What is Danuglipron? Is it Ozempic in a pill?

As the use of medications like Ozempic and Wegovy for diabetes and weight loss soars, a new player in the field, danuglipron, might change the game once again. From drug shortages to pricing, the inconvenience hasn’t quelled the demand for these life-changing medications, and the newcomer, a twice-daily pill currently being developed by drugmaker Pfizer, could add a new level of convenience for those averse to injections required with many of the other options. And the best part? It may be even more effective than Ozempic and Wegovy when it comes to weight loss and blood sugar control.

Danuglipron is one of several new drugs jostling into the growing market for weight loss drugs. While still under investigation and not yet FDA-approved, this pill is already showing promising results when it comes to managing type 2 diabetes by managing blood sugar and body weight.

This might sound a lot like existing drugs used for the same purpose, like Ozempic and Wegovy—but danuglipron is not the same drug, and instead of being taken with a small injection like Ozempic and Wegovy, danuglipron is a pill taken twice a day.

A phase two clinical trial of danuglipron showed favorable weight and blood sugar control and suggested it may be able to do so even faster than the drugs currently on the market with a similar safety profile.

Biochemically speaking, danuglipron is similar to the injectable medication semaglutide (the generic name for brand-name medications Ozempic and Wegovy). These drugs all fall under a class of medications known as glucagon-like peptide 1 receptor agonists (or GLP-1s for short). But unlike some of the other drugs available, danuglipron is a small molecule GLP-1, which is part of why it can be taken by mouth, rather than with a subcutaneous injection like Ozempic and Wegovy.

Like with similar drugs, studies investigating the use of danuglipron involve gradual increases in subjects’ dosages to achieve a balance between blood sugar control and weight management while reducing the likelihood of side effects.

While it may be some time before danuglipron is FDA-approved and available for prescription use, there’s ample evidence that the drug will help people lose weight: more than 9 lbs on average over the course of 16 weeks. Researchers haven’t yet directly studied danuglipron in comparison with the already approved drugs available, but a broad comparison of existing research suggests that danuglipron offers comparable results in a shorter amount of time than injected semaglutide.

To illustrate: a 30-week trial of Ozempic called SUSTAIN 1 resulted in participants losing 4.53 kg (just shy of 10 lbs) and reducing their hemoglobin A1C (a measure of a person’s average blood sugar levels over recent months) by 1.55 percentage points. A follow-up trial looking at a higher dose given over 40 weeks called SUSTAIN FORTE saw even greater improvements. However, during the danuglipron trial, over the course of just 16 weeks, participants taking the highest dosage experienced an average weight loss of 4.17 kg and a drop in hemoglobin A1C levels of 1.16 percentage points offering comparable results in about half the time.

Just like the other GLP-1 receptor agonists, Danuglipron helps people to lose weight in much the way that injectable semaglutide can: by mimicking the action of the hormone GLP-1. These drugs all work by mimicking the effects of GLP-1, a naturally occurring hormone in our bodies. GLP-1 is usually released after we eat and has a range of effects, including suppressing our appetite by delaying gastric emptying (how long it takes for food to leave your stomach and continue along the digestive tract), reducing blood sugar, and stimulating the release of insulin. These effects are what help people lose weight.

Danuglipron isn’t the first GLP-1 receptor agonist designed to be taken by mouth. Rybelsus is the first oral GLP-1. This once-daily pill contains the same active ingredient as Ozempic: semaglutide. It’s also already FDA-approved for the treatment of type 2 diabetes.

And while Rybelsus is already available, studies show that it may be less effective than danuglipron when it comes to weight loss. Clinical trials of Rybelsus showed that participants taking the highest possible dose (14 mg) lost an average of just over 10 lbs over the course of a year. While impressive (and a useful option for people who prefer an oral medication) this dose of Rybelsus is pharmacologically equivalent to the lowest dose of Ozempic, 0.5 mg in terms of how effective it is for weight loss. That potentially makes it a less helpful option for people that need a more potent dosage for blood sugar control or weight management. 

Danuglipron, on the other hand, appears to achieve comparable metabolic benefits of weight loss and glycemic control in less than half the time. Phase two clinical trials of danuglipron demonstrated levels of glycemic control and weight loss in 16 weeks that it took study participants a year to achieve with Rybelsus.

In terms of side effects, danuglipron and Rybelsus appear to cause similar issues—namely, gastrointestinal discomfort. For both, the most commonly reported side effects are nausea, vomiting, and diarrhea.  Danuglipron does seem to cause higher levels of these side effects, however; in a large trial, the most common side effect for Rybelsus, nausea, never exceeded 10%, but for danuglipron, as many as 33% experienced nausea. However, similar side effects are common in this class of drug; as many as 44% of people experience nausea when taking a high dose of injectable semaglutide.

Another key difference between danuglipron and Rybelsus is how user-friendly they are. While both are taken by mouth, Rybelsus has more restrictions on when and how it can be taken. Rybelsus must be taken with a small amount of water 30 minutes before you eat, drink, or take any other medications. Danuglipron can be taken with or without food.

It bears repeating that, while results may be promising, danuglipron isn’t yet approved by the FDA and it may be some time before the drug is available.

The main side effects of danuglipron seen in studies include the same gastrointestinal upset seen with other GLP-1 receptor agonists already on the market. These side effects include: 

• Nausea

• Vomiting

• Diarrhea

Studies have shown that side effects are mostly mild and tend to improve with continued use.

Roughly a third of study participants using danuglipron reported nausea and about a quarter of them reported vomiting. As with similar drugs, side effects were more common among people taking higher doses of the drug, and those whose doses were escalated faster.

Although a few people did experience excessively low blood sugar (hypoglycemia) while using the medication, there were no cases of severe hypoglycemia seen in the study. There were also no cases of pancreatitis, which (while rare) has been noted to be a risk with injected semaglutide.

Danuglipron is still under development, so it’s a long way from being approved by the Food and Drug Administration for use as a diabetes medication or weight loss drug. Later-stage clinical trials will typically involve additional research in order to refine dosing and dose-increase schedules, as well as to understand the longer-term safety of the drug.

The substantial interest in these medications has fueled a wealth of research into GLP-1 receptor agonists, providing the medical community with ever more data surrounding the safety and efficacy of this type of drug.

Once danuglipron is approved by the FDA for use, it will likely quickly become one of the most popular options on the market, thanks to the ease of administration as a pill rather than a shot.

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Current version

July 05, 2023

Written by

Nancy LaChance, BSN, RN

Fact checked by

Yael Cooperman, MD

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About the medical reviewer

Yael Cooperman, MD, Ro

Yael Cooperman is a physician and works as a Senior Manager, Medical Content & Education at Ro.