Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » WAKENYAKU CO.,LTD.

WAKENYAKU CO.,LTD.

Table of Contents
Table of Contents

WAKENYAKU CO.,LTD. supports research and development across biotechnology and related disciplines. Here, we provide an overview of our nonclinical study capabilities, representative disease models, and case examples. Please use this information as a reference when selecting a CRO to conduct nonclinical studies.

Nonclinical studies undertaken by WAKENYAKU CO.,LTD.

WAKENYAKU CO.,LTD. conducts high-quality toxicology (safety), pharmacology/efficacy (PD), and pharmacokinetics (PK) studies in accordance with applicable guidelines. As a CRO, WAKENYAKU CO.,LTD. accepts contracts for pharmacology (PD), toxicology, and PK studies, performed in vitro and in vivo.

Contract Research Partners Available Through WAKENYAKU CO.,LTD.

FUJIFILM Wako Pure Chemical Corporation

Provides contract efficacy studies using PDX/CDX mouse models. Services include dosing anticancer agents in PDX mice and conducting efficacy evaluations. With an inventory of 2,700 PDX models, appropriate models can be selected for the compound based on genetic and pathological data as well as efficacy data for existing agents.

Funakoshi

Provides contract study services using domestic swine. Offerings include collection of intestinal contents, DIAAS (Digestible Indispensable Amino Acid Score) evaluations, cartilage transplantation studies in the knee joint, and gastrointestinal tract adhesion testing.

TRANS GENIC INC.

Provides nonclinical studies under licenses for genetically engineered mouse lines established and characterized at universities and research institutes. Available models include APPosk-Tg mice for Alzheimer’s disease, ProBDNF KI mice for psychiatric and neurologic diseases, SJLB mice for dementia, and IL33 Tg mice for atopic dermatitis. Comprehensive support is available from study design aligned with each disease hypothesis through high-quality data acquisition.

SetsuroTech

Provides end-to-end support for CRISPR/Cas9 genome-edited mouse creation, breeding, and phenotyping. Available assessments include blood and urine testing, toxicity studies, and safety pharmacology studies. Planning is available from the mouse-creation stage, including required animal numbers for each study. Additional support includes in vitro fertilization (IVF), natural mating, and cryopreservation of embryos and sperm.

Examples of Nonclinical Studies by WAKENYAKU CO.,LTD.

Pharmacodynamic/Pharmacology Studies (non-GLP)

Studies are conducted in an SPF environment using isocage systems and support non-GLP pharmacodynamic/pharmacology studies in mice and rats. Endpoints span antitumor efficacy, obesity, diabetes, and hypertension. Projects can be commissioned starting from a single mouse, at low cost, with rapid turnaround.

Reference: WAKENYAKU CO.,LTD. official website https://www.wakenyaku.co.jp/jtk/det.php?i=1251

Phenotypic Analysis of Genetically Engineered Animals

Phenotypic Analysis of Genetically Engineered Animals Studies are conducted in an SPF environment using isocage systems and support non-GLP pharmacodynamic/pharmacology studies in mice and rats. Assessments include general clinical observations, behavioral analysis, hematology, clinical chemistry, and gross and histopathology. Projects can be commissioned starting from a single mouse, at low cost, with rapid turnaround.

Reference: WAKENYAKU CO.,LTD. official websitehttps://www.wakenyaku.co.jp/jtk/det.php?i=1251

WAKENYAKU CO.,LTD. Company Information

Founded in 1972, WAKENYAKU CO.,LTD. has developed its business through its dealing and manufacturing divisions. The company provides researching and developing support in a variety of fields.

Address 17 Nishimizubo-cho, Ichijyoji, Sakyo-ku, Kyoto-shi, Kyoto, Japan
Tel 075-721-8111
Website https://www.wakenyaku.co.jp/

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

In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.

Pharmacology (Efficacy) StudiesDisease-Relevant Models for
Translational Drug Evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)

SMC Laboratories, Inc.

SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.

Areas of Expertise
Disease-Relevant Model Portfolio

SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.

Study Design Based on Target Biology

Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.

Support from Target Validation to Proof of Concept

With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.

Safety StudiesComprehensive Safety Assessment for
Preclinical Development
Charles River Laboratories
Reference: Charles River Laboratories official website (https://www.criver.com/)

Charles River Laboratories

Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.

Areas of Expertise
General Toxicology Across Study Designs

Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.

Non-GLP and GLP Study Support

Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.

Integrated IND-Enabling Safety Assessment

Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.

Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with
Pharmacological Response
Inotiv
Reference: Inotiv official website (https://www.inotiv.com/)

Inotiv

Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.

Areas of Expertise
Pharmacokinetic Characterization

PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.

Exposure–Response Evaluation

Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.

Integrated DMPK and Development Support

Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.

By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services