Azunic
Loading0%
Animal-Free Toxicology

Know the risk.Skip the animals.

ZeroAnimals harmed
12-16 weeksRegulatory Tox Results

Human-relevant toxicity data for regulatory filing generated in weeks, not years – with no animals harmed.

Aligned withFDA Modernization Act 2.0ICCVAM / NICEATM
Azunic mark

A future where everyone who needs treatments gets them. Because the science got the biology right from the start.

The Problem
90+%

Over 90% of drugs fail in clinical trials that looked promising in animal models.

Companies lose decades and billions. Patients are tested with the wrong medicines.

THE HUMAN COST

Despite showing safety and efficacy in animals, clinical drug failures occur due to fundamental differences in biology. These failures ultimately delay patients receiving the medications they need.

The animal cost

Millions of animals — mice, rats, rabbits, dogs, primates — are bred and used in these tests every year. Most of this suffering is in vain.

THE FINANCIAL COST

Drug development now costs $2.6B on average and takes 10–15 years. Roughly half of this cost is from drug failures.

Predictive Accuracy

Built on 75–85% predictive accuracy

Validated against real human outcomes, not just historical animal-model correlation — across hepatic, renal and cardiac safety panels.

The number that changes everythingNAM aligned

Zero

test animals harmed

Zero animals tested.
100% human-relevant data.

Every compound we evaluate produces human-relevant data without sacrificing a single animal.

The FDA Modernization Act 2.0 removed the animal testing mandate in 2022. Azunic's platforms were designed around that shift from day one.

Fully NAM-aligned. New Approach Methodology — the future of safety testing.
Solutions

Built for every stage of drug development

01In Silico

Computational Assessment

AI-driven QSAR and PBK models trained on human data to predict ADMET profiles before any lab work begins.

QSAR ensemble evaluates compound structures against human clinical outcomes. PBK simulation predicts dose-response in human organ compartments.

02In Vitro

Biological Validation

Advanced 3D human tissue culture systems are used to determine the toxicity risks of new drug candidates.

Our hepatic, renal, cardiac, intestinal, neural, and lung organoids are derived from biobanked human iPSC under full ethical consent.

03Guidance

Regulatory Package

Azunic doesn’t stop at the data. We coordinate your regulatory submission for IND/CTN, translating our findings into the package regulatory reviewers expect.

Complete regulatory-ready submissions aligned with FDA Modernization Act 2.0, ICH M7/S7A/S7B, and OECD Test Guidelines.

Early Stage

Rapid Screening

High-throughput compound triage in weeks. Kill or advance candidates before investing in full development.

From SMILES input to go/no-go in under 3 weeks. Tiered screening layers in silico flagging with targeted organoid confirmation.

Late Stage

Safety Deep-Dive

Mechanistic toxicology studies on target organs: liver, kidney, cardiac, CNS.

Multi-organ mechanistic study maps toxicity thresholds, reversibility, and pathway mechanisms for IND filing.

Final Stage

Regulatory Submission

Azunic handles IND/CTN submission coordination end to end, so your team can move from tox results to filing without juggling vendors or reformatting data.

Azunic handles IND/CTN submission coordination end to end, so your team can move from tox results to filing without juggling vendors or reformatting data.

Technology

The science is ready.
The regulators agree.

The FDA Modernization Act 2.0 explicitly enables non-animal testing methods. Azunic's platform defines a five-step pipeline that focuses on successful regulatory review.

01
Input
Compound intake & SMILES parsing
02
AI model
In silico ADMET prediction
03
AI model
Organoid panel screening
04
AI model
Mechanistic pathway analysis
05
Output
Regulatory-grade dossier output
Time to Results

12–16 weeks

Compressing what used to take years of animal studies into a fraction of the timeline.

Get started

Ready to leave animal testing behind?

Speak with our scientists. Get an assessment of your compound against our NAM platform.