InSphero AG is a Switzerland-based preclinical service provider specializing in three-dimensional human liver model technologies.
Leveraging its proprietary platforms, the company offers contract research services that accurately recapitulate pathological conditions such as drug-induced liver injury (DILI), fatty liver disease, and liver fibrosis.
In Japan, InSphero AG’s technologies and technical consultation services are supported through its distributor, Cosmo Bio.
This section provides an overview of InSphero AG’s preclinical service capabilities, representative disease models, and relevant applications.
InSphero AG’s contract research services utilizeproprietary 3D InSight™ Liver Microtissues to assess the risk of drug-induced liver injury (DILI) in highly human-relevant, three-dimensional biomimetic liver models. Unlike conventional two-dimensional cultures, these microtissues preserve liver-specific microarchitecture and incorporate multiple human hepatic cell types in co-culture, enabling the generation of physiologically relevant toxicity data.
The platform is optimized for high-throughput screening, allowing large compound libraries to be evaluated within a short timeframe and supporting early go/no-go decision-making in drug development.
Following analysis, comprehensive study reports are provided, delivering actionable safety data directly applicable to preclinical development and clinical risk assessment.
Beyond DILI assessment,InSphero AG supports drug discovery research through advanced liver disease modeling.For chronic liver diseases such as MASLD (NAFLD) and MASH (NASH), the company offers disease-specific 3D liver microtissue models that recapitulate pathological states and enable direct comparison with healthy controls.
These models allow simultaneous evaluation of efficacy and safety while providing mechanistic insights into disease biology and compound responsiveness.
Their uniform, scalable design is well suited for automated workflows, large-scale screening, and integration with advanced analytical approaches, including next-generation sequencing–based readouts.
InSphero AG also providestranslational toxicology studies using 3D InSight™ Liver Microtissues derived from both human and animal sources, enabling cross-species comparative assessments.This approach allows evaluation of how toxicological responses observed in preclinical animal models translate to human biology, thereby reducing uncertainty and risk during clinical transition.
Published studies have demonstrated high accuracy in detecting compounds associated with human hepatotoxicity, enabling early identification of safety liabilities that are often overlooked in conventional 2D or single-species models.
Such multi-species, three-dimensional comparative modeling enhances confidence in safety assessment across the drug discovery and development pipeline.
The 3D InSight™ Human Fatty Liver (Steatosis) Model employsthree-dimensional microtissues composed of multiple human hepatic cell types.By inducing lipid accumulation under free fatty acid and high-glucose conditions, the model reproduces key pathological features of clinically observed fatty liver disease.
Both microvesicular and macrovesicular lipid droplet formation are observed within hepatocytes, enabling in vitro assessment of metabolic dysfunction relevant to MASLD/MASH.
Preservation of cell–cell interactions within the 3D architecture provides data with higher human relevance than conventional 2D culture systems, supporting efficacy testing, mechanism-of-action studies, and toxicity evaluation.
In addition, InSphero AG offersa 3D InSight™ Human Liver Fibrosis Model, which incorporates hepatic stellate cells alongside hepatocytes and other liver cell populations.Fibrosis is induced through stimuli such as TGF-β1, leading to activation of stellate cells and excessive production of extracellular matrix components, including collagen. This model closely mimics key aspects of liver fibrogenesis and is widely used as an in vitro human platform for evaluating antifibrotic drug candidates and investigating fibrosis-related mechanisms.
No public nonclinical case examples are currently disclosed.
| Address | Toyo Ekimae Building, 2-2-20 Toyo, Koto-ku, Tokyo, Japan (Distributor: Cosmo Bio Co., Ltd.) |
|---|---|
| Tel | +81 (3) 5632-9610 |
| Website | https://insphero.com/ |
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.
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.
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 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.
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.
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.