Retatrutide is not FDA-approved for human use. Yet the experimental weight loss peptide is everywhere — TikTok, Instagram, online marketplaces. Here is what the black market craze reveals about the FDA's peptide blind spot.
Oral peptides will replace injectables for some classes — GLP-1s are leading — but not most. The economics of 1% bioavailability mean oral delivery only works for large-market, high-price peptides. For many, a once-weekly injection is more convenient than a daily fasting pill.
Between 2027 and 2030, patents on 14 peptide drugs worth $32B will expire. The GLP-1 biosimilar opportunity is immense but capital-intensive. Smart innovators are already shifting to next-generation molecules — the patent cliff is a stress test, not a crisis.