What’s new in the GLP-1 market? You guessed it: the second oral GLP-1 therapy is here. On April 1, 2026, Fundayo (orforglipron) received FDA approval for weight reduction and maintenance in adults with obesity or overweight adults with one comorbid condition related to their weight. Importantly, the medication is to be used in combination with an increase in physical activity and a reduced calorie diet.[1] This announcement comes just three months after oral Wegovy started to occupy pharmacy shelves.
How does Fundayo compare to oral Wegovy?
With full adherence, oral Wegovy resulted in a 16.6% mean weight loss[2], while Foundayo yielded just a 12.4% mean weight loss reduction.[3] Despite the significant variance in performance, Fundayo does have unique advantages. It can be taken without any dietary restrictions, at any time of the day. Unlike Wegovy, which must be taken in the morning, on an empty stomach, with a full glass of water followed by 30 minutes of fasting.
The dosing flexibility Fundayo offers would be beneficial for those who are may not want to use injectables, have less regimented schedules, or struggle with adherence. The added convenience of the oral dosage form, combined with the freedom from special storage requirements is another incentive for consumers.
Another advantage is in its chemical structure. Foundayo is a small molecule weighing 902g/mol about 4 times less than that of oral Wegovy.[4] The significance here is that due to the cyclical supply and demand shortage with GLP-1s, it may be cheaper, and easier to manufacture Foundayo which could ensure constant supply. Eli Lily’s CEO even boasted, “We can make basically as much as we need”, suggesting that the company would be able to meet high demand. For providers, initiating a patient on a readily accessible therapy could provide better outcomes as it would be easier to maintain adherence.
What about the Disadvantages?
Because Foundayo is metabolized by the CYP3A4 enzyme, it is advised to not be used with any strong CYP3A4 inhibitors or inducers due to clinically significant drug-drug interactions. CYP3A4 inhibitors include several commonly prescribed drugs, such as Clarithromycin, Verapamil, and Carbamazepine.
Foundayo may also interact with certain statin drugs, which would require a thorough risk-benefit analysis. For example, if Foundayo was taken with Simvastatin, it would lead to a 2—2.5-fold increase in drug exposure, which would greatly heighten the chances of rhabdomyolysis (a painful, potentially life-threatening condition where one could experience sever muscle pains, weakness and dark colored urine).[5] Despite this interaction, Simvastatin was not listed as a contraindication. Should a patient be on both medications, the max Foundayo dose would be 9mg, rather than the regular max dose (17.2mg) that yields the largest weight loss.[6]
Foundayo also stimulates insulin release, and can cause hypoglycemia in those using insulin and/or insulin secretagogues like sulfonylureas and metaglinides. For these patients, they would need to consistently monitor their blood sugar and understand the manifestations of low blood sugar.
How Well is Foundayo Tolerated?
During the clinical trials, about 7% of participants who received Foundayo had to discontinue the therapy due to adverse events.[7]The most common side effects are consistent with what we’ve observed with the injectable GLP-1s: gastrointestinal effects such as nausea, constipation, diarrhea, and dyspepsia ranging from mild to moderate.
Eli Lilly plans to launch Fundayo this Monday April, 6th. Having already anticipated insurance formulary restrictions, Eli Lily offers a self-pay program, LillyDirect, which mirrors NovoNordisks self-pay program for oral Wegovy. Both programs price the lowest doses at $149 per month and the highest doses at $299 per month.
Foundayo was reviewed through the Commissioner’s National Priority Voucher (CNPV) program which is aimed at accelerating the drug approval process in order to provide therapeutic options to Americans in a timely manner. The FDA’s to approval of Foundayo just 50 days after Lilly filed for approval, makes history as the fastest drug approval in the over 2 decades. Yet, in the ever-growing wake of class action suits against GLP-1 medications, one has to wonder if 50 days was adequate to ensure patient safety.
[1] https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program
[2] https://www.appliedclinicaltrialsonline.com/view/fda-approves-oral-wegovy-positive-oasis-trial-results?utm_source=copilot.com
[3] https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill
[4] https://www.managedhealthcareexecutive.com/view/foundayo-vs-oral-wegovy-the-similarities-the-differences-and-what-you-need-to-know
[5] https://www.uptodate.com/contents/rhabdomyolysis-clinical-manifestations-and-diagnosis
[6] https://pi.lilly.com/us/foundayo-uspi.pdf
[7] https://www.nejm.org/doi/full/10.1056/NEJMoa2511774
As Told By a Pharmacist 
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