. To achieve this goal, we are pursuing cutting-edge research and approaches based on the needs of patients. We continue to work tirelessly to bring new hope to diabetes patients.

[Point 3] Papers and research results

– Our research shows that diabetes can be completely cured –

グラフ 糖尿病にしたマウスに対して、9週間薬を投与し続けた結果 紫と赤色の値は、薬の投与を辞めても血糖値は下がっている
As a result of continuing to administer drugs to diabetic mice for 9 weeks, the purple and red values indicate that blood sugar levels continued to fall even after drug administration was stopped.
図 造血幹細胞の分化の様子
Differentiation of hematopoietic stem cells
図 組織再生時に働く造血幹細胞由来システムの糖尿病における異常
Abnormalities in the hematopoietic stem cell-derived system that functions during tissue regeneration in diabetes

Our research has shown that diabetes can be completely cured, and that diabetes and its complications can be completely cured (remitted) through treatment. In addition, all of this has been proven in a paper, and the results have been accepted.

It has been discovered that hematopoietic stem cells in the bone marrow, which differentiate into blood components, become abnormal due to high blood sugar, and this abnormality, either persisting or being remembered by the cells, is the cause. It is now possible to return to normal (i.e., to cure) by eliminating these cells with medication.

The answer to the question, ‘Why do drugs (HDAC inhibitors) work?’ is also the answer to the question, ‘Why wasn’t diabetes curable before?’

Due to high blood sugar, hematopoietic stem cells exhibit abnormal expression of HDAC, and these cells migrate to various organs, destroying cell and tissue functions. Therefore, as a solution, treatment involves directly applying medication to eliminate these abnormal hematopoietic stem cells.

Business Development

図 膵臓の写真 左が健康なマウスで、右が糖尿病のマウス。異常な造血幹細胞が写る
Photos of the pancreas: A healthy mouse on the left, a diabetic mouse on the right. Photograph of abnormal hematopoietic stem cells
図 未治療STZ糖尿病マウスの肝臓に出現したインスリン陽性細胞(上段)と遺伝子治療による肝臓に出現した膵島(下段)の比較
Comparison of insulin-positive cells that appeared in the liver of untreated STZ diabetic mice (upper row) and pancreatic islets that appeared in the liver after gene therapy (lower row)
図 薬剤(HDAC阻害剤)によって起きたそれぞれの発現量の変化
Changes in each expression level caused by drugs (HDAC inhibitors)

Strategies for diabetes cure and therapeutic drugs

As HDAC inhibitors are already on the market for other therapeutic effects (meaning they are already commercially available), their safety as a drug is assured. Therefore, the development cost and duration will not be as extensive as for a new drug, and we will conduct clinical development for the ‘diabetic treatment effect’ which is a different use from the original purpose of the drug. Through clinical trials, we will evaluate and verify efficacy and safety, apply for approval to the authorities, and finally aim to obtain manufacturing and marketing approval as a pharmaceutical product from the country.

Since this drug is also effective against diabetes complications (such as nephropathy, retinopathy, and neuropathy), we will conduct clinical development for these as well. Meanwhile, we will develop a new drug superior to existing HDAC inhibitors while advancing the above project.

Our goal is to start Phase I trials in 2024 and enter Phase III trials in 2025. Furthermore, as the approval process for veterinary medicines for animal pets differs from human clinical trials, it can be approved more quickly, and we aim to bring it to market sooner.

In Japan, we aim to confirm the pharmacological effects in Phase IIa trials of clinical trials on our own. In addition, we plan to conduct clinical trials abroad in collaboration with overseas companies. Our company, by capturing 1% of the global market share in diabetes treatment, anticipates annual sales of around 1 trillion yen, so instead of aiming for a listing, we are looking to expedite the sale of the drug through partnerships with pharmaceutical companies and others.

Development of new diagnostic agents for diabetes

We are developing a new diagnostic drug that identifies the abnormal stem cells causing the incurability of diabetes. This will enable a clear-cut decision, replacing traditional measures such as fasting blood sugar levels and Hemoglobin A1C (HbA1C) values. The introduction of a new diabetes diagnostic drug into the market would represent a significant advancement in the medical industry, creating various impacts.

However, the introduction of this new diagnostic drug, while leading to improved diagnostic accuracy, may also necessitate changes in the current insurance system and regulatory environment. Therefore, we aim for a phased introduction and adoption, initially focusing solely on the indicators of remission in patients already diagnosed with diabetes.

Development of drugs for treating diabetes and its complications for pets

The pet-related market is predicted to be around 13 trillion yen, suggesting a considerable market size for pharmaceuticals for pets. The market for pet pharmaceuticals is also estimated to be in the trillions of yen. (Often, pharmaceuticals designed for humans are used for pets, but there are companies that solely focus on pharmaceuticals targeted at pets.)

Unlike human medications, pharmaceuticals for pets do not require a process of several years of clinical trials and can be approved solely by the Ministry of Agriculture, Forestry, and Fisheries.



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Will the new drug be administered orally or via intravenous injection?2024-01-21T19:59:30+09:00

Both methods are currently considered feasible for development.

Is the new drug effective for Type 1 diabetes?2024-01-22T01:05:48+09:00

The drug is intended for all patients with diabetes, regardless of the severity or type (Type 1 or Type 2), and is also expected to be effective for almost all complications of diabetes. Please refer to the drug’s mechanism of action for more details.

What are the development costs and funding plans for the new drug?2024-01-21T19:49:58+09:00

The development cost for the new drug typically requires several ten of million to hundreds of USD. Our company is considering raising funds through investors, government and private grants, and joint research partnerships to secure the necessary funds for research and development, clinical trials, and regulatory applications. Efficient fundraising and resource optimization are essential for the success of new drug development.

Is there a plan to launch the new drug in the international market?2024-01-21T19:47:58+09:00

The expansion into international markets will be considered based on the regulations and market demands of each country. Diabetes is a global health issue, so there is an anticipated international demand.

How is the target patient group for the new drug determined?2024-01-21T19:47:34+09:00

The target patient group is determined based on the results of clinical trials. Particularly, patients with severe diabetes or those who have not improved with other treatments may be prioritized.

What are the main challenges in the development of the new drug?2024-01-21T19:47:00+09:00

The primary challenge in developing the new drug is finding an effective treatment that addresses the fundamental cause of diabetes. Current treatments mainly focus on managing blood sugar levels and do not lead to a complete cure of the disease itself. Additionally, it is necessary to confirm the safety and efficacy of the new drug and obtain regulatory approval. This requires extensive clinical trials and rigorous data analysis.

What competitive advantage does the diabetes cure have in the market?2024-01-21T19:41:02+09:00

This drug focuses on the root cause of diabetes, offering a different approach from current symptomatic treatments. It aims for complete healing of the patient, giving it a competitive edge. Specifically, the drug acts directly on the root cause of diabetes, especially targeting the abnormal stem cells believed to trigger the disease, with the goal of normalizing them. This aims to resolve diabetes and its complications fundamentally, significantly improving patients’ quality of life. It represents a new approach different from existing treatments, potentially enabling a complete cure for diabetes.

Is there a development of a new diagnostic drug for diabetes?2024-01-21T19:36:39+09:00

A new diagnostic drug is being developed to identify abnormal stem cells that cause diabetes. This could provide greater accuracy than traditional diagnostic methods, such as fasting blood sugar levels and Hemoglobin A1C (HbA1C) values.

What about the safety of the new drug?2024-01-21T19:36:03+09:00

HDAC inhibitors are already commercially available for other uses, and their safety is established. This allows for shorter development time and costs compared to completely new drugs.

When is the new drug expected to be introduced to the market?2024-01-21T19:35:13+09:00

The market launch of the new drug requires successful clinical trials and regulatory approval such as FDA. The goal is to start Phase 1 trials in 2024, and enter Phase III trials in late 2025 to early 2026. If successful, this new drug could be a significant hope for diabetes patients, potentially reducing medical expenses and socio-economic burdens. It is also expected to be effective against diabetes complications.

How is the new drug being developed?2024-01-21T19:33:37+09:00

The development involves clinical trials on the therapeutic effects of already commercially available HDAC inhibitors that is not for diabetes, using repurposing or repositioning strategies. These drugs are also expected to be effective for diabetes complications.

There are many diabetes treatment drugs on the market, so why is there a need for this new drug?2024-01-21T19:31:15+09:00

There are approximately 537 million people with diabetes worldwide, and once it develops, it is difficult to completely cure with current medical technology. This new drug aims to fully cure diabetes and its complications, unlike traditional treatments that mainly focus on controlling blood sugar levels. This could improve the quality of life for patients and potentially reduce healthcare costs.

What are the features of this treatment drug?2024-01-21T19:29:15+09:00

The research focuses on specific cells that are fundamental causes of diabetes. A new diagnostic drug is being developed to identify these cells, aiming to completely cure diabetes.

What is the purpose of developing this new drug?2024-01-21T19:28:46+09:00

The purpose of this new drug is to completely cure diabetes. Current treatments primarily focus on balancing blood sugar levels, but do not entirely cure diabetes itself.

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