NIH-funded research U01 cooperative agreement

Human liver chip to predict drug-related liver injury

Official title: DDT-IST-000016-LOI-2 A Human Liver-Chip for Prediction of Drug-Induced Liver Injury proposed for context of use claim for the prediction of DILI within preclinical drug development program

Funded at Emulate, INC. · NIH-11181634 · Data updated 2026-11-12

This project uses a tiny engineered human liver model to help predict which new medicines might harm the liver for people taking them.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionEmulate, INC.
NIH-funded
Lab location1 site (Boston, United States)
Project startSeptember 1, 2024
Project endAugust 31, 2026
Funding year2025
Award (this year)$242,984
NIH project number5U01FD008415-02
Project IDNIH-11181634 on NIH RePORTER

Who could benefit from this research

Could help

This project does not enroll patients in a clinical trial but relies on donated human liver cells or tissue samples, so the relevant 'participants' would be consented tissue donors or collaborators supplying human liver material.

Less likely to help

People who need immediate treatment for active liver failure are unlikely to get direct benefit from this preclinical testing tool.

What this research studies

You should know researchers are building a small human liver model on a microchip that contains the liver's main cell types to mimic how a real liver works. They expose candidate medicines to the Liver-Chip and watch for signs of damage in the human cells, comparing those results to drugs known to be toxic or safe. The work aims to make preclinical testing more like what happens in real people, which is especially important when a new drug is similar to an older one that caused liver problems. The team previously showed strong ability to spot liver-toxic drugs in tests of 18 medicines and is seeking formal regulatory acceptance for this approach.

Why it matters

Potential benefit: If successful, this could lower the chance that drugs that harm the liver reach clinical trials or the market, reducing patient risk of drug-induced liver injury.

How similar studies have gone: Related organ-chip work has shown promising results—in an earlier test this Liver-Chip predicted drug-induced liver injury with about 87% sensitivity and 100% specificity across 18 drugs—though broader validation is still needed.

Where this research is happening

  • Emulate, INC.
    Boston, United States
    Active

Researchers

  • Principal investigator: Ewart, Lorna — Emulate, INC.
  • Study coordinator: Ewart, Lorna

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.