Inotiv

Inotiv, Inc. (Nasdaq: NOTV) is a nonclinical contract research organization (CRO) headquartered in West Lafayette, Indiana. In its Form 10-K for the fiscal year ended September 30, 2025 the company describes itself as "a leading contract research organization ('CRO') dedicated to providing nonclinical and analytical drug discovery and development services" to the pharmaceutical and medical device industries, alongside a research model products business.^[S1] The company was incorporated in 1974 as Bioanalytical Systems, Inc. and changed its name to Inotiv, Inc. on March 18, 2021.^[S1] This profile summarizes the services, sites, stated compliance information, and company facts most relevant to US sponsors.

Nonclinical services relevant to US drug developers

Discovery through IND-enabling support

Inotiv reports two business segments: Discovery and Safety Assessment (DSA) and Research Models and Services (RMS).^[S1] Its Discovery and Translational Sciences group lists disease pharmacology (in vitro and in vivo), discovery bioanalysis and biomarkers, cell and molecular biology, predictive and computational toxicology, toxicogenomics, targeted proteomics, histology and pathology, and consultative drug discovery programs.^[S8] An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.^[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed.

Toxicology and safety pharmacology

The company states that it "provides general toxicology studies under internationally recognized regulatory guidelines for the safety evaluation of your small molecule, biotherapeutic drug candidate, medical device, or non-pharma product."^[S3] Listed study types include acute single-dose toxicity, repeat-dose range-finding, subchronic and chronic toxicity, carcinogenicity including the transgenic rasH2 mouse model, exploratory toxicology, genetic toxicology (GLP and non-GLP), and developmental and reproductive toxicology.^[S3] Safety pharmacology is offered as a separate service line covering telemetered cardiovascular measurements (blood pressure, heart rate, ECG), a CNS functional observational battery described as a modified Irwin's test, rodent respiratory plethysmography, and large-animal cardiopulmonary telemetry, with reference to the ICH S7A and S7B guidelines.^[S4]

Species available for toxicology work should be confirmed with the company for each program; the 10-K describes an animal production business covering research models, and the research models pages list rodents, rabbits, and genetically engineered models.^[S1][S9] Deliverable formats such as SEND datasets and eCTD-ready reports were not confirmed on the pages reviewed for this profile and should be specified in the study contract.

DMPK, bioanalysis, and pathology

The DMPK service line lists bioanalytical method development, excretion studies, plasma protein binding, CYP inhibition assays, targeted proteomics, reaction phenotyping, metabolite identification, PK and TK analyses, bioavailability and bioequivalence evaluation, and drug-drug interaction risk assessment.^[S5] The company markets its small molecule bioanalysis as GLP, using LC-MS/MS and HPLC/UPLC platforms; the reviewed page does not identify whether the FDA, EPA or OECD regime is meant with dedicated sample management, metrology, and quality assurance teams.^[S6] Pathology services are provided by pathologists certified by the American College of Veterinary Pathologists and include primary review and peer review, on-site necropsy, histology, clinical pathology and biomarker services, medical device pathology, digital pathology, and immunohistochemistry.^[S7]

Research models and services

Alongside its services business, Inotiv supplies research models. The research models pages list genetically engineered models and services (GEMS), full-spectrum health monitoring, custom antibody production, biospecimen services, contract breeding, genetic testing, and surgical services.^[S9] In fiscal 2025 the Research Models and Services segment accounted for $325.1 million of $513.0 million in total revenue, with Discovery and Safety Assessment accounting for $187.9 million.^[S1]

Therapeutic areas

Inotiv uses the same ten therapeutic areas across its discovery, toxicology, and research model pages: cardiovascular, gastrointestinal, hepatic, infectious disease, inflammation and immunology, metabolic and diabetic disease, neuroscience, pulmonary, oncology, and renal.^[S8] Named models on the pages reviewed include the transgenic rasH2 mouse used in carcinogenicity studies^[S3] and genetically engineered models supplied through the GEMS program.^[S9] Individual disease models, including combined chronic kidney disease and diabetic nephropathy models, were not listed on the pages reviewed and should be confirmed with the company.

Quality, compliance, and animal welfare (as stated by the company)

GLP. The 10-K states that DSA segment services use "both Good Laboratory Practice ('GLP') and non-GLP" work.^[S1] The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.^[S1] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.^[R2]

Accreditation and registration. The 10-K states that "all of Inotiv's animal production facilities are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International"^[S1] and that "in addition to being licensed by the USDA as a research facility where applicable, we have registered assurances with the NIH."^[S1] The AAALAC statement is limited to animal production facilities; sponsors should confirm the accreditation status of the specific site that will run their study. AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,^[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;^[R4][R5] none of these establishes GLP compliance, which applies to individual studies.^[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.^[R6]

Animal welfare program. The company's animal welfare statement says that "each operating establishment will maintain an animal welfare and ethical review body (AWERB) or an institutional animal care and use committee (IACUC) where required," describes a commitment to the 3Rs (replacement, reduction, refinement), and states that the company is a signatory to the Concordat on Openness on Animal Research.^[S10] This profile does not evaluate the company's animal care program; the statements above are the company's own.

Company facts

Matters disclosed in the company's SEC filings

Because Inotiv is a public company, some matters that a sponsor would ordinarily have to ask about are disclosed in its SEC filings. In the fiscal 2025 Form 10-K the company states that management identified conditions that raise substantial doubt about its ability to continue as a going concern, and it concluded that its disclosure controls and internal control over financial reporting were not effective as of September 30, 2025.^[S1] The filing also describes the June 2022 decision to close the canine breeding facility in Cumberland, Virginia acquired with Envigo RMS, following a Department of Justice criminal investigation that was resolved through a June 2024 resolution agreement and plea agreement under which a compliance monitor remains in place.^[S1] The company further discloses a cybersecurity incident in August 2025 that led to three putative class actions, a completed "Phase One" site optimization plan under which several facilities were exited, and a dependence on imported non-human primates as a risk factor.^[S1] These are the company's own disclosures as of the filing date; sponsors should check the most recent 10-K and 10-Q before contracting.