BPC-157: [Preclinical vs Human] Safety Data Comparison
Rat tendon injury model 10 μg/kg daily 14 days None observed High-quality controlled trial Proof-of-concept only. Not translatable to human dosing Rat gastric ulcer model 10 μg/kg–10 mg/kg 7–14 days Randomised, histology-verified endpoints Demonstrates low acu
This comparison does not assign a generated winner or score.
- Rat tendon injury model
- 10 μg/kg daily
- 14 days
- None observed
- High-quality controlled trial
- Proof-of-concept only. Not translatable to human dosing
- Rat gastric ulcer model
- 10 μg/kg–10 mg/kg
- 7–14 days
- Randomised, histology-verified endpoints
- Demonstrates low acute toxicity but insufficient for chronic safety
- Mouse inflammatory bowel disease model
- Well-controlled, mechanism-focused
- Mechanistic insight but no human safety relevance
- Human pilot trial (gastric ulcer)
- Not disclosed
- 4 weeks
- 'No adverse effects reported'
- Poor disclosure. No safety protocol described
- Insufficient for regulatory safety assessment
- Human pilot trial (tendon injury)
- Not reported
- Case series. No control group
- Anecdotal; not considered evidence in regulatory review
- Formal Phase I human safety study
- N/A
- Does not exist
- Required for IND application. Absent for BPC-157