At InSphero, we have set out to solve a fundamental problem in drug development: the disconnect between preclinical safety testing and human clinical outcomes. Today, as we look at the evolution of our platform, from our gold-standard 3D InSight™ DILI service to the recent launch of our gastrointestinal toxicity screening platform ,we see not just a collection of products, but an integrated strategy coming to life.
The End to end vision
Drug-induced toxicity doesn't respect organ boundaries. A compound that causes liver injury may also trigger gastrointestinal damage, cardiac arrhythmias, or neurotoxicity. Yet for too long, pharmaceutical safety teams have been forced to work with fragmented solutions: one vendor for liver models, another for cardiac assays, a third for gastrointestinal (GI) testing; each with different protocols, data formats, and quality standards. The result is inconsistent data, operational complexity, and gaps in safety coverage that only become apparent in late-stage clinical trials or, worse, post-marketing.
Our vision is to become the world's most trusted partner for human-relevant, AI-powered in vitro drug development, offering a comprehensive safety pharmacology platform under a single partnership. One contract. One quality standard. One integrated dataset that enables confident go/no-go decisions across multiple organ systems.
Extending beyond DILI
Our 3D InSight™ DILI platform has become the industry gold standard for in vitro liver toxicity testing. With over 17 years of refinement, it delivers the reproducibility, scalability, and predictive power that pharmaceutical companies need to make early safety decisions with confidence. Our models have successfully flagged 8 out of 10 FDA-withdrawn drugs for hepatotoxicity, a benchmark that no competing platform has matched.
Figure 1. InSphero's Integrated 3D In Vitro Safety Platform - from drug candidate input through multi-organ safety profiling to decision-ready regulatory outputs.
But liver safety is just the beginning. Our corporate strategy centers on expanding this proven operational model to additional safety-critical organ systems; gastrointestinal, cardiac, and neural, creating a comprehensive safety portfolio that addresses the full spectrum of drug-induced toxicities driving clinical attrition. The objective is clear: build a comprehensive safety pharmacology portfolio spanning the three major safety organs, providing customers with an integrated solution
The GI Tox platform – Integration in action
The launch of our 3D InSight™ DIGIT (Drug-Induced Gastrointestinal Toxicity) platform in March 2026 is a pivotal milestone in this strategy, and a direct product of our November 2025 acquisition of DOPPL SA, a Lausanne-based EPFL spin-off and innovator in organoid technologies.
GI toxicity is one of the most common causes of dose limitations and late-stage clinical failures. Yet pharmaceutical safety teams have historically lacked a reliable, scalable in vitro tool to flag these risks early. DIGIT changes that equation by combining patient-derived human intestinal organoids, cultured on the Gri3D® platform, with automated phenotypic imaging at single-organoid resolution, delivering quantitative IC₅₀ values and functional readouts in decision-ready reports.
Figure 2. Accelerate your go/no-go decisions with patient-derived human intestinal organoids, enabling earlier prediction of GI cytotoxicity liabilities and fluid secretion liabilities.
What makes this launch strategically significant is how we built it. DOPPL brought world-class expertise in patient-derived gut models and the proprietary Gri3D® hydrogel microcavity platform. We contributed 17 years of experience operating standardized, batch-executed safety screening. Rather than simply rebranding DOPPL's capabilities, our combined teams redesigned the intestinal toxicology offering around InSphero's proven operational model, standardized protocols, automated analysis, and comprehensive reports that pharmaceutical teams can integrate into routine workflows.
Key Features of the 3D InSight™ DIGIT
- Patient-derived organoids: Human small intestinal organoids recapitulating native epithelial architecture.
- Standardized execution: ensuring consistent, comparable data quality across studies.
- Scalable throughput: Gri3D® technology with automated imaging at single-organoid resolution.
- Decision-ready outputs: Quantitative IC₅₀ values with optional functional swelling readouts.
- Integrated safety profiling: Seamlessly combined with 3D InSight™ DILI for hepatic + GI safety. One partner, one contract.
Laying the Foundation – The Technology Platform
- Akura™Spheroid Plates: Our proprietary 96- and 384-well microplate technology enables high-throughput, automation-compatible screening with exceptional well-to-well uniformity, the production engine behind our liver microtissues and future safety models.
- Gri3D®Organoid Platform: Acquired through DOPPL, this hydrogel microcavity technology enables the formation of uniform, patient-derived organoids with high reproducibility. It underpins our DIGIT platform and will expand to additional organoid applications across organ systems.
- AI-Powered Analytics: We are building a data science layer on top of our biology platform, integrating physicochemical descriptors, dose information, and biological readouts to create adaptive, context-sensitive risk profiles and interactive reporting tools.
In the pipeline – Cardiac and Neural safety
Our roadmap does not stop with liver and GI. We are actively developing cardiac and neural safety models to complete our comprehensive safety pharmacology portfolio, addressing the urgent regulatory and industry need for predictive, human-relevant alternatives in cardiotoxicity and neurotoxicity assessment.
We are taking a deliberate, sequenced approach, combining internal development with strategic acquisitions where appropriate, to ensure we bring the right models to market with the scientific excellence our customers expect. The goal is clear; pharmaceutical companies should be able to profile a drug candidate across liver, GI, cardiac, and neural safety endpoints through a single InSphero partnership.
Figure 3. Gain human-relevant neurotoxicity insights with 3D InSight™ neural microtissues, iPSC-derived human neural spheroids (glutamatergic/GABAergic neuron-astrocyte tri-culture)
The Regulatory Imperative
This strategy is aligned with a fundamental shift in the regulatory landscape. The FDA Modernization Act 2.0, recent FDA guidance on reducing non-human primate use, and the NIH's Standardized Organoid Modeling (SOM) Institute all signal a clear direction: the future of preclinical safety testing is human-relevant, in vitro, and standardized.
We are not waiting for this future to arrive. By establishing standardized, validated, multi-organ safety platforms now, we are positioning ourselves and our customers to lead the transition away from animal testing toward more predictive, ethical, and efficient drug development.
One Partner, One Vision, Better Therapeutics
The launch of our DIGIT platform, powered by the DOPPL acquisition, is proof that this vision is achievable. It is not just about adding new models to a catalogue, it is about genuine integration, operational excellence, and a relentless focus on delivering decision-ready data that helps our customers bring safer, more effective medicines to patients.
We are excited about the journey ahead. As we expand into cardiac and neural safety, deepen our AI capabilities, and continue to refine our operational excellence, we remain committed to our founding mission: empowering researchers to reach their full potential in the quest for breakthrough therapies through reliable, scalable, and reproducible 3D in vitro models. The future of safety pharmacology is human-relevant, multi-organ, and integrated. We are building that future, one model at a time.
