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Regulations & Compliance

Clinical trial phases

The staged process of testing a new drug in humans: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale confirmation), and Phase 4 (post-marketing surveillance). Each phase has specific objectives and requirements.

Frequently Asked Questions

What is Clinical trial phases?
The staged process of testing a new drug in humans: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale confirmation), and Phase 4 (post-marketing surveillance). Each phase has specific objectives and requirements.
Why is Clinical trial phases important in peptide research?
Understanding clinical trial phases is crucial for navigating the legal and regulatory landscape of peptide use. Regulatory knowledge helps practitioners and patients distinguish between approved therapies, compounded medications, and research chemicals.

Related Terms

Phase 1 trial

The first stage of human clinical testing, focused on safety, tolerability, pharmacokinetics, and dose-ranging in 20–100 healthy volunteers. Determines the maximum tolerated dose.

Phase 2 trial

The clinical trial stage that evaluates efficacy, optimal dosing, and side effects in 100–300 patients with the target condition. Phase 2 results determine whether to proceed to large Phase 3 trials.

Phase 3 trial

Large-scale randomized controlled trials (1,000–3,000+ patients) comparing the investigational peptide to placebo or standard of care. Positive Phase 3 results are required for FDA approval.

IND (investigational new drug)

An application submitted to the FDA before human clinical trials can begin. The IND includes preclinical data, manufacturing information, and the proposed clinical trial protocol.

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