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What Are IND-Enabling Studies and Why Are They Critical to Drug Development?

Before a new drug candidate can be tested in humans, it must undergo a series of rigorous nonclinical studies to demonstrate its safety and potential efficacy. These studies are known as IND-enabling studies—a vital step in the drug development pipeline that supports a company’s Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).

At InfinixBio, we specialize in conducting IND-enabling studies that are essential for moving promising therapies from the bench to the bedside.

What Are IND-Enabling Studies?

IND-enabling studies comprise a comprehensive set of preclinical experiments designed to assess the pharmacology, toxicology, and safety profile of a drug candidate. These include:

• Pharmacokinetics (PK) – How the drug is absorbed, distributed, metabolized, and excreted.
• Pharmacodynamics (PD) – The biological effects of the drug and its mechanism of action.
• Toxicology studies – Short and long-term assessments in relevant animal models to identify potential adverse effects.
• In vitro ADME – Absorption, distribution, metabolism, and excretion studies using cell-based assays.
• Safety pharmacology – Evaluating potential impacts on vital systems (cardiovascular, respiratory, CNS).
• Bioanalytical method development and validation – Ensuring accurate measurement of drug concentrations in biological samples.

Together, these studies build the foundation for a successful IND submission.

Why Are IND-Enabling Studies So Important?

IND-enabling studies serve two critical functions:

1. Protecting Human Participants

Before any drug enters clinical trials, it must demonstrate a safety margin in animal models. This ensures that human volunteers are not exposed to unnecessary risk during First-in-Human (FIH) trials.

2. Securing Regulatory Approval

The FDA requires a well-documented and scientifically justified IND application. IND-enabling studies supply the data that regulators need to authorize human clinical trials.

Without this preclinical groundwork, drug developers risk delays, clinical holds, or outright rejection—setting back years of innovation and investment.

How InfinixBio Supports IND-Enabling Programs

InfinixBio provides a comprehensive suite of preclinical services tailored to meet  regulatory expectations and accelerate time to IND. Our integrated approach combines:

• Study design consulting from experienced pharmacologists and toxicologists
• GLP-compliant laboratory testing for reproducible, audit-ready data
• Customized PK/PD and bioanalytical methods to match the unique properties of your compound
• Cross-functional collaboration with your clinical and regulatory teams to streamline the transition to Phase 1

Whether you’re developing a small molecule, biologic, or medical countermeasure, our  team ensures your IND-enabling studies are precise, predictive, and aligned with your program goals.

Ready to Advance Your Drug Candidate?

If you’re planning an IND submission or exploring strategic CRO partnerships, InfinixBio is here to help. Contact us today to learn how our scientific expertise and regulatory insight can de-risk your path to the clinic.