BPC-157

Peptide Data Sheet for Pharmacists and Compounding Professionals

BASIC INFORMATION

Name: BPC-157 (Body Protection Compound-157)
Class: Synthetic pentadecapeptide
Structure: 15-amino acid partial sequence of Body Protection Compound (BPC)
Molecular Weight: 1419.53 g/mol
Sequence: Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val
Chemical Modifications: None; direct partial sequence of body protection compound

Available Forms:

  • Research peptide
  • Compounded formulations (subject to regulatory requirements)
  • Not available as an FDA-approved medication

REGULATORY STATUS

FDA Status

  • Not FDA-approved for any medical condition
  • Classified as a research compound
  • FDA has clarified it is among peptides unlawful to use in making compounded medications
  • Included on FDA’s list of bulk drug substances that present significant safety risks

Legal Considerations

  • Not approved for human use or consumption
  • Often marketed “for research purposes only”
  • Compounding pharmacies should be aware that FDA has specifically identified BPC-157 as a substance that should not be used in compounding

MECHANISM OF ACTION

The precise mechanism of action remains under investigation, but research suggests BPC-157:

  • Promotes angiogenesis (formation of new blood vessels)
  • Accelerates the formation of granulation tissue
  • Increases expression of growth hormone receptors
  • Interacts with nitric oxide (NO) system
  • May influence dopamine and serotonin systems
  • Promotes tendon, ligament, and bone healing through:
    • Enhanced fibroblast migration
    • Increased type I collagen synthesis
    • Activation of the FAK-paxillin pathway
Mechanism of Action

PHARMACOKINETICS

| Parameter | Value | Notes | |———–|——-|——-| | Absorption | Variable based on administration route | Limited human data | | Distribution | Unknown | Primarily studied in animal models | | Metabolism | Likely proteolytic degradation | Specific pathways not well characterized | | Elimination | Unknown | Half-life not well established in humans |

Note: Pharmacokinetic data is primarily derived from animal studies; human data is extremely limited.

POTENTIAL APPLICATIONS (INVESTIGATIONAL)

Note: All applications are investigational and not FDA-approved. This information is provided for educational purposes only.

Gastrointestinal

  • Inflammatory bowel disease
  • Gastric ulcers
  • Intestinal anastomosis healing
  • Esophagogastric anastomosis

Musculoskeletal

  • Tendon and ligament healing
  • Muscle injury recovery
  • Joint inflammation
  • Bone healing

Neurological

  • Peripheral nerve injury
  • Traumatic brain injury
  • Spinal cord injury

Other Investigational Areas

  • Wound healing
  • Corneal injury
  • Periodontal tissue regeneration
  • Cardioprotection

ADMINISTRATION (INVESTIGATIONAL)

Routes

  • Subcutaneous injection
  • Intramuscular injection
  • Oral (stability issues, likely poor bioavailability)
  • Topical (limited data on effectiveness)

Investigational Dosing

Note: No established safe or effective dosing regimen exists. The following information is based on research protocols and is not a recommendation for clinical use.

| Route | Investigational Dose Range | Frequency | |——-|—————————-|———–| | Subcutaneous | 250-500 mcg | Once or twice daily | | Intramuscular | 250-500 mcg | Once or twice daily | | Oral | 500-1000 mcg | Once or twice daily |

SAFETY PROFILE

Reported Adverse Effects

Note: Safety data is extremely limited and primarily from anecdotal reports and animal studies.

  • Nausea
  • Gastrointestinal discomfort
  • Dizziness
  • Injection site reactions
  • Fatigue
  • Headache

Potential Risks and Concerns

  • Unknown long-term effects
  • Potential for growth promotion in pre-existing cancers
  • Lack of quality control in commercially available products
  • Potential for contamination in non-pharmaceutical grade products
  • Unknown drug interactions
  • Unpredictable biological effects

Contraindications (Theoretical)

  • Active malignancy
  • Pregnancy and lactation
  • Children and adolescents
  • Autoimmune conditions
  • Bleeding disorders
  • Prior to surgical procedures

SPECIAL POPULATIONS

Pregnancy and Lactation

  • No human data available
  • Avoid use due to unknown risks

Pediatric

  • No human data available
  • Not recommended for use in pediatric populations

Geriatric

  • No specific data available
  • Potentially higher risk of adverse effects

PHARMACIST GUIDANCE

Compounding Considerations

  • FDA has clarified that BPC-157 is among peptides unlawful to use in making compounded medications
  • Pharmacists should be aware of regulatory restrictions
  • If compounding is legally permitted in specific circumstances:
    • Requires aseptic technique and sterile compounding environment
    • Stability affected by temperature and mechanical agitation
    • Adhere to USP <797> standards for sterile compounding

Storage and Handling (Research Settings)

  • Store lyophilized peptide at -20°C
  • Reconstituted solutions typically stored at 2-8°C
  • Use within 2-4 weeks of reconstitution
  • Avoid repeated freeze-thaw cycles
  • Protect from light

Patient Counseling Points

  • Not FDA-approved for any indication
  • Limited safety and efficacy data in humans
  • Unknown long-term effects
  • Potential for serious adverse effects
  • Importance of discussing all supplements and medications with healthcare providers
  • FDA has warned against its use in compounded medications

ETHICAL AND PROFESSIONAL CONSIDERATIONS

For Pharmacists

  • Be aware of FDA position on BPC-157 in compounding
  • Understand legal and ethical implications of dispensing non-FDA approved peptides
  • Maintain professional standards when discussing investigational compounds
  • Provide evidence-based information when consulted about BPC-157
  • Consider liability issues related to non-FDA approved compounds

For Researchers

  • Ensure proper informed consent in research settings
  • Follow institutional and regulatory guidelines for research peptides
  • Document and report adverse events
  • Maintain scientific integrity in research protocols

REFERENCES

  1. FDA. Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  2. Chang CH, et al. Gastroprotective potential of pentadecapeptide BPC 157 against experimental gastric ulcers in rats. J Pharmacol Sci. 2011;115(4):547-55.
  3. Seiwerth S, et al. BPC 157 and standard angiogenic growth factors. Gastrointestinal tract healing, lessons from tendon, ligament, muscle and bone healing. Curr Pharm Des. 2018;24(18):1972-1989.
  4. Sikiric P, et al. Stable gastric pentadecapeptide BPC 157: novel therapy in gastrointestinal tract. Curr Pharm Des. 2011;17(16):1612-32.
  5. Gwyer D, et al. Gastric pentadecapeptide body protection compound BPC 157 and its role in accelerating musculoskeletal soft tissue healing. Cell Tissue Res. 2019;377(2):153-159.