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Repair peptides

BPC-157

Body Protection Compound 157; pentadecapeptide BPC

US status
PCAC-recommended · pending
Class
Repair peptides
Approved product
None
Route
None lawful; sold as research-use-only material

Regulatory record

September 2023
FDA places BPC-157 in Category 2 of the interim 503A bulks list, citing immunogenicity risk and impurity concerns; Category 2 placement bars pharmacy compounding.
April 2026
FDA removes BPC-157 and eleven other peptides from Category 2 without adding them to Category 1; the removal ends the explicit prohibition but confers no authorization.
July 2026
The Pharmacy Compounding Advisory Committee votes 8–6 to recommend adding BPC-157 to the section 503A bulks list. The vote is advisory; FDA rulemaking is required before any pharmacy may compound it.
FDA final action
None as of August 2026.

Status verified for this index · August 2026

Definition

BPC-157 is a synthetic pentadecapeptide, a chain of fifteen amino acids corresponding to a fragment of Body Protection Compound, a protein identified in human gastric juice. It is not an approved drug in any jurisdiction, and no product containing it has completed the clinical development that an approval requires [1].

Preclinical work attributes its effects to promotion of angiogenesis and modulation of growth-factor signaling; those mechanisms are described in rodent models and have not been established in humans [1].

Evidence

PubMed indexes 228 papers mentioning BPC-157 as of August 2026; none is indexed as a clinical trial [2]. The evidence base is preclinical, resting principally on rodent models of tendon transection, ligament injury, and gastrointestinal damage [1]. Human safety data sufficient for regulatory review do not exist, which is the gap the FDA cited when it restricted the compound in 2023 [3].

The distance between commercial visibility and published evidence is unusually wide here. BPC-157 draws roughly 183,000 United States searches per month while the human trial record remains empty; a reader weighing the compound is weighing animal data.

Lawful access

In September 2023 the FDA placed BPC-157 in Category 2 of the interim bulk drug substances list, the category reserved for substances with significant safety concerns, citing immunogenicity risk and impurity questions; Category 2 placement barred licensed pharmacies from compounding it [3].

In April 2026 the agency removed BPC-157 and eleven other peptides from Category 2 without adding them to Category 1. Removal ended the explicit prohibition but conferred no authorization. In July 2026 the Pharmacy Compounding Advisory Committee voted 8–6 to recommend adding BPC-157 to the section 503A bulks list [4, 5]. The vote is advisory; the FDA has not issued a final rule, and as of August 2026 no licensed United States pharmacy may lawfully compound BPC-157.

Material sold online as BPC-157 is research-use-only chemical supply. It is produced and sold outside pharmacy licensure, prescriber oversight, and pharmaceutical quality standards; its identity, purity, and sterility are whatever the vendor says they are.

References

  1. Mateescu DM, Gavrilescu DM, Constantinescu FE, et al. BPC-157 as an investigational peptide therapeutic: biopharmaceutical challenges, formulation strategies, and translational development barriers. Pharmaceutics. 2026. PMID 42198317
  2. PubMed, National Library of Medicine. Search conducted August 2026: 228 records for "BPC 157" or "BPC-157"; zero records under the clinical-trial publication type across three name variants. Source
  3. US Food and Drug Administration. Interim policy on compounding using bulk drug substances under section 503A; Category 2 listing of BPC-157, September 2023. Source
  4. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. Source
  5. American Journal of Managed Care. FDA panel backs 6 peptides for compounding. July 2026. Source