Novo Nordisk seeks FDA approval of a 25 mg Ozempic tablet for type 2 diabetes
A higher-dose oral version of semaglutide is under FDA review for type 2 diabetes, which could add another pill option for people who use or are considering GLP-1 treatment.
Novo Nordisk is waiting on an FDA decision for a 25 mg tablet version of Ozempic (semaglutide) for adults with type 2 diabetes, according to a GLP-1 pipeline update published in August 2026 [1]. The company filed a supplemental application for the new strength, and a decision is expected in 2026 [1]. The oral Ozempic strengths available today top out at 9 mg [1].
The 25 mg tablet would be a new strength of a medicine that is already on the market, not a new drug. A supplemental application is the route companies use to add a strength, a new use or other changes to an already approved product [1]. The filing covers adults with type 2 diabetes, the same condition the current oral strengths are cleared for [1].
The August 2026 pipeline update is one in a series that Prime Therapeutics publishes to track GLP-1 medications moving through FDA review [1]. It lists the 25 mg Ozempic tablet among the GLP-1 products awaiting an agency decision in 2026 [1].
Several details have not been disclosed. The update does not give a month or a specific date for the decision [1]. It does not state a price for the 25 mg tablet, whether health plans would cover it, or where it would sit on formularies [1]. It also does not say how the 25 mg strength compares with lower strengths in blood sugar control or side effects, and no advisory committee meeting has been reported [1].
Why it matters for patients
Semaglutide is sold under several brand names, and the tablet form is a different product from the weekly injections. For people with type 2 diabetes who prefer not to inject, oral options are the main alternative, and the range of oral strengths is one factor in how treatment is adjusted over time [1].
A 25 mg tablet would represent a substantially higher oral dose than the 9 mg maximum now available if the FDA approves it [1]. That does not mean everyone on a lower oral dose would move up. Whether a higher strength helps depends on the individual, and decisions about which strength to use are made by prescribers, not by what the FDA approves [1].
Approval would not automatically make the product easy to get. Coverage rules, prior authorization requirements and out-of-pocket costs are set by insurers and pharmacy benefit managers, and none of that has been described in the filing [1]. People taking an oral semaglutide now would keep their current prescription unless a prescriber changes it [1].
It is also not yet known whether Novo Nordisk plans to seek approval of the 25 mg tablet for any use beyond type 2 diabetes [1].
What happens next
The FDA is expected to decide on the supplemental application at some point in 2026 [1]. No specific date, and no date for an advisory committee review, has been reported [1]. If the agency approves the 25 mg tablet, when it would reach pharmacies and what it would cost have not been disclosed [1].
Sources
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