Tag: Regulatory status

Developed in Russia, the synthetic peptide Selank has been used clinically for years for Generalized Anxiety Disorder, but its safety profile and legal status remain complex outside of Eastern Europe. **How safe is Selank?** While numerous studies point to a non-toxic profile and low risk of addiction, its non-FDA-approved status in the U.S. raises important considerations for potential users.

Developed in Russia in the 1980s, Semax is a peptide drug used for various neurological conditions in Eastern Europe [1.3.2, 1.5.2]. For many in the West, the primary question is: **Is Semax FDA approved** for use in the United States?

According to the U.S. Food and Drug Administration (FDA), BPC-157 is an unapproved drug that presents "significant safety risks," with no legal basis for human consumption. Therefore, discussing how many times a week should I take BPC 157 is misleading, as its use is not clinically supported or deemed safe for humans outside of controlled research settings.

In 2011, the pharmaceutical company Takeda voluntarily withdrew its serrapeptase product in Japan after postmarketing trials found it ineffective for its approved uses [1.7.3, 1.6.1]. This event casts a long shadow over the question: is serrapeptase banned in Europe?