Comment from Clarianne Jimenez
AnonymousSupportAcademic
Summary: Dr. Clarianne I. Jimenez, an academic researcher and educator, argues that the committee should not permanently foreclose Semax from the 503A Bulk Drug Substances List due to insufficient evidence. Instead, she proposes a defined research pathway to address safety and efficacy concerns, citing substantial mechanistic and gene-expression data as a scientific rationale for further investigation.
I respectfully submit the attached public comment concerning Semax, under consideration for the Section 503A Bulk Drug Substances List at the July 23 to 24, 2026 Pharmacy Compounding Advisory Committee meeting. I write in an individual academic capacity as a researcher and educator. This comment does not assert that Semax is proven safe and effective, and it does not request inclusion on the strength of the current record. It openly acknowledges the identified abuse-liability signal, which I agree must be resolved through a dedicated study before any favorable determination, and it asks the Committee to weigh the substantial mechanistic and gene-expression evidence as a coherent scientific rationale warranting a defined research pathway rather than permanent foreclosure. This comment is offered in the interest of a complete scientific record and not on behalf of any nominator or commercial party.