The global obesity epidemic is growing and the competition to develop effective and convenient weight loss treatments is heating up. Recently injectable GLP-1 receptor agonists like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound have been the stars of the show, delivering impressive weight loss for patients. But the next big thing in obesity treatment is oral meds that can do the same without the injection.
In comes Pfizer’s danuglipron, an oral GLP-1 receptor agonist. As one of the world’s largest pharmaceutical companies, Pfizer’s entry into the obesity market with an oral med could change the game for weight loss treatments. Let’s get into what danuglipron is, how it works and what it means for the future of obesity treatment.
Oral GLP-1 Agonist
GLP-1 (glucagon-like peptide-1) receptor agonists have transformed the treatment of obesity and type 2 diabetes. These drugs mimic the effects of the naturally occurring GLP-1 hormone which plays a key role in appetite and blood sugar regulation. By activating GLP-1 receptors these meds can reduce hunger, slow gastric emptying and improve insulin sensitivity leading to weight loss and better glycemic control.
While injectable GLP-1 agonists have been shown to be effective, the need for injections can be a hurdle for some patients. Oral GLP-1 agonists aim to deliver the same benefits in a pill form, potentially increasing patient adherence and expanding the market for these meds.
Danuglipron: Pfizer’s Oral Weight Loss Drug
Pfizer’s danuglipron is a small molecule GLP-1 receptor agonist to be taken once daily. The company is developing this med as part of its play in the obesity and diabetes space.
On July 11, 2024 Pfizer announced it had chosen its once-daily modified-release formulation for danuglipron and would move it into development. This followed clinical evaluations of several modified-release formulations which showed good PK data with one formulation standing out.
Mikael Dolsten, Pfizer’s Chief Scientific Officer and President of Research and Development, said danuglipron was effective in a twice-daily formulation and the once-daily formulation “will have a competitive profile in the oral GLP-1 space.”
The Road to Once-Daily Danuglipron
Pfizer’s journey to develop danuglipron hasn’t been smooth. In December 2023 the company had to stop development of the twice-daily version of danuglipron due to high discontinuation rates in the clinical trials. More than 50% of patients across all doses stopped taking the drug vs about 40% in the placebo group. The high discontinuation rates were due to AEs, 73% of patients experienced nausea, 47% vomiting and 25% diarrhea.
Before that setback Pfizer had also stopped development of another oral GLP-1 candidate called lotiglipron due to elevated liver enzymes in the clinical trials.
Despite that Pfizer continued to work on an oral obesity med. The company continued the pharmacokinetic study of the once-daily version of danuglipron and that’s now shown good results.
The Status of Danuglipron
The ongoing pharmacokinetic study is evaluating the PK and safety of immediate- and modified-release oral danuglipron in healthy adults 18 or older. So far the study has shown a PK profile that supports once-daily dosing and a safety profile consistent with previous danuglipron studies. And most importantly no liver enzymes elevation in patients, which was a concern from previous studies.
Pfizer will do dose optimization studies in H2 2024 with multiple doses of the preferred modified-release formulation. Those studies will inform the design of registration-enabling studies which are required for approval.
The news of the once-daily formulation was met with positive reaction from the market, Pfizer’s stock went up more than 3% in morning trading on the day of the announcement.
The Competition
While Pfizer is making progress with danuglipron, the company is not alone in the oral GLP-1 agonist space. Other pharma and biotech companies are also working on oral weight loss meds:
- Novo Nordisk: The current leader in injectable GLP-1 agonists is developing an oral version of semaglutide (the active ingredient in Wegovy) for weight loss. They’ve shown positive phase 3a trial results, similar to the injected version. Novo is also developing another oral weight loss pill called amycretin which has shown early promising results.
- Eli Lilly: Lilly’s oral GLP-1 agonist, orforglipron, has shown positive results in phase 2 trials. They’ve already started phase 3 trials in India.
- Roche: Recently acquired an oral GLP-1 candidate called CT-996 through its purchase of Carmot Therapeutics. Early-stage trial data has shown significant weight loss after 4 weeks of treatment.
- Viking Therapeutics: This biotech has reported positive topline results from a phase 1 study of its oral candidate VK2735 which targets both GLP-1 and GIP receptors.
- AstraZeneca: Re-entered the obesity drug space by licensing an oral GLP-1 drug called ECC5004 from Eccogene. Preliminary results have shown a “differentiating clinical profile” with good tolerability and weight reduction.
The Future of Danuglipron and Oral Obesity Meds
While Pfizer still has a long way to go before they can bring danuglipron to market, the once-daily formulation is a big step forward. They will need to do large scale clinical trials to get the data on safety, efficacy and tolerability before they can submit any regulatory applications.
Pfizer CEO Albert Bourla has said danuglipron is about 2 years behind Lilly’s oral candidate but 2 years ahead of AstraZeneca’s program. That means while Pfizer may not be the first to market with an oral GLP-1 agonist for weight loss, they could still be well positioned to grab a big share of this growing market.
The impact of oral GLP-1 agonists on the obesity space is big. These meds could offer several advantages over injectables:
- Convenience: Once-daily pills are easier for many patients to fit into their daily routine vs weekly injections.
- Reduced stigma: Some patients may feel more comfortable taking a pill vs giving themselves injections.
- Easier manufacturing and distribution: Pills are generally easier to make and distribute than injectables which could help alleviate some of the supply chain issues
- Potential for lower costs: While pricing strategies remain to be seen, oral medications are often less expensive to produce than injectables, which could lead to more affordable treatment options.
Medtep’s Role: Potential Involvement
As the landscape of obesity changes, digital health companies like Medtep could help patients get to and stick to new treatments like danuglipron. Medtep, with its personalized digital health solutions, could recommend danuglipron to patients once approved.
Medtep’s platform, which helps patients manage chronic conditions through personalized care plans and remote monitoring, could be a great tool for patients on danuglipron or other oral GLP-1’s. They could:
- Add danuglipron to treatment plans for obesity and type 2 diabetes patients.
- Send medication reminders and tracking tools to help patients stick to once daily dosing.
- Monitor for side effects and efficacy, alert HCPs when necessary.
- Collect real world data on danuglipron’s effectiveness and patient experience, for post-market surveillance and research.
- Provide educational resources to help patients understand how danuglipron works and what to expect during treatment.
By working with pharma companies like Pfizer, Medtep can help patients get full support when using new obesity treatments like danuglipron, and better outcomes and patient satisfaction.
Summary
As Pfizer moves forward with danuglipron, the future of obesity looks good. Oral GLP-1’s could open up access to these powerful weight loss medications to millions more people.
There are still challenges to overcome (clinical trials, regulatory approvals) but the progress from Pfizer and others suggests we’ll have oral options for obesity soon. When we do, companies like Medtep will help patients figure out their options and get the best results.
The obesity landscape is changing fast and danuglipron is just one of many exciting things on the horizon. As research continues and new treatments emerge we’ll have effective, convenient and personalized obesity treatments for all who need them.
FAQ: Danuglipron and Oral GLP-1 Agonists for Weight Loss
What is danuglipron?
Danuglipron is an oral GLP-1 receptor agonist being developed by Pfizer for obesity and potentially type 2 diabetes.
How does danuglipron work?
Like other GLP-1 receptor agonists, danuglipron mimics the effects of the naturally occurring GLP-1 hormone which helps regulate appetite and blood sugar levels. It reduces hunger, slows gastric emptying and improves insulin sensitivity.
How is danuglipron different from existing weight loss medications?
Danuglipron is being developed as an oral medication whereas many current GLP-1 agonists for weight loss are injectable. This could make it more convenient for patients to use.
When will danuglipron be available?
Danuglipron is still in clinical development. Pfizer needs to complete large scale clinical trials before seeking regulatory approval. It’ll be several years before it could potentially reach the market.
Are there any side effects associated with danuglipron?
In earlier studies of a twice daily formulation, common side effects were nausea, vomiting and diarrhea. The once daily formulation being developed now may have a different side effect profile which will be evaluated in future clinical trials.
How effective is danuglipron for weight loss?
Detailed efficacy data for the current once daily formulation has not been released. Future clinical trials will provide more information on its effectiveness for weight loss.
Will danuglipron be suitable for everyone with obesity?
As with all medications, danuglipron may not be suitable for everyone. Its safety and efficacy in different patient populations will be evaluated in clinical trials. Once approved, HCPs will determine if it’s appropriate for individual patients.
How might companies like Medtep be involved with danuglipron?
Digital health companies like Medtep could potentially add danuglipron to their personalized care plans, provide support for medication adherence, monitor side effects and efficacy and collect real world data on the medication’s performance.
Will oral GLP-1 agonists like danuglipron replace injectable versions?
It’s unlikely oral GLP-1 agonists will replace injectable versions. Both will coexist and offer patients and HCPs more options for personalized treatment approaches.
How might the availability of oral GLP-1 agonists impact the obesity treatment landscape?
Oral GLP-1 agonists could make these effective weight loss treatments available to a broader population including those who are reluctant to use injectable medications. This could have a big impact on obesity rates and related health outcomes if the medications prove to be safe and effective long term.