Future GLP-1 Therapies Could Be Here Sooner, Thanks to This Change from the FDA

Original posted at obesity.news/ on Dec 04, 2025

Today the FDA confirmed that it plans to make one clinical trial the new default for drug approval. For years the rule has been two large pivotal studies. In practice the agency has already been flexible, but this is the first time the FDA is formally saying that one trial will usually be enough.

There will still be cases where two trials are required. There will still be safety follow up and strict review. But the starting point just moved.

Some critics will say this lowers the bar. And in some categories that might be a fair debate. But for people like us who are watching the obesity space, this is not a story about cutting corners. The GLP-1 and broader incretin class has already been run through enormous programs. Semaglutide alone has been studied in more than 40,000 people across the SUSTAIN diabetes program, the PIONEER oral program, the STEP obesity trials and the SELECT heart outcomes trial. And this is to say nothing of the millions of people who have been tracked in post marketing data. We are not guessing anymore. We know how these medicines work. We know the side effect profile. We know the cardiomeabolic benefits. We know the long term impact.

What this change really means is time. Time removed from the development cycle. Time companies no longer have to spend duplicating massive trials. Time that gets shaved off the wait for the next generation after Zepbound and Wegovy. And time ticking away faster on the duopoly of Lilly and Novo.

If one pivotal trial becomes the norm, smaller companies can afford to finish programs that would have died under the old rules. Oral incretins can move faster. Amylin combos can move faster. Muscle targeted drugs can move faster. And once there are more real competitors in the market, the downward price pressure intensifies.

Faster approvals mean the cost of existing drugs will keep trending down. Lower costs mean expanded coverage. Expanded coverage means more people treated for a disease that new standards show could effect up to 7 in 10 adult Americans.

We will have a lot to talk about tomorrow on our new On The Pen Live show, which airs every Monday, Wednesday and Friday on YouTube.

Hope to see you there!

Stay tuned to OnThePen.com for more updates and in depth analysis on the latest developments in weight loss and diabetes treatments. Sharing this article is a powerful form of advocacy that brings us closer to our goal of educating the masses and reducing the stigma of obesity. If you found this article insightful, please share it within your networks, especially in Facebook groups and Reddit forums dedicated to GLP-1 medications and diabetes management. Together, we can make a difference.

This article is reader-supported on Substack.

To receive new posts and support my work,

consider becoming a free or paid subscriber.

Subscribe