Simulations Plus

What Simulations Plus does

Simulations Plus, Inc. (NASDAQ: SLP) is a 1996-founded developer of modeling and simulation software for pharmaceutical and biotechnology drug development, headquartered in Research Triangle Park, Durham, North Carolina. The company builds mechanistic and AI-enabled platforms spanning the full drug development continuum: GastroPlus for PBPK/PBBM absorption modeling, MonolixSuite for population PK/PD pharmacometrics, ADMET Predictor for ML-based ADMET property prediction (175+ properties), DILIsym for quantitative systems toxicology (drug-induced liver injury), Thales for quantitative systems pharmacology, and the Pro-ficiency platform (acquired June 2024 for ~$100M) for clinical trial training and performance management. The portfolio is complemented by add-on modules (MedChem Designer, MembranePlus, DDDPlus, IVIVCPlus, PBPKPlus, PDPlus, PKPlus), disease-specific QSP library models (OBESITYsym, NAFLDsym, IPFsym, ILDsym, etc.), and consulting service packages (Consult + Coach, First-in-Human Simulator, Pulmonary Package, NAMVantage).

The company monetizes through enterprise annual site licensing (per-seat and site-wide subscriptions) and a consulting services practice staffed by pharmacometricians and regulatory experts. Roughly 60% of revenue is recurring software licensing and approximately 40% is professional services, with software revenue of ~$14.6M and services revenue of ~$9.7M in Q2 FY2026. Go-to-market is primarily enterprise direct sales complemented by an event-driven motion (ACoP, ISSX, ACCP, DPHARM, AAPS), a self-serve evaluation program, a University+ academic program, and a Consult + Coach bundle that ties free 3-month software trials to consulting engagements. The company reports 280+ active customers, including 19 of the top 20 global pharmaceutical companies, and operates across North America, Europe, and Asia.

Strategic positioning rests on validated mechanistic models developed over 30+ years, seven concurrent FDA-funded research collaborations, and fourteen regulatory agencies trained on its software. The company is investing in an AI-native Composer platform built with NVIDIA BioNeMo Agent Toolkit and CUDA-optimized nvQSP solvers, and in 2026 entered strategic AI collaboration programs with three large pharmaceutical companies and a co-development partnership with Lonza and the U.S. FDA. Simulations Plus has entered a definitive agreement to be acquired by healthcare-focused private equity firm Altaris, LLC for approximately $375 million ($18.50 per share) in an all-cash transaction expected to close in Q4 2026, at which point the company will be combined with Altaris portfolio company Chemical Computing Group and become privately held.

Name

Simulations Plus

Legal name

Simulations Plus, Inc.

Website

https://simulations-plus.com

Company type

Public

Founded year

1996

Operating status

Operating

Headcount range

101–250 employees

Short description

Simulations Plus develops mechanistic and AI-enabled modeling and simulation software (PBPK, PK/PD, QSP, QST, ADMET) for pharmaceutical and biotechnology drug development, serving 280+ clients including 19 of the top 20 global pharma companies via enterprise licensing, consulting services, and clinical trial training.

Ownership category

akta.pro rank

Product category

Pharmaceutical R&D Modeling and Simulation Software

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Computer Systems Design and Related Services (54151)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Prepackaged Software (7372)

akta.pro primary industry

Clinical Pharmacology & Pharmacometrics (Modeling & Simulation) (HLAIALAG)

akta.pro secondary industries

AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO), In Silico / Computational Toxicology & PK/PD Modeling (HLAGAFAM), Cheminformatics & Molecular Modeling / CADD (HLAGAJAE)

Keywords

• Pharmacokinetic simulation software
• ADMET property prediction
• Model-informed drug development
• Quantitative systems pharmacology
• Pharmaceutical consulting services

Headquarters

HQ city

Lancaster

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Software Licensing: Recurring software licensing of flagship simulation platforms including GastroPlus, MonolixSuite, ADMET Predictor, DILIsym, Thales, and Pro-ficiency. Revenue is recurring in nature with annual renewal cycles. Software revenue represented approximately 60% of total revenue in Q2 2026 at $14.6 million.
2. Consulting Services: Consulting engagements staffed by pharmacometricians and regulatory experts providing services across discovery, development, clinical operations, and commercialization phases. Services revenue represented approximately 40% of total revenue in Q2 2026 at $9.7 million, growing 8% year-over-year.

Pricing tiers

Go-to-market motion4 records

Distribution channels4 records

Marketing channels7 records

Core offering

Simulations Plus develops and licenses computational modeling and simulation software (GastroPlus, MonolixSuite, ADMET Predictor, DILIsym, Thales, Pro-ficiency) for pharmaceutical and biotechnology drug discovery, development, and clinical operations. The company also provides complementary consulting services staffed by pharmacometricians and regulatory scientists, covering discovery through commercialization phases, including specialized packages such as Consult + Coach, First-in-Human Simulator, NAMVantage, and the Pulmonary Package.

Product overview

Simulations Plus offers a comprehensive portfolio of model-informed drug development (MIDD) software and services spanning discovery through commercialization. The core product suite includes GastroPlus® (PBBM/PBPK absorption and pharmacokinetics modeling), MonolixSuite™ (population PK/PD pharmacometrics), ADMET Predictor® (AI/ML-based ADMET property prediction), DILIsym® (Quantitative Systems Toxicology for liver injury), Thales™ (Quantitative Systems Pharmacology platform), and Pro-ficiency® (clinical trial training and performance management, acquired 2024). These are complemented by specialized add-on modules (MedChem Designer, MembranePlus, DDDPlus, P-PSD), disease-specific QSP library models (OBESITYsym, NAFLDsym, IPFsym, ILDsym, etc.), and consulting service packages (Consult + Coach, Pulmonary Package, NAMVantage). The company is developing an AI-native Composer platform integrating mechanistic modeling with agentic AI capabilities via NVIDIA BioNeMo. Services include Discovery, Development, Clinical Operations, and Commercialization consulting, supported by training programs and workshops.

Differentiator

Problem solved

Functional benefit

Brands

• GastroPlus: Mechanistically based simulation software for PBPK/PBBM modeling of drug absorption and pharmacokinetics
• MonolixSuite
• ADMET Predictor
• DILIsym
• Thales
• Pro-ficiency

Products and services

• GastroPlus®

Quantifiable outcome

• Up to 75% reduction in time required for end-to-end QSP modeling
• +2 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability8 records

Feature10 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• Chemical Computing GroupcoreOthers · 16 June 2026Upon closing of the Altaris acquisition, Simulations Plus will be combined with Chemical Computing Group (an existing Altaris portfolio company providing advanced molecular design software) to create an integrated platform for AI-driven drug development and molecular design.
• NVIDIAcoreTechnology or Integration · 6 May 2026Technical collaboration to enable GPU-accelerated simulation and AI-assisted workflows for computationally intensive modeling applications in drug development. Combines Simulations Plus validated scientific engines (PBPK, PK/PD, QSP) with NVIDIA AI infrastructure including BioNeMo platform. Testing shows up to 75% reduction in time required for end-to-end QSP modeling.
• LonzacoreStrategic or Co-development Partner · 21 April 2026Funded research collaboration with U.S. FDA to develop and validate mechanistic predictive framework for amorphous solid dispersion (ASD) drug products. Lonza leads experimental work while Simulations Plus develops IVIVE frameworks using DDDPlus and GastroPlus platforms to support virtual bioequivalence assessments.
• U.S. FDAcoreStrategic or Co-development Partner · 21 April 2026Ongoing research collaboration to advance predictive frameworks for drug products and food chemical safety assessments. FDA provides funding and curated toxicological datasets for training and validation of AI/ML safety models. Supports model-informed drug development and new approach methodologies (NAMs).
• Three Large Pharmaceutical CompaniescoreStrategic or Co-development Partner · 26 March 2026Strategic collaboration programs to advance AI-enabled workflows across the drug development lifecycle. Programs integrate Simulations Plus AI agents into model-informed drug development workflows using GastroPlus, MonolixSuite, ADMET Predictor, and Thales platforms, enabling natural language interaction and automated data processing.
• Eli LillycoreStrategic or Co-development Partner · 24 March 2026Collaboration on AI-driven drug discovery mentioned as contributing to strategic positioning and stock performance, indicating active partnership in advancing AI-enabled drug development.
• National Institute of Environmental Health Sciences (NIEHS)minorStrategic or Co-development Partner · 10 February 2026Extended collaboration applying Simulations Plus software engines to help design, validate, and benchmark new experimental systems for chemical safety evaluation. Part of national effort to modernize chemical risk assessment through new approach methodologies.
• University of BathminorStrategic or Co-development Partner · 5 March 2024Joint recipient of FDA grant recognizing and supporting collaborative work in model-informed drug development.
• University of PittsburghminorStrategic or Co-development Partner · 29 March 2022Research partnership for development and validation of BIOLOGXsym software for macromolecule liver safety assessment, integrating human-on-a-chip systems for improved drug safety evaluation.
• University of North CarolinaminorStrategic or Co-development Partner · 29 March 2022Research partnership for development and validation of BIOLOGXsym software for macromolecule liver safety, expanding quantitative systems toxicology applications to biologics and gene therapies.

Scale indicators11 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Certara: Certara is the most direct competitor, offering biosimulation software (GastroPlus's primary competitor for PBPK), regulatory science consulting, and model-informed drug development services to the same pharmaceutical and biotech customer base.
• Schrödinger: Schrödinger provides physics-based and AI-driven molecular simulation software for drug discovery, overlapping with ADMET Predictor and MedChem Designer and targeting similar pharmaceutical computational chemistry and discovery customers.
• Chemical Computing Group (CCG / MOE): CCG develops the Molecular Operating Environment (MOE) platform for drug discovery and molecular design; it is being combined with Simulations Plus under Altaris and competes directly with ADMET Predictor and MedChem Designer in cheminformatics.

Broad incumbents

• Dotmatics: Dotmatics offers a broad scientific R&D informatics platform (LIMS, ELN, data management) for pharma/biotech, providing overlapping data infrastructure for model-informed drug development customers.
• Instem (now part of Perceptive): Instem/Perceptive provides life science R&D software including preclinical informatics, regulatory submissions, and study management — adjacent to Simulations Plus's preclinical and regulatory modeling offerings.

Emerging players

• Genedata: Genedata provides enterprise informatics platforms for biopharma R&D (screening, biologics, biomarker analysis), serving similar pharma/biotech customers with workflow software that complements mechanistic modeling.
• OpenEye Scientific (Cadence Design Systems): OpenEye develops molecular modeling and cheminformatics software (e.g., OMEGA, FEP+) used in drug discovery, overlapping with Simulations Plus's ADMET Predictor and computational chemistry offerings.
• Insilico Medicine: Insilico Medicine is an AI-native drug discovery company using generative AI and end-to-end platforms to compete for pharma R&D spend that historically went to traditional PBPK/QSP modeling vendors.
• Recursion Pharmaceuticals: Recursion applies AI-driven phenotypic screening and high-throughput biology to drug discovery, representing an AI-native alternative approach that competes for pharma R&D budget allocated to model-informed discovery.

Others

• L7 Informatics: L7 Informatics provides data and workflow platforms for biopharma R&D and manufacturing; it serves as an enabling informatics layer adjacent to Simulations Plus's MIDD-focused modeling and consulting business.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/c/SimulationsPlusInc
• LinkedInlinkedin.com/company/simulations-plus-inc
• Xx.com/SimulationsPlus
• Facebookfacebook.com/SimulationsPlus

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Subsidiaries1 record

Funding overview

Funding rounds4 records

Investors2 records

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

M&A6 records

Investments

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

Frequently asked questions about Simulations Plus