Future path3 min read
Organs-on-chips
Organs-on-chips (tissue chips) are engineered microsystems that mimic the structure and function of the heart, kidneys, lungs and other organ systems. They are a research tool for developing drugs and predicting whether drugs will be safe or toxic in humans — not a treatment given to patients.
According to the NCATS, the early users of these chips are laboratory scientists in universities, the pharmaceutical industry and regulatory bodies, and the FDA is exploring how they can be used to assess drug safety. In April 2025 the FDA announced a plan to phase out the animal testing requirement for monoclonal antibodies and other drugs, in which it mentioned human organoids grown in the laboratory and organ-on-a-chip systems.
The NCATS says non-animal alternatives need further improvement to replace animal testing entirely, and the FDA aims to speed up validation and adoption of these methods, with updates to guidance rolled out in stages.
- In widespread clinical use
- Approved for specific uses
- In clinical trials
- Preclinical
- Concept
A laboratory research tool for drug development and safety assessment, not a treatment; and the FDA is working on validating and adopting them as an alternative to some animal testing.
- Predicting drug safety or toxicity in humansPreclinical
Research use at the drug development stage.1
- Reducing reliance on animal testing in drug development
A plan announced by the FDA in April 2025, with updates to its guidance rolled out in stages.3
Status last checked: · What the maturity levels mean
What is this path?
Also called "organs-on-chips", they mimic the structure and function of the heart, kidneys, lungs and other systems.
Tissue chips are engineered micro-systems that represent units of human organs.
Where does the research stand?
They are used to predict whether drugs are safe or toxic in humans.
The main early users are laboratory scientists in universities, the pharmaceutical industry and regulatory bodies, and the FDA is exploring how they can be used to assess drug safety.
In April 2025 the FDA announced a plan to phase out the animal testing requirement for monoclonal antibodies and other drugs, which mentions human organoids grown in the laboratory and organ-on-a-chip systems.
What separates it from clinical use?
It is a research tool used by scientists in laboratories, industry and regulatory bodies, not a treatment for patients.
Non-animal alternatives need further improvement to replace animal testing entirely.
The FDA aims to speed up validation and adoption of these methods, with updates to guidance rolled out in stages.
Common questions
Questions for your doctor
- What is the evidence for the safety and effectiveness of the new drug proposed for me?
- Is the proposed drug approved for my condition, or is it still in trials?
References
- 1NCATS (NIH). Tissue Chip for Drug Screening. ncats.nih.gov/research/research-activities/tissue-chipHealth agencies & guidelines · Accessed 2026-10-08
- 2NCATS (NIH). Tissue Chip Frequently Asked Questions. ncats.nih.gov/research/research-activities/tissue-chip/faqHealth agencies & guidelines · Accessed 2026-10-08
- 3U.S. FDA. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugsHealth agencies & guidelines · Accessed 2026-10-08
Review status: Edited content · Last updated:
Change log
- — Page created.
Educational content only — no diagnosis, and no substitute for a clinician.