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R&D in Metabolic Diseases

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Metabolic diseases are among the most significant medical challenges in modern society. Diabetes, dyslipidemia, and obesity are representative metabolic diseases, and these conditions are often caused by lifestyle and genetic factors. In drug discovery, the development of new therapies for these diseases is advancing, and nonclinical studies play a vital role.Caused by lifestyle and genetic factorsIn many cases. In the field of drug discovery, non-clinical trials play an important role as new drugs for these diseases are developed.

Diabetes, dyslipidemia, and obesity are representative metabolic diseases, and these conditions are often caused by lifestyle and genetic factors. In drug discovery, the development of new therapies for these diseases is advancing, and nonclinical studies play a vital role. Below, through case studies in metabolic-disease drug discovery, we outline how new drug development was conducted and how nonclinical studies were implemented.

B&I Holdings Inc. Development Case Study

B&I Holdings Inc. has extensive experience in drug discovery for metabolic diseases and conducts the range of studies and evaluations required to develop therapeutics for lifestyle-related diseases. Support spans from drug discovery strategy consultation to study execution, with emphasis on the lead compound optimization stage. In particular, the company offers a robust portfolio of pharmacology studies targeting cancer and metabolic diseases and is recognized for quality and reliability.

Nonclinical Studies

B&I Holdings Inc. conducts in vivo pharmacology studies using normal and disease-model animals, as well as in vitro pharmacology studies using cultured cells. The organization has strengthened its contract research framework across five sites in Japan and overseas to support nonclinical safety testing in an integrated, end-to-end manner from discovery through development.

Reference: Bozo Research Center official websitehttps://www.bozo.co.jp/lp/souyaku/

AstraZeneca Development Case Study

AstraZeneca is actively engaged in drug discovery for obesity and Type 2 diabetes. In particular, in collaboration with Eccogene, the company is developing ECC5004, a once-daily oral GLP-1 receptor agonist. This drug is expected to provide glucose-lowering and weight-reduction effects and may represent a meaningful advance in the treatment of metabolic diseases.

Nonclinical Studies

Nonclinical studies for ECC5004 were conducted in the United States to evaluate efficacy and the safety profile. These studies confirmed the desired effects, and the program is currently in Phase I clinical trials.

Reference: AstraZeneca official websitehttps://www.astrazeneca.co.jp/media/press-releases1/2023/2023112701.html

Summary

Nonclinical studies are an essential step in the discovery of therapies for metabolic diseases. As shown in the cases of B&I Holdings Inc. and AstraZeneca, these studies aim to establish the efficacy and safety of new drug candidates and ultimately to deliver better treatment options for patients. The importance of nonclinical studies will continue to grow.

3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation

SMC Laboratories, Inc.

Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)

SMC Laboratories, Inc. has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.

Consult study design and disease model development
with SMC Laboratories, Inc.

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Safety Studies
Comprehensive Safety Evaluation for FIH Applications

Labcorp Holdings Inc.
(Labcorp Drug Development)

Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)

Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.

Consult Labcorp Holdings Inc.
Discuss GLP/ICH-compliant study design for your FIH submission.

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Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation

PhoenixBio Co., Ltd.

Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)

PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.

Consult Phoenix Bio for PK/PD analysis with a clinical focus

Phoenix Bio.
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