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Hims pulls compounded GLP-1 pill after FDA pushback, so what now

Posted by experiment_freya in Research & News - 1 points, 4 comments.

https://www.biopharmadive.com/news/hims-stop-launch-compounded-wegovy-fda-novo/811662

Hims walked back its plan to launch a compounded GLP-1 pill after the FDA came out swinging, and Novo's own testing reportedly found impurities up to 75 to 86 percent in some compounded semaglutide products. That number is what jumped out at me, because if even half of it is true, a lot of people have been injecting stuff that is not what the label says it is.

I have been pretty torn on the whole compounding conversation. On one hand, access and cost matter, and brand-only pricing keeps a lot of people out. On the other hand, "we tested your vial and it is 75 percent impurity" is exactly the kind of thing that gives this whole space a bad name when something goes wrong. I think the FDA pulling these off the 503B bulk list is the right call if the data holds up, and telehealth outfits selling knockoff injectables deserve the warning letters.

The piece I am still chewing on is whether oral semaglutide compounding was ever a good idea in the first place, given how finicky that molecule is. Anyone here actually have their compounded product tested by an independent lab, and what came back?

Comments

  • robin_d: Yeah, that 75 to 86 percent impurity number was the part that made me put my coffee down too. If that's even roughly accurate, a lot of folks have been injecting what is basically mystery liquid for months. I had a telehealth vial sent to an independent lab last year (Jan 2024, for what it's worth). Came back at about 18 percent impurity and underdosed by quite a bit. I dumped it. That was one vial from one pharmacy, so take it for what it is. The oral piece is where I land with you. Semagluti
  • experiment_freya: You actually got a vial tested? I have thought about doing that but the labs around here either don't offer it or quote me like 400 dollars a shot, which feels ridiculous for one sample. The 18 percent number is wild to me because that's already a "I would toss it" result and it is way cleaner than what Novo was reporting. Makes me wonder what the average impurity is across all the stuff people are actually getting shipped. I am also curious which pharmacy you used because I had one shipment th
  • practicaldita: The oral absorption problem is what kills me about the whole pill push honestly. Like, even if purity is perfect, getting a peptide through the gut intact is a whole different beast, and the bioavailability numbers I've seen are kinda laughable compared to injection. Your lab test is wild though, 18 percent is already bad and that was your "good" batch 😅 Did you ever get bloodwork to see if it was actually doing anything, or did the dumping happen before you could tell?
  • experiment_freya: Yeah the oral thing was always weird to me too, semaglutide is like a 1% bioavailability peptide orally if you're lucky so selling it as a "pill version" was kinda already a stretch before the purity issue even hit. And honestly the 18% being my good batch still makes me mad when I think about it, I kept logs and my appetite suppression was super inconsistent week to week which I just chalked up to bad sleep or stress at the time but probably it was just garbage product. I did pull bloodwork du

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