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What is the new name for BPC 157?: Addressing regulatory changes and alternatives

5 min read

In late 2023, the U.S. Food and Drug Administration (FDA) classified BPC-157 as a bulk drug presenting significant safety risks, effectively prohibiting its use in compounded medications. For many users, this regulatory action led to a significant question: What is the new name for BPC 157?

Quick Summary

This article addresses the nomenclature and current regulatory status of the synthetic peptide BPC-157, explaining how recent FDA and WADA actions have restricted its availability. It also examines alternatives like Pentadeca arginate (PDA) that have emerged in the market.

Key Points

  • No New Brand Name: The experimental peptide BPC-157 has not been officially re-branded with a new name by a pharmaceutical company following regulatory actions.

  • FDA Compounding Ban: The FDA classified BPC-157 in late 2023 as a bulk drug presenting significant safety risks, prohibiting its use in compounded medications due to lack of human safety data.

  • WADA Prohibition: BPC-157 was added to the World Anti-Doping Agency's (WADA) Prohibited List in 2022 under the 'S0 Unapproved Substances' category.

  • Rise of Alternatives: In response to regulatory restrictions, alternative compounds like Pentadeca arginate (PDA) are being promoted, though their regulatory status and safety for human use are also unproven.

  • Limited Human Data: Most evidence regarding BPC-157's effects comes from animal studies, with robust human clinical data on its safety and efficacy being almost non-existent.

  • Theoretical Cancer Risk: Due to its ability to promote angiogenesis (new blood vessel growth), BPC-157 carries a theoretical risk of supporting the growth of pre-existing tumors, though this is not definitively proven in humans.

  • Unregulated Product Dangers: Purchasing BPC-157 as a 'research chemical' carries significant risks, including product impurities, contamination, and undefined dosages due to lack of regulation.

In This Article

The question of a "new name" for BPC-157 stems from recent regulatory crackdowns by federal authorities, not a simple re-branding effort by a manufacturer. BPC-157 was never an FDA-approved drug, but was widely available via compounding pharmacies and through the online sale of "research chemicals". The FDA's action in late 2023 targeted this legal gray area, significantly impacting access to the peptide for human use. In response to this market gap, some alternative substances, such as Pentadeca arginate (PDA), have been promoted as replacements, further fueling confusion.

What are the original and alternative names for BPC-157?

BPC-157, which stands for Body Protection Compound 157, was never officially a drug with a single brand name. It is a synthetic pentadecapeptide, meaning it consists of 15 amino acids. It is based on a segment of a naturally occurring protein found in human gastric juice. Historically, it has been referred to by several other names in research and unofficial circles, including:

  • Body Protection Compound 157
  • Gastric Pentadecapeptide BPC-157
  • PL 14736
  • Bepecin
  • Colloquially, the "Wolverine" peptide due to its promoted healing properties

There is no single "new name" that BPC-157 has legally adopted. Instead, its unavailability has led some to seek similar-acting, but distinct, alternatives. One such emerging compound is Pentadeca arginate (PDA), which is being marketed as an "almost identical" peptide but with an added arginate salt for stability. The legal and safety status of these alternatives often follows a similar unapproved path, carrying the same risks.

The FDA and WADA restrictions on BPC-157

Federal regulatory bodies have taken a firm stance against BPC-157 for human use, citing a significant lack of robust human clinical data regarding its safety and efficacy.

FDA's compounding ban

In September 2023, the FDA's decision to list BPC-157 as a Category 2 bulk drug effectively barred compounding pharmacies from using it in medications. The reasons provided by the FDA for this action include:

  • Significant safety risks: The agency expressed concern about potential immune reactions, peptide impurities, and undefined long-term effects due to the absence of sufficient safety information.
  • Lack of clinical data: The FDA has not identified enough human clinical data to know whether the drug would cause harm when administered to humans.
  • API characterization complexities: Concerns were raised regarding inconsistencies in the active pharmaceutical ingredient (API) characterization and peptide impurities.

WADA's prohibition

The World Anti-Doping Agency (WADA) also prohibits BPC-157. In 2022, WADA added the peptide to its Prohibited List under the S0 Unapproved Substances category. This means that athletes cannot use BPC-157 for any purpose during or out of competition, and there is no basis for a Therapeutic Use Exemption (TUE).

The shift to alternatives and associated risks

Following the regulatory restrictions on BPC-157, some market players have begun offering alternative peptides. Pentadeca arginate (PDA) is one such compound, marketed as a more stable version with a similar amino acid sequence. However, it is crucial for consumers to understand that these alternatives face similar regulatory and safety concerns.

Comparison: BPC-157 vs. Pentadeca Arginate (PDA)

Feature BPC-157 Pentadeca Arginate (PDA)
Chemical Name Gastric Pentadecapeptide BPC-157 Pentadeca Arginate
Amino Acid Structure 15 amino acids (Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val) Similar 15 amino acid sequence with an added Arginate salt
Regulatory Status (USA) Unapproved drug; compounding prohibited by FDA (Category 2) Unapproved drug; not evaluated by FDA
WADA Status Prohibited (S0 Unapproved Substances) Likely prohibited under S0 Unapproved Substances
Human Clinical Data Sparse, low-quality, and often conflicting Essentially non-existent
Mechanism of Action Promotes angiogenesis, modulates growth factors, anti-inflammatory Claims similar actions to BPC-157
Primary Risk Factors Lack of human safety data, potential impurities, theoretical tumor progression Lack of human safety data, potential impurities, theoretical tumor progression, unproven claims

Unproven claims and ethical considerations

The online community and some wellness clinics have long promoted BPC-157 based on promising animal studies, with anecdotal reports suggesting benefits for gut health, joint pain, and faster injury recovery. However, the crucial distinction between animal research and proven human efficacy and safety is often blurred. The lack of rigorous, large-scale, independent human clinical trials means that these benefits are unproven and potential risks are not fully understood.

One significant theoretical concern highlighted by researchers is BPC-157's effect on angiogenesis. While beneficial for healing by improving blood supply to damaged tissues, this same mechanism could theoretically support the growth of existing tumors. Although no definitive link between BPC-157 and cancer has been established in humans, the unknown risk profile, combined with the lack of published human safety data, is a major red flag for regulatory bodies and cautious clinicians.

The dangers of purchasing "research chemicals"

With legal avenues for obtaining BPC-157 largely closed, many turn to websites selling it as a "research chemical." These products are explicitly labeled "not for human use," and their sale is unregulated. This practice poses serious risks to consumers:

  1. Purity and Contamination: There is no oversight to ensure the purity of the active peptide. Products may contain impurities, incorrect dosages, or other unknown substances.
  2. Sterility: For injectable products, the lack of sterile manufacturing processes can lead to serious infections.
  3. No Safe Dosage: Without clinical trials, a safe or effective dosage for humans has not been determined.

Conclusion: A landscape of uncertainty and risk

To answer the question, "What is the new name for BPC 157?" requires understanding that the peptide itself has no new, officially sanctioned name for medical use. Instead, its unavailability has led to the rise of unregulated alternatives like Pentadeca arginate (PDA). BPC-157 has been deemed too risky for human use by major regulatory bodies, including the FDA and WADA, due to insufficient human safety data and unproven efficacy. Anyone considering the use of BPC-157 or its unapproved alternatives should be aware of the inherent risks associated with unregulated products and consult with a qualified healthcare professional. The promising results from animal studies do not translate into guaranteed safety for humans, and proceeding without proper oversight and clinical evidence is a hazardous gamble. For more information, visit the U.S. Anti-Doping Agency's page on prohibited substances.

Frequently Asked Questions

There is no FDA-approved replacement for BPC-157. While some unapproved peptides like Pentadeca arginate (PDA) are marketed as alternatives, they also lack robust human safety and efficacy data, posing similar risks.

In late 2023, the FDA classified BPC-157 as a Category 2 bulk drug with 'significant safety risks.' This regulatory action legally prohibits compounding pharmacies from using it to create compounded medications.

Based on current research, there is no proof that BPC-157 directly causes cancer. However, because it promotes angiogenesis (blood vessel growth), there is a theoretical concern that it could support the growth of pre-existing tumors, although this is unproven in humans.

No. Products sold as 'research chemicals' are not intended or approved for human use. Their safety, purity, and dosage are not guaranteed by any regulatory body, exposing users to significant and unknown risks.

BPC-157 was originally named Body Protection Compound 157 and is also known as Gastric Pentadecapeptide BPC-157, PL 14736, and Bepecin.

Animal research suggests BPC-157 can promote the healing of tendons, ligaments, and muscle tissue, improve gut health, and exhibit anti-inflammatory effects. These findings, however, have not been sufficiently validated in humans.

Commonly reported side effects, though largely anecdotal, include mild headaches, nausea, dizziness, and injection site irritation. Serious or long-term effects are not well-documented due to limited human research.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.