The U.S. regulatory system is preparing for a possible review of a new GLP-1 drug that, according to Reuters, could receive a decision before the end of the year.
If that happens, a global launch could follow in 2026.
The pace is unusual, but not surprising in a market where soaring demand for weight-loss medication has created bottlenecks and drawn political attention in several countries.
At the center is orforglipron, a daily pill developed by Novo Nordisk and Eli Lilly.
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NDTV reports that the companies are working in parallel on documentation and scale-up in order to meet anticipated international demand.
Kenneth Custer, an executive at Eli Lilly, has emphasized the company’s desire for rapid progress in regulatory processes.
He stated that positive trial data had made it possible to move forward with global submissions.
Clinical results in the background
Early trials show that participants in one study achieved weight loss exceeding the results seen with Ozempic.
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According to NDTV’s review, this has been linked to the potential advantage that a tablet form may make it easier for patients to adhere to treatment.
Interest in the drug stems from the fact that existing GLP-1-based medications are primarily administered as injections.
NDTV notes that the developers aim to offer an alternative that can be used without equipment or storage requirements.
Several experts point out that such solutions could lower barriers for new patient groups.
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According to information cited from the medical platform 1mg, orforglipron is considered a potential tool for both people with type 2 diabetes and individuals with severe obesity.
This is partly because daily tablets often result in stronger treatment adherence.
Risks and limitations
However, the medication may come with side effects.
Harvard Health reports that nausea, diarrhea, vomiting, and digestive discomfort resemble the patterns seen with existing GLP-1 treatments.
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This suggests that the drug does not differ significantly in its risk profile.
Orforglipron could potentially change the availability of non-invasive weight-loss treatments, but its impact will depend on approval, production capacity, and long-term evidence.
Sources: NDTV, Reuters, Harvard Health og 1mg.