Understand the source comparison
Peptide Clinical Trials Phases: Comparison Table
Preclinical Safety & mechanism in animals Animal models, in-vitro 3–6 years ~5–10% file IND Foundation. Poor preclinical data guarantees Phase I failure Phase I Safety & pharmacokinetics 20–80 healthy volunteers or patients 12–18 months ~70% advance High pass
No winner is assigned.
This page preserves a source comparison for education. It does not add a rating, recommendation or clinical judgment.
- Preclinical
- Safety & mechanism in animals
- Animal models, in-vitro
- 3–6 years
- ~5–10% file IND
- Foundation. Poor preclinical data guarantees Phase I failure
- Phase I
- Safety & pharmacokinetics
- 20–80 healthy volunteers or patients
- 12–18 months
- ~70% advance
- High pass rate. But only pre-screened candidates reach this stage
- Phase II
- Efficacy & dose-ranging
- 100–300 patients with target condition
- 2–3 years
- ~30–40% advance
- Highest failure rate. Lack of efficacy kills most peptides here
- Phase III
- Large-scale efficacy & safety
- 1,000–3,000+ patients, multicentre
- 3–5 years
- ~50–60% advance
- Expensive. $100M–$300M typical cost, no refunds for failures
- FDA Review
- Regulatory approval decision
- Data submission, not patients
- 10–24 months
- ~85% approved if filed
- Filing an NDA signals confidence. Most rejections are manufacturing issues
- Phase IV
- Post-market surveillance
- Real-world patient populations
- Ongoing after approval
- N/A
- Rare adverse events, long-term outcomes, and new indication exploration