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GLP-1 drugs primed for FDA approval in 2026

With Pharma titans Eli Lilly and Novo Nordisk continuing to duke it out for control of the GLP-1 market, both are seeking FDA approval for new drugs this year.

Alivia Kaylor, MSc
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Published: 07 Jan 2026

As pharma giants Eli Lilly and Novo Nordisk continue to fight for dominance in a GLP-1 market projected to reach more than $140 billion in sales by the end of the decade, the space is expected to remain a duopoly between the two drugmakers.

Despite growing global demand for obesity and other metabolic drugs, the market is largely shaped by the manufacturing scale and commercial success of these two players until new entrants make their way into the fray.

Since the two drug companies continue to control the obesity and diabetes space, they've consequently set the tone on innovation, pricing and access. And this dynamic is unlikely to change in 2026.

At least two GLP-1 drugs are expected to go through FDA review this year, one from Eli Lilly and the other from Novo Nordisk, setting the stage for the next phase of competition between the two rivals.

The GLP-1 developmental pipeline is moving fast, offering new drug modalities for weight loss and chronic disease management. The approval of the following oral and next-generation options has the potential to increase patient choice and impact pricing dynamics in the GLP-1 drug market.

Eli Lilly's first-in-class pill, orforglipron

Eli Lilly's closely watched obesity pill, orforglipron, is expected to become the first GLP-1 therapy approved in 2026. After receiving a National Priority voucher that drastically speeds up drug reviews, the company filed for FDA approval in mid-December, with a decision expected by the end of next month.

Orforglipron differs from other oral GLP-1s available on the market, including the first to the space -- Lilly's own diabetes medication Rybelsus. It also differs from Novo Nordisk's oral version of its blockbuster weight loss drug, Wegovy, which was approved by the FDA at the end of 2025.

Unlike those, Lilly's pill is a small-molecule, non-peptide GLP-1 receptor agonist that can be taken daily without food or water restrictions. This makes orforglipron a more convenient option than Rybelsus and Wegovy, which both must be taken on an empty stomach for better absorption.

Lilly seems to be aiming for wider use of its pill, which hit its mark in a late-stage maintenance trial last month. After 72 weeks, orforglipron helped people maintain their weight loss for up to a year after switching from GLP-1 shots, like Wegovy and Lilly's Zepbound, pointing to a possible new use for the drug.

Discovered by Chugai Pharma and licensed by Lilly in 2018, orforglipron is also being developed to treat type 2 diabetes and is in its final stage of research. Eli Lilly plans to submit it to the FDA this year, the company says.

Novo Nordisk's GLP-1/amylin analogue, CagriSema

CagriSema is Novo Nordisk's next-generation bid to gain more ground in the  booming weight loss space after Eli Lilly took the lead and became the first drugmaker to hit $1 trillion in market value.

The Danish drugmakers' dual agonist, CagriSema, combines cagrilintide -- a dual amylin/calcitonin receptor agonist -- with semaglutide, the active ingredient in Novo's FDA-approved GLP-1 drugs Ozempic and Wegovy.

Although the once-weekly, injectable combination drug fell short of the company's 25% weight loss goal in its first phase 3 trial, CagriSema appears to be an improvement on Wegovy alone but fails to outperform Zepbound.

Participants in the late-phase study lost an average of 20.4% of their body weight after taking CagriSema for 68 weeks, compared to 14.9% with semaglutide, 11.5% with cagrilintide alone and 3% with placebo.

Novo has positioned CagriSema to be a potential successor to Wegovy for obesity, but if the drug is approved, it could face formulation-specific manufacturing challenges. Unlike single-main-ingredient injectables like Wegovy and Zepound, CagriSema's co-formulation can't be mixed, requiring each to be made separately and placed in a dual-chambered pen.

On Dec. 18, Novo announced it had submitted CagriSema for regulatory review as a weight management treatment. The FDA is expected to review the application this year. If approved, CagriSema would be the first to combine an injectable GLP-1 receptor agonist and an amylin analogue.

In addition to obesity, CagriSema is also being researched in adults with type 2 diabetes and other chronic conditions, such as chronic kidney disease and alcohol-related liver disease. Novo Nordisk plans to file for regulatory approval for treating diabetes in the first quarter of this year as well.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.

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