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BREAKING: Novo Nordisk Has Filed for Approval for High Dose Oral Semaglutide

Breaking news today as Novo Nordisk has aknowledged that they have applied for FDA approval for a high dose version of their oral Semaglutide, marketed for diabetes under the brand name Rybelsus.


The race to deliver a viable oral option for obesity treatment is officially on. Eli Lilly and Novo Nordisk are the two major players bringing powerful GLP-1 medications to the table. But while they’re both aiming to capture the same market, the way they’re going about it couldn’t be more different. Lilly’s orforglipron and Novo’s oral semaglutide each offer something distinct, and depending on who you are and what you need, one might end up being a better fit.


Let’s break down how they compare across four areas that matter most: weight loss results, manufacturing and access, regulatory status, and who they’re being tested on.



Weight Loss: How Do They Stack Up?

  • Orforglipron helped people with type 2 diabetes lose up to 7.9 percent of their body weight in just 40 weeks. That’s no small feat, especially considering that people with diabetes often lose less weight than those without. It also dropped A1C levels by as much as 1.6 points, making it a solid dual-threat for those managing both blood sugar and body weight.

  • High Dose Oral semaglutide, on the other hand, delivered some jaw-dropping results. In the OASIS 1 trial, patients taking 50mg daily lost an average of 15.1 percent of their body weight over 68 weeks. Nearly 85 percent of participants lost at least 5 percent of their starting weight. That kind of consistency across a large trial makes a real statement.


For now, Novo’s oral semaglutide seems to have the edge on raw weight loss, but orforglipron is still in the game and could prove even stronger in populations without diabetes. More on that below.



Manufacturing and Access: Small Molecule vs Peptide

  • Orforglipron is a small molecule drug, not a peptide. That means it’s easier and cheaper to make. It doesn’t need cold storage, which simplifies distribution. For patients, that could mean more consistent access and lower prices down the road.

  • Oral semaglutide is a peptide, which means it’s more complex to produce. It also uses a special absorption enhancer to get through the stomach. Production is already stretched thin because of demand for injectable semaglutide drugs like Wegovy and Ozempic, and that’s slowed down expansion plans for the pill version.


The takeaway here is simple. Even if oral semaglutide gets approved first, Lilly may be able to get orforglipron to more people faster, just because it’s easier to make and distribute.



FDA Status: Who’s Closer to the Finish Line?

  • Novo Nordisk confirmed today that they have already submitted oral semaglutide to the FDA for use in obesity. It’s currently approved as Rybelsus for type 2 diabetes, but this would expand its use and marketing to those who don’t have diabetes but need help with weight loss. If approved, it would be the first oral GLP-1 drug specifically indicated for obesity.

  • Eli Lilly is still in Phase 3 trials for orforglipron in people without diabetes. Those results are expected in mid 2025, and FDA submission should follow soon after. It’s not as far along as oral semaglutide, but Lilly has prioritized this project and is moving quickly.



Who’s Being Studied?

  • Oral semaglutide has been tested in people with obesity or who are overweight and have at least one health issue like high blood pressure or high cholesterol. This is the kind of trial population that matches the real world.

  • Orforglipron, so far, has only been successfully tested in people with type 2 diabetes. That data is still incredibly useful, but the big test will come in July of this year when results are published for non-diabetic participants. That’s when we’ll really see what this drug can do for the broader obesity population.



What This Means for Patients

Both of these oral GLP-1 drugs are bringing something huge to the table. Oral semaglutide has proven weight loss results and is further along in the approval process. Orforglipron has the advantage of being simpler to make, store, and ship, which could solve some of the access issues that have plagued current treatments.


In the end, this isn’t a fight where only one drug wins. The real winners will be the patients, especially those who can’t or won’t use injectables. And that’s exactly what this moment calls for more options, more access, and more momentum in the fight against obesity.


Stay tuned to On The Pen for updates as both of these pills move closer to becoming real-world options for millions of Americans who need them.

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