FDA Briefing doc for upcoming pharmacy advisory compounding committee.
Nothing surprising. No evidence that BPC does much. Not really a shocker since it's mostly a placebo effect driven by online hype and hysteria.
https://www.fda.gov/media/193343/download
Edited: Here's the cliff notes version.
It's promising if you're a rat:
- Prevention of colonic fistulas
- Protection against NSAID-induced stomach/intestinal lesions
- Hepatoprotective effects
- No dose-response relationships were established
- Molecular targets and mechanisms of action remain unknown
- Animal results don't reliably predict human outcomes
Animal Toxicity Findings (28-day studies):
- Clotting abnormalities: aPTT shortening in rats, prolongation in dogs (suggesting altered clotting)
- Liver signals: elevated ALT, glucose, and triglycerides
- No teratogenicity observed in pregnant rats
Reported Adverse Events (FAERS Database) for humans:
- Injection site reactions (redness, swelling)
- Shortness of breath requiring ER visit
- Diffuse hyperpigmentation and gingival darkening
Immunogenicity Concerns (major FDA concern):
- Immune responses ranging from benign antibodies to life-threatening reactions
- Peptide aggregation (which can trigger immune responses and reduce efficacy)
- Potential neutralization of endogenous peptides