A brief history of oral peptides
a day ago
- #FDA
- #drug-delivery
- #peptides
- Semaglutide is a peptide that the stomach is designed to destroy, making oral delivery challenging.
- Historically, oral peptide drugs like insulin have had very low bioavailability (below 1-2%).
- Novo Nordisk achieved a breakthrough with SNAC, a molecule that enhances semaglutide absorption to 0.8% bioavailability.
- SNAC works by buffering stomach pH, preventing peptide clumping, and temporarily altering gastric cell membranes.
- Other permeation enhancers like C10 and C8 have been tried but with limited success and high costs.
- Hims marketed an oral semaglutide pill with unproven absorption technology, lacking clinical trials or published data.
- The FDA referred Hims to the DOJ, leading to the withdrawal of their oral semaglutide product.
- The tension between regulatory oversight and medical innovation is highlighted, with some gray areas benefiting patients.
- The system prioritizes evidence-based treatments, but gaps and delays in regulation can create opportunities for exploitation.