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FDA Approves New Once-Daily GLP-1 Weight Loss Tablet (Orforglipron)

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 The FDA has approved a new once-daily GLP-1 tablet for “adults with obesity, or overweight with weight-related medical problems”. 

On 1 April 2026, Eli Lilly announced that the US Food and Drug Administration (FDA) had approved its once-daily oral weight loss medication Orforglipron, under the brand name Foundayo. 

The drug is Lilly’s second approved GLP-1 treatment, following the weight loss injection Tirzepatide, marketed as Mounjaro in the UK. 

At the time of writing, approval has only been granted in the United States. However, Eli Lilly has submitted Orforglipron for regulatory review in more than 40 countries, including the UK. It is not yet clear whether the brand name Foundayo will be used in other markets. 

Key Takeaways 

● FDA has approved a new once-daily oral GLP-1 treatment (Orforglipron) in the US 

● UK availability is not yet confirmed, but regulatory submissions are underway 

● Clinical trials showed significant weight loss versus placebo, with the convenience of a tablet formulation 

How do GLP-1 tablets work? 

The active ingredient, Orforglipron, belongs to a group of medicines called GLP-1 receptor agonists. These treatments are designed to help regulate appetite in a similar way to injectable weight loss medications. 

It works by copying the action of a natural hormone in the body that helps control hunger and digestion. This can help you feel less hungry and feel fuller for longer, which may support weight loss over time.

This is an important development in weight management because GLP-1 treatment is now available as a tablet, when historically the most effective medicines in this class were only available as injections. 

How is Orforglipron taken? 

Unlike other GLP-1 tablets, it’s a small-molecule drug, meaning it can be taken more flexibly, without strict food or timing rules. 

The oral medication may be a suitable option for patients who: 

● Prefer a needle-free approach, helping to ease any discomfort or hesitation around injections 

● Value simplicity and convenience, with a once-daily tablet that fits gently into everyday routines 

● Would like a treatment that’s easy to store and travel with, without the need for refrigeration like some injectable medications 

Are results different between GLP-1 tablets and GLP-1 injections? 

Generally, oral GLP-1 medications are slightly less effective than injectable treatments, although the difference is becoming smaller with newer treatments. 

The main evidence for Orforglipron comes from the ATTAIN-1 trial, a 72-week randomised, double-blind, placebo-controlled study published in the New England Journal of Medicine. 

The study included 3,127 adults who were living with obesity or overweight (with at least one weight-related health condition) and did not have type 2 diabetes. 

In this clinical trial, participants taking Orforglipron achieved an average weight loss of 12.4% at the highest dose. 

A separate maintenance study (ATTAIN-MAINTAIN) also found that the medication helped patients sustain weight loss over time after initial treatment. 

These findings point to a potential treatment approach that hasn’t previously been available; achieving weight loss with the more effective injectable therapy, then switching to a simple daily pill to help maintain the results. 

Are the side effects different between GLP-1 tablets and GLP-1 injections? 

Like any medicine, Orforglipron may cause side effects in some people. In most cases these are mild and temporary, often improving as the body adjusts to the treatment, and they are more likely to occur at the start of treatment or following an increase in dose. 

Overall the side effect profile appears similar to GLP-1 injections where it mainly affects the digestive system, and the most common side effects including nausea, vomiting, diarrhoea, constipation, and stomach pain. 

In clinical trials, a small percentage of participants (around 3.5% to 7.0%) stopped treatment due to stomach-related side effects. 

When will Foundayo be available from Cloud Pharmacy? 

Foundayo (Orforglipron) has recently received FDA approval in the US, and regulatory decisions in the UK are underway. As and when there are updates on MHRA approval, we will make sure this information is relayed directly to our patients. 

In the UK, there are currently no MHRA-licensed Orforglipron tablets available for prescription. GLP-1 medications should only be obtained through regulated healthcare providers and licensed UK pharmacies to ensure safety, authenticity, and clinical appropriateness. 

At Cloud Pharmacy, we understand that navigating new treatment options can feel complex. We’re here to keep you informed as developments unfold, offer trusted guidance to help you make confident decisions about your health and wellbeing, and support you every step of the way by providing personalised care throughout your weight loss journey. 

References 

1. https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program 

2. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill 

3. https://www.nejm.org/doi/full/10.1056/NEJMoa2511774 

4. https://investor.lilly.com/news-releases/news-release-details/lillys-orforglipron-helped-people-maintain-weight-loss-after 

 

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Sana Javed

Sana Javed

Prescribing Pharmacist

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