BPC-157 Safety Profile — Clinical Evidence & Research Summary

Preclinical Research Summary

Key Preclinical Studies

Study	Model	Key Findings	Ref
He et al. (2022)	SD rats / Beagle dogs	PK study: IV t½ = 15.2 min (rats), 5.27 min (dogs); bioavailability 14-19% (rats IM), 45-51% (dogs IM); distributed to kidney, liver, stomach	[26]
Xu et al. (2020)	Mice, rats, rabbits, dogs	Multi-species toxicity: no LD1 achieved, no adverse signs at 20 mg/kg (rats) or 10 mg/kg (dogs)	[9]
Staresinic et al. (2003)	Rats — Achilles transection	10 µg/kg IP: improved AFI scores, increased load-to-failure at 14-72 days; reversed corticosteroid impairment	[17]
Tudor et al. (2010)	Mice — TBI	10 µg/kg IP: reduced brain edema, hemorrhage, and mortality; improved conscious/unconscious/death ratio	[19]
Perovic et al. (2019)	Rats — spinal cord	200 µg/kg IP: axonal recovery maintained to 1 year; counteracted necrosis, demyelination, cyst formation	[20]
Vukojevic et al. (2020)	Rats — bilateral carotid occlusion	Upregulated Egr1/Akt1/Src/Vegfr2/Nos3; downregulated Nos2/Nfkb in hippocampus	[14]
Hsieh et al. (2017/2020)	Rat hind limb ischemia + CAM	129–152% increased angiogenesis; VEGFR2-Akt-eNOS pathway confirmed	[7]
Sever et al. (2019)	Rats — bile duct ligation	Reversed liver fibrosis, cirrhosis, and portal hypertension; normalized enzymes/bilirubin	[23]
Matek et al. (2025)	Rats — quadriceps detachment	Oral BPC-157 in drinking water: full muscle-to-bone reattachment at 90 days; annihilated leg contracture	[18]
Chang et al. (2011/2014)	Rat tendon fibroblasts (in vitro)	↑ GHR expression, activated FAK-paxillin pathway, enhanced cell survival and migration	[12][13]

Clinical / Human Studies

Study	Design	n=	Key Outcome	Ref
Phase II Ulcerative Colitis	Multicenter RCT, double-blind, placebo-controlled	53	80 mg enema daily × 2 wks: significant DAI decrease vs placebo; very well-tolerated, no AEs vs placebo	[6]
Phase I PK/Safety	Single-blind, placebo-controlled	32	Rectal 0.25-2 mg/kg: very low systemic absorption; well-tolerated, no safety differences vs placebo	[27]
Knee Pain Retrospective	Chart review	16	2 mg intra-articular: 91.6% significant improvement lasting 6 months–1 year; no adverse effects	[24]
Interstitial Cystitis Pilot	Pilot study	12	10 mg intravesical: 83.3% complete resolution, remaining 2 subjects reported 80% improvement; no AEs	[25]
IV Safety Pilot	Pilot study	2	10-20 mg IV: no adverse effects on cardiac, hepatic, renal, or thyroid biomarkers	[28]

Pharmacokinetic Parameters

Parameter	Value	Ref
IV Half-life (rats)	15.2 minutes	[26]
IV Half-life (dogs)	5.27 minutes	[26]
Bioavailability IM (rats)	14–19%	[26]
Bioavailability IM (dogs)	45–51%	[26]
T_max (rats)	~3 minutes	[26]
Major Metabolite	Proline (amino acid)	[26]
Gastric Stability	>24 hours in human gastric juice	[3]
Urine Detection	4–5 days via LC-MS	[26]
Lethal Dose	Not achieved (>2 g/kg IV/IG in mice)	[9]

The products offered on this website are furnished for in-vitro studies only. In-vitro studies (Latin: in glass) are performed outside of the body. These products are not medicines or drugs and have not been approved by the FDA to prevent, treat or cure any medical condition, ailment or disease. Bodily introduction of any kind into humans or animals is strictly forbidden by law.

For Laboratory Research Only. Not for human use, medical use, diagnostic use, or veterinary use.

ALL ARTICLES AND PRODUCT INFORMATION PROVIDED ON THIS WEBSITE ARE FOR INFORMATIONAL AND EDUCATIONAL PURPOSES ONLY.

Preclinical Research Summary

Key Preclinical Studies

Study	Model	Key Findings	Ref
He et al. (2022)	SD rats / Beagle dogs	PK study: IV t½ = 15.2 min (rats), 5.27 min (dogs); bioavailability 14-19% (rats IM), 45-51% (dogs IM); distributed to kidney, liver, stomach	[26]
Xu et al. (2020)	Mice, rats, rabbits, dogs	Multi-species toxicity: no LD1 achieved, no adverse signs at 20 mg/kg (rats) or 10 mg/kg (dogs)	[9]
Staresinic et al. (2003)	Rats — Achilles transection	10 µg/kg IP: improved AFI scores, increased load-to-failure at 14-72 days; reversed corticosteroid impairment	[17]
Tudor et al. (2010)	Mice — TBI	10 µg/kg IP: reduced brain edema, hemorrhage, and mortality; improved conscious/unconscious/death ratio	[19]
Perovic et al. (2019)	Rats — spinal cord	200 µg/kg IP: axonal recovery maintained to 1 year; counteracted necrosis, demyelination, cyst formation	[20]
Vukojevic et al. (2020)	Rats — bilateral carotid occlusion	Upregulated Egr1/Akt1/Src/Vegfr2/Nos3; downregulated Nos2/Nfkb in hippocampus	[14]
Hsieh et al. (2017/2020)	Rat hind limb ischemia + CAM	129–152% increased angiogenesis; VEGFR2-Akt-eNOS pathway confirmed	[7]
Sever et al. (2019)	Rats — bile duct ligation	Reversed liver fibrosis, cirrhosis, and portal hypertension; normalized enzymes/bilirubin	[23]
Matek et al. (2025)	Rats — quadriceps detachment	Oral BPC-157 in drinking water: full muscle-to-bone reattachment at 90 days; annihilated leg contracture	[18]
Chang et al. (2011/2014)	Rat tendon fibroblasts (in vitro)	↑ GHR expression, activated FAK-paxillin pathway, enhanced cell survival and migration	[12][13]

Clinical / Human Studies

Study	Design	n=	Key Outcome	Ref
Phase II Ulcerative Colitis	Multicenter RCT, double-blind, placebo-controlled	53	80 mg enema daily × 2 wks: significant DAI decrease vs placebo; very well-tolerated, no AEs vs placebo	[6]
Phase I PK/Safety	Single-blind, placebo-controlled	32	Rectal 0.25-2 mg/kg: very low systemic absorption; well-tolerated, no safety differences vs placebo	[27]
Knee Pain Retrospective	Chart review	16	2 mg intra-articular: 91.6% significant improvement lasting 6 months–1 year; no adverse effects	[24]
Interstitial Cystitis Pilot	Pilot study	12	10 mg intravesical: 83.3% complete resolution, remaining 2 subjects reported 80% improvement; no AEs	[25]
IV Safety Pilot	Pilot study	2	10-20 mg IV: no adverse effects on cardiac, hepatic, renal, or thyroid biomarkers	[28]

Pharmacokinetic Parameters

Parameter	Value	Ref
IV Half-life (rats)	15.2 minutes	[26]
IV Half-life (dogs)	5.27 minutes	[26]
Bioavailability IM (rats)	14–19%	[26]
Bioavailability IM (dogs)	45–51%	[26]
T_max (rats)	~3 minutes	[26]
Major Metabolite	Proline (amino acid)	[26]
Gastric Stability	>24 hours in human gastric juice	[3]
Urine Detection	4–5 days via LC-MS	[26]
Lethal Dose	Not achieved (>2 g/kg IV/IG in mice)	[9]

For Laboratory Research Only. Not for human use, medical use, diagnostic use, or veterinary use.

ALL ARTICLES AND PRODUCT INFORMATION PROVIDED ON THIS WEBSITE ARE FOR INFORMATIONAL AND EDUCATIONAL PURPOSES ONLY.

Product Index

BPC-157: Safety Profile & Research Summary

Preclinical Research Summary

Key Preclinical Studies

Clinical / Human Studies

Pharmacokinetic Parameters

References

Related Research Questions

BPC-157: Safety Profile & Research Summary

Preclinical Research Summary

Key Preclinical Studies

Clinical / Human Studies

Pharmacokinetic Parameters

References

Related Research Questions