Insilica

What Insilica does

Insilica is a bioinformatics and regulatory-technology company that has built an integrated three-product platform (BioBricks, ToxIndex, Sysrev) to automate regulatory-grade chemical safety assessment. The company addresses a documented toxicology capacity crisis — over 88% of EPA chemical reviews are overdue, only ~9,000 toxicologists serve North America, and ~86,000 chemicals sit in the EPA inventory. Its ToxIndex platform, commercially launched in March 2026, is an agentic AI system that uses nine specialized agents to coordinate literature retrieval, database lookups, and predictive models for metabolism, QSAR, and ADME, generating OEL/HBEL reports and REACH dossiers in hours rather than months. BioBricks provides the underlying FAIR-compliant data infrastructure with 135+ curated toxicology datasets, while Sysrev delivers human-in-the-loop expert validation producing auditable provenance chains required for regulatory submissions.

Name

Insilica

Legal name

Insilica, LLC

Website

https://insilica.co

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Insilica builds AI-driven toxicology software (BioBricks, ToxIndex, Sysrev) that automates regulatory-grade chemical safety assessments for regulatory agencies and chemical manufacturers, reducing evaluation timelines from months to hours.

Ownership category

akta.pro rank

Product category

Computational Toxicology Software

NAICS

Testing Laboratories and Services (541380), Testing Laboratories and Services (54138)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

Chemical Hazard Risk Assessment (Residues, Toxins, Adulterants) (AFALAOAB), Method Development & Validation (ICH/USP) (HLAGADAB)

Keywords

• Computational toxicology
• Chemical safety assessment
• Regulatory risk assessment
• Toxicology data infrastructure
• Agentic AI platform

Headquarters

HQ city

Bethesda

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. ToxIndex Platform Subscription: Regulatory-grade chemical safety report generation platform. Generates OEL/HBEL reports and REACH dossiers. Assessment time reduced from months to hours.
2. Data Infrastructure (BioBricks): Curated toxicology datasets provided as FAIR-compliant data infrastructure, powering analysis and eliminating data wrangling.
3. Expert Validation Services (Sysrev): Human-in-the-loop validation services where toxicologists review and validate AI outputs for regulatory submissions.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Insilica sells an integrated three-product platform for regulatory-grade chemical safety assessment. ToxIndex uses agentic AI to transform a single query into complete risk assessments, OEL/HBEL reports, REACH dossiers, and Data Evaluation Records in hours rather than months. BioBricks provides the underlying FAIR-compliant data infrastructure (135+ curated toxicology datasets), and Sysrev delivers human-in-the-loop expert validation producing the auditable trails that regulatory submissions require.

Product overview

Insilica offers an integrated three-product platform for automated chemical safety assessment: BioBricks provides curated data infrastructure with 135+ toxicology datasets; ToxIndex delivers automated risk assessments using specialized AI agents that coordinate literature retrieval, database lookups, and QSAR/ADME models; Sysrev provides expert validation through human-in-the-loop review. Together these products form end-to-end automation from evidence synthesis through regulatory submission.

Differentiator

Problem solved

Functional benefit

Brands

• BioBricks: Data infrastructure for chemical safety. Curated toxicology datasets (135+ and growing) aggregated into a single FAIR-compliant, queryable schema.
• ToxIndex
• Sysrev

Products and services

• ToxIndex Agentic AI platform for chemical safety assessment that turns a single query into a regulatory-grade risk assessment, OEL/HBEL report, REACH dossier, or Data Evaluation Record. Uses nine specialized AI agents to coordinate literature retrieval, database lookups, and QSAR/ADME/metabolism models. Built for toxicologists at regulatory agencies, chemical manufacturers, pharmaceutical companies, and research consortia.
• BioBricks FAIR-compliant data infrastructure providing 135+ curated toxicology datasets in queryable format, eliminating months of data wrangling and powering Insilica's AI models and ToxIndex platform.
• Sysrev Human-in-the-loop expert validation platform where toxicologists review and validate AI-generated outputs, catching errors and producing the defensible audit trails required for regulatory submissions.

Quantifiable outcome

• Assessment time reduced from months to hours
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• Johns Hopkins Bloomberg School of Public HealthcoreStrategic or Co-development Partner · 4 June 2026Dr. Thomas Hartung, Professor at Johns Hopkins Bloomberg School of Public Health, co-authored the Evidence-based AI framework paper with Insilica CEO Dr. Thomas Luechtefeld. Dr. Hartung described ToxIndex as 'the most credible answer I have seen to the hallucination problem in high-stakes science.'
• NICEATM (National Toxicology Program's Interagency Center for Evaluation of Alternative Toxicological Methods)coreStrategic or Co-development Partner · 1 January 2023NICEATM is helping guide technology development for the BioBricks-OKG knowledge graph. They are addressing needs in toxicology space for a data ecosystem to integrate new approach methodology (NAM) technologies spanning in vitro, in silico, and in chemico methods.
• ONTOX Project (EU Horizon)coreStrategic or Co-development Partner · 1 January 2021EU Horizon funded project for building ontologies into toxicology. Insilica's BioBricks.ai acts as the big data platform for ONTOX, providing data infrastructure for non-animal toxicology methods development.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Simulations Plus (Certara): Provides AI-driven ADMET, QSAR, and physiologically-based pharmacokinetic modeling software widely used for chemical and drug safety assessment. Closely comparable to Insilica's ToxTransformer and ToxIndex products, which similarly apply computational models to predict toxicity endpoints and generate regulatory-grade reports.
• Lhasa Limited: Not-for-profit organization offering Derek Nexus and Sarah Nexus, knowledge-based expert systems for toxicity prediction and mutagenicity assessment widely used by pharmaceutical and chemical companies. Directly comparable as an established computational toxicology platform targeting the same regulatory submission workflows as Insilica's ToxIndex.
• Instem: Supplies SaaS solutions for preclinical and toxicology workflows including study management, data capture, and SEND submissions, with acquired QSAR assets (Leadscope, MultiCASE). Comparable as a software vendor serving the same toxicology customers and integrating computational safety assessment with regulatory data management, mirroring Insilica's BioBricks + ToxIndex + Sysrev stack.

Emerging players

• Toxys: Dutch biotechnology company offering in vitro and in silico toxicology services, including reporter-based assays and computational tools for developmental and reproductive toxicology. Partially comparable as a non-animal toxicology provider that combines experimental and computational methods, intersecting with Insilica's alternative methods focus.

Broad incumbents

• Charles River Laboratories: Global CRO with a large safety assessment business delivering in vivo and in vitro toxicology services to pharmaceutical, chemical, and consumer-products clients. Comparable as a broader incumbent offering the same end customer outcomes (regulatory safety assessment) via services rather than software, but at a different scale and delivery model.
• Labcorp Drug Development: Operates one of the largest CRO safety assessment and toxicology service businesses globally, serving pharmaceutical and chemical clients. Comparable as an incumbent serving the same regulatory customer workflows, with potential to add AI-driven assessment capabilities that could compete with Insilica's ToxIndex.
• Inotiv: Contract research organization providing toxicology, discovery, and research models services to pharmaceutical and chemical clients. Comparable as an incumbent toxicology services provider whose enterprise customer relationships could be leveraged to introduce in-house AI-driven assessment competing with Insilica.
• Schrödinger: Applies physics-based and AI computational chemistry platforms to drug discovery and materials science, with growing interest in predictive toxicology and ADMET. Comparable as an AI-driven scientific platform whose chemistry and biology modeling stack overlaps with Insilica's computational toxicology positioning, albeit with a much broader drug discovery focus.
• Dassault Systèmes BIOVIA: Provides scientific informatics platforms for chemistry, biology, and materials research including toxicology data management and QSAR tools. Comparable as an established scientific software suite that addresses similar chemical safety and life sciences R&D workflows, with potential to integrate AI agents comparable to Insilica's ToxIndex.

Others

• Elsevier (Reaxys): Provides one of the largest chemistry and regulatory literature databases, including Reaxys and Embase, which Insilica's ToxIndex agents query among its 2,000+ data sources. Adjacent as a critical data and content provider underpinning Insilica's evidence-gathering workflows rather than a direct competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• GitHubgithub.com/biobricks-ai
• LinkedInlinkedin.com/company/insilica

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds6 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Insilica