A daily weight-loss pill that requires no needles, no refrigeration, and no mealtime restrictions went on sale April 6 at $149 per month.

The FDA approved Eli Lilly's Foundayo (orforglipron) on April 1, making it the first oral GLP-1 drug that can be taken any time of day without food or water restrictions. More than 20,000 people nationwide started taking it in the first few weeks, with over 1,000 new patients beginning each day, Lilly CEO Dave Ricks told CNBC in late April.

What Makes It Different

Unlike injectable options like Ozempic or Zepbound, Foundayo is a small-molecule pill manufactured through standard chemistry rather than complex biological processes. That distinction matters: injectable GLP-1 drugs have faced persistent supply shortages nationwide.

In clinical trials, patients on Foundayo lost an average of 12% to 15% of body weight over 72 weeks. More than 80% of prescriptions are going to patients who have never used a GLP-1 drug before, according to Lilly's quarterly earnings report.

Safety and What's Still Being Studied

A large trial called ACHIEVE-4, enrolling 2,700 participants across 15 countries, showed no signs of drug-induced liver injury and found a 57% lower risk of all-cause death compared to insulin glargine. About 10.6% of patients discontinued treatment in the first year, mainly due to gastrointestinal side effects like nausea.

The FDA is requiring Lilly to conduct a post-market study running through 2043 to assess possible risks including cardiovascular events, liver injury, and delayed gastric emptying.

Access and Cost

Foundayo is available at Walmart's 4,300 pharmacies nationwide. Amazon One Medical launched a GLP-1 management program in April with insured pricing starting at $25 per month. Beginning July 2026, eligible Medicare Part D beneficiaries will gain access to certain GLP-1 medications at $50 per month through a program called the Medicare GLP-1 Bridge. Nearly half of employer insurance plans now cover anti-obesity drugs.

Roughly 40% of U.S. adults live with obesity, and about 1 in 8 report having ever used a GLP-1 medication.

Lilly is also testing a more powerful injectable called retatrutide, which targets three hormone receptors and produced up to 28.7% weight loss in Phase 3 trials. It has not been submitted to the FDA and has no confirmed approval timeline.

The Medicare GLP-1 Bridge program opens in July.