Interest in peptides and peptide drugs has dramatically increased in recent months. On July 23rd and 24th, the FDA intends to consult PCAC regarding the potential inclusion of various peptides, specifically BPC-157, Emideltide (DSIP), Epitalon, KPV, MOTs-C, Semax, and Thymosin Beta-4 fragment (TB-500), on the 503A bulks list. To prepare for patient questions and to increase understanding in advance of the meeting, a review of available information on safety and efficacy is essential. This blog post is the first in a series that will review available information on peptide drugs up for evaluation in July.
Body protective compound (BPC-157) is a pentadecapeptide (15 amino acids in length) that was originally derived from a much larger molecule isolated from human gastric juice. Though many potential benefits associated with BPC-157 have been proposed, including reduction of inflammation (including management of inflammatory conditions such as ulcerative colitis), the main indications are thought to be related to wound healing and regeneration.1 BPC-157 is typically administered via the oral or injectable (intramuscular, intraarticular, or intravenous) route and has been studied both ways for its utility for wound healing. Notably, specific estimates of bioavailability via the oral route are currently unavailable. BPC-157 has a short half-life of approximately 30 minutes and is metabolized by the liver.5
The benefit of BPC-157 for wound healing is thought to be related to its ability to enhance fibroblast activity, stimulate collagen synthesis, and upregulate skeletal muscle protein synthesis. BPC-157 is also thought to have an anti-inflammatory effect.2 Studies in rats and in vitro data with human cells suggest that BPC-157 may also increase expression of vascular endothelial growth factor receptor 2 (VEGFR2) and therefore may contribute to angiogenesis and associated wound healing.3
Much of the current data is in animal trials, however, BPC-157 has been studied in a limited capacity in humans as well. One study evaluated the impact of BPC-157 intra-articular injection on patients with knee pain of various causes, including ligamentous and tendinous sprains. The study was small, with 12 patients receiving BPC-157 injections and four receiving combination BPC-157 and thymosin-beta 4 (TB4) injections. Of the 12 patients on BPC-157 alone, 11 reported improvement. Of the four receiving combination therapy, three reported improvement. The studied doses were 4mg BPC-157 (2mg/mL with a 2mL injected volume) or 1-4mg BPC-157 (in 1-2mL) combined with 3-6mg (1-2mL) of TB4. Benefit was evaluated at 3 months, 3-6 months, and 6 month to 1 year windows, with most patients reporting benefit later in the 6 month to 1 year window. No adverse events were noted to be associated with therapy in this small study.4
Studies on BPC-157 in humans via the oral, intramuscular, subcutaneous, or intravenous routes are not currently available. Studies in rats for injury have looked at 10ng/kg up to 10mcg/kg both orally and via injection.6 The human equivalent dose of 10mcg/kg in rats per FDA provided calculations would be 1.89mcg/kg, corresponding to approximately 110 – 130mcg doses in a 60 to 70kg human.7 Though appropriate dosing for humans remains unclear given the lack of studies, animal data suggests a very favorable safety profile, with studies unable to report the acute lethal or toxic dose via the intramuscular, intraperitoneal, intravenous, or oral routes in animal trials in rats or dogs looking at dosing from 6mcg/kg all the way up to 20mg/kg over a 6 week period.5 BPC-157 has also been studied in a limited capacity topically in animals, with one study on burn wounds evaluating the effect of BPC-157 in a cream at 1mcg/g. The study found the BPC-157 treatment to be superior to placebo treatment and treatment with silver sulfadiazine.6
Looking for more about BPC-157 and other peptides up for evaluation in 2026 and 2027? FACTS members can check out our Peptide Review Sheet, available on www.fagronacademy.us. If you’re interested in listening in on the PCAC meeting, more information can be found here: July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee - 07/23/2026 | FDA
Highlights:
Amino Acid Sequence:1 Gly Glu Pro Pro Pro Gly Lys Pro Ala Asp Asp Ala Gly Leu Val (15 amino acids)
Potential Uses:2,3 There is interest around the potential use of this peptide for wound healing, especially in the context of sports injury including muscle or ligament tears and bone healing. There is also data in animals to support its use for gastrointestinal ulceration or inflammatory bowel disease.
Regulatory Notes:5 BPC-157 is up for evaluation for potential inclusion on the 503A Bulks List. The material is set to be evaluated in July 2026. It is currently banned by various sport regulatory authorities, including the World Anti-Doping Agency (WADA), the Ultimate Fighting Championship (UFC), and the National Football League (NFL).
The topics and descriptions discussed within this review are not intended and should not be interpreted to make recommendations or claims regarding the use, efficacy, or safety of products, formulas, or vehicles. Only a physician or other appropriately licensed professional, as a learned intermediary, can determine if a formula, product or service is appropriate for a patient. Furthermore, this review is not intended and should not be interpreted to make recommendations or claims regarding the legality of compounding any specific preparation using any substance covered in this review. Compounders should understand federal and state legal and regulatory requirements before handling these substances. Consultation with experienced legal counsel is recommended.
References:
1. Chang CH, Tsai WC, Hsu YH, Pang JH. Pentadecapeptide BPC 157 enhances the growth hormone receptor expression in tendon fibroblasts. Molecules. 2014;19(11):19066-19077. Published 2014 Nov 19. doi:10.3390/molecules191119066
2. DeFoor, Mikalyn T Dekker, Travis J et al. Injectable therapeutic peptides – an adjunct to regenerative medicine and sports performance?. Arthriscopy. 2025. 41(2): 150-152.
3. Hsieh, MJ., Liu, HT., Wang, CN. et al. Therapeutic potential of pro-angiogenic BPC157 is associated with VEGFR2 activation and up-regulation. J Mol Med 95, 323–333 (2017). https://doi.org/10.1007/s00109-016-1488-y
4. Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. Alternative Therapies. 2021; 27(4): 8-13.
5. Vasireddi N, Hahamyan H, Salata MJ, et al. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS J. Published online July 31, 2025. doi:10.1177/15563316251355551
6. Seiwerth S, Milavic M, Vukojevic J, Gojkovic S, Krezic I, Vuletic LB, Pavlov KH, Petrovic A, Sikiric S, Vranes H, Prtoric A, Zizek H, Durasin T, Dobric I, Staresinic M, Strbe S, Knezevic M, Sola M, Kokot A, Sever M, Lovric E, Skrtic A, Blagaic AB and Sikiric P (2021) Stable Gastric Pentadecapeptide BPC 157 and Wound Healing. Front. Pharmacol. 12:627533. doi: 10.3389/fphar.2021.627533
7. Nair AB, Jacob S. A simple practice guide for dose conversion between animals and human. J Basic Clin Pharm. 2016;7(2):27-31. doi:10.4103/0976-0105.177703
