Home Diabetes Care The Danuglipron Pill Could Be the Next Ozempic

The Danuglipron Pill Could Be the Next Ozempic

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The Danuglipron Pill Could Be the Next Ozempic

This content originally appeared here. Republished with permission.

A brand new once-a-day pill in development could also be just as powerful because the injectable medication Ozempic for type 2 diabetes and obesity, in line with a phase two clinical trial. And it may fit even faster.

Though Novo Nordisk’s injectable diabetes drug semaglutide (Ozempic) has taken the world by storm, one other pharmaceutical giant, Pfizer, is developing its own drug in the identical family of GLP-1 receptor agonists.

Learn More About GLP-1 Receptor Agonists at Diabetes Each day

Its name is danuglipron, and it’s arguably essentially the most user-friendly formulation yet. It could possibly be a blockbuster.

The brand new drug passed a significant hurdle this week when the outcomes of its most important trial so far were published within the medical journal JAMA Network Open. This early look suggests that danuglipron is just as secure and powerful as other drugs within the GLP-1 family, including Ozempic.

It is going to likely be a number of years before danuglipron may be approved and sold in the USA, but some experts are already declaring that the brand new drug shall be a game changer that may earn billions of dollars annually, per an article published in Fierce Pharma. There could possibly be tens of millions of adults with type 2 diabetes or obesity which might be desirous to try a GLP-1 receptor agonist, but would like to not inject themselves, and would strongly prefer an easy-to-use every day pill. Pfizer stock prices immediately jumped after the outcomes were published.

How Well Does Danuglipron Treat Type 2 Diabetes?

The experiment tested danuglipron in 411 adults with type 2 diabetes. Most participants took metformin, and all had an A1c between 7 and 10.5 percent, which the study defined as “inadequately controlled.” (A1c is a measurement of average blood sugar levels.) The American Diabetes Association recommends most adults with diabetes to focus on an A1c of lower than 7 percent.

At the very best dosage level, danuglipron users experienced the next metabolic advantages:

  • A1c dropped by 1.16 percentage points
  • Fasting plasma glucose dropped by 33 miligrams per deciliter (mg/dL)
  • Weight dropped by 4.17 kilograms (kg), or 9.2 kilos (lbs)

Remarkably, these results took place over only 16 weeks.

How does that compare with Ozempic? The first pivotal trial of subcutaneous semaglutide, the treatment that may eventually be named Ozempic, delivered barely more impressive results: an A1c drop of 1.55 percentage points and weight reduction of 4.53 kg (9.99 lbs) in an identical population. But this trial lasted 30 weeks, not 16, making it an apples-to-oranges comparison. (A subsequent trial also established that a bigger dose of Ozempic over an extended time period was even more practical).

Danuglipron Versus Rybelsus for Diabetes and Weight Loss

There’s already an oral type of semaglutide, a every day pill with the brand name Rybelsus. While Rybelsus appears to be just as powerful as Ozempic, ounce for ounce, it has a notable drawback. Rybelsus is something of a hassle to take — it should be swallowed on an empty stomach exactly half-hour before eating or drinking anything apart from water, and before using another oral medications. Danuglipron may be taken with or without food, and due to this fact could also be a more user-friendly therapy.

Danuglipron appears to be no less powerful than Rybelsus, though the published results require some interpretation.

Within the PIONEER 2 trial, six months of the very best dose of Rybelsus helped individuals with type 2 diabetes drop their A1c drop 1.3 percentage points. After one 12 months, study participants had lost about 10 lbs. Those numbers are roughly comparable with the outcomes that danuglipron achieved in just 4 months, but there stays a possibility that danuglipron users would have enjoyed even greater weight reduction or glycemic improvement in the event that they had continued to take the drug for six to 12 months.

Novo Nordisk may soon ask the FDA for approval of larger doses of Rybelsus, which a recent study has shown results in more impressive metabolic improvements.

Danuglipron May Have Side Effects

If there’s bad news, it’s that danuglipron’s unwanted effects look like considerable. At the very best dosage, participants reported the next effects, amongst others:

  • 32 percent of users reported nausea
  • 25 percent reported vomiting
  • 10 percent reported diarrhea

Nearly half of all participants reported a minimum of one episode of gastrointestinal disorder, and 34 percent discontinued the study medication due to a “treatment-emergent hostile event.”

While these numbers look concerning, they aren’t necessarily surprising. Other GLP-1 receptor agonists, especially the blockbuster semaglutide, are related to similar gastrointestinal effects, per Diabetes Each day. Some Ozempic users have even begun to experiment with custom doses to alleviate their suffering, Diabetes Each day notes.

And other people have already shown that they’re willing to tolerate a high prevalence of those uncomfortable effects, given the magnitude of the health advantages and weight reduction. The utmost-strength dosage of semaglutide available, for instance, has substantially higher rates of gastrointestinal unwanted effects than danuglipron: Based on a trial published within the The Latest England Journal of Medicine, 44 and 32 percent of users report nausea and diarrhea, respectively.

For now, it seems that danuglipron may cause the next rate of unwanted effects than Rybelsus. The JAMA Network Open study suggests that a more gradual dose escalation schedule could help improve danuglipron’s tolerability, even though it may also decelerate the noteworthy speed with which it appears to deliver its positive results.

The drug appears to be otherwise secure.

When Will Danuglipron Be Approved?

Danuglipron still has its biggest tests ahead: phase three clinical trials, which can subject the drug to its most comprehensive evaluations yet. These trials last a 12 months or longer and might enroll 1000’s of participants as a way to learn as much as possible concerning the drug’s long-term safety and efficacy.

If danuglipron has surprisingly good or bad cardiovascular effects, as discussed in a recent study, for instance, it could propel the drug to the forefront of treatment — or scuttle Pfizer’s plans for it entirely.

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