FDA Approves New GLP-1 Pill as Ozempic MDL Approaches Pretrial Deadlines

The FDA approved Eli Lilly's Foundayo (orforglipron) on April 1, 2026, the first oral GLP-1 weight loss medication that can be taken without food or water timing restrictions. The approval expands a drug class that is the subject of coordinated federal litigation, with 3,363 cases pending in MDL 3094 and summary judgment and Daubert deadlines scheduled for late April.

Foundayo's commercial launch began April 6 through Eli Lilly's LillyDirect digital pharmacy, with pricing set at $25 per month for commercially insured patients and $149 to $349 per month for self-pay, lower than current injectable GLP-1 list prices. The medication received approval in 50 days under the FDA's National Priority Voucher program.

Clinical Background on Foundayo

Foundayo is a non-peptide, small-molecule GLP-1 receptor agonist, representing a different chemical structure from injectable semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) products. In the ATTAIN-1 clinical trial of 3,127 adults, participants on the highest dose (36 mg) achieved an average 12.4% weight reduction over 72 weeks.

Unlike oral semaglutide formulations that require 30 minutes of fasting with plain water, Foundayo can be taken with or without food, which analysts expect will drive broad patient adoption.

GLP-1 Class Medications

The GLP-1 drug class currently includes nine FDA-approved brand medications across two primary manufacturers:

Novo Nordisk: Ozempic and Rybelsus (semaglutide for type 2 diabetes), Wegovy injection and oral formulation (semaglutide for chronic weight management), Victoza and Saxenda (liraglutide)

Eli Lilly: Mounjaro (tirzepatide for type 2 diabetes), Zepbound (tirzepatide for chronic weight management), and Foundayo (orforglipron for weight management)

Eli Lilly is a named defendant in MDL 3094 regarding Mounjaro. Foundayo adds an oral product to the company's portfolio as market adoption expands.

MDL 3094 Pretrial Schedule

MDL 3094, consolidated before Judge Karen S. Marston in the Eastern District of Pennsylvania, is approaching key procedural milestones. Expert discovery closed in late March 2026. Daubert motions to challenge expert testimony are due April 28, with summary judgment motions scheduled for April 30.

Plaintiffs allege that GLP-1 receptor agonists cause severe gastrointestinal conditions, including gastroparesis, bowel obstruction, necrotizing pancreatitis, gallbladder disease, and aspiration injuries during anesthesia. The FDA added a gastroparesis warning to the Ozempic label in October 2025.

Vision Loss Litigation in MDL-3163

A July 2024 study published in JAMA Ophthalmology by researchers at Massachusetts Eye and Ear reported that patients taking semaglutide had a 4.28-fold increased risk of developing NAION (non-arteritic anterior ischemic optic neuropathy), with overweight patients experiencing a 7.64-fold higher risk.

These findings resulted in more than 140 vision loss lawsuits that were severed into a separate multidistrict litigation, MDL-3163, in December 2025.

Wrongful Death Claims

In March 2026, the family of Marsha Ettinghoff, a 76-year-old patient who died from complications of gastroparesis after six months of Ozempic therapy, filed a wrongful death action. The complaint alleges symptoms were initially attributed to food poisoning prior to fatal pulmonary aspiration during medical transport.

Market Dynamics and Pricing

On February 24, 2026, Novo Nordisk announced plans to lower Wegovy list prices by approximately 50% and Ozempic by approximately 35%, effective January 1, 2027. On March 31, the company introduced direct-to-consumer self-pay subscriptions through telehealth providers.

Foundayo's pricing structure ($25 per month with insurance) introduces further pricing adjustments across the market, supporting wider patient adoption.

Next Steps for Law Firms

Summary

GLP-1 litigation continues to develop as new formulations enter the market. Foundayo's approval expands the treatment category to oral small molecules, while MDL 3094 approaches key judicial determinations on general causation and warning adequacy.

Law firms evaluating GLP-1 claims require comprehensive records across primary care physicians, gastroenterologists, and imaging facilities.

Sources: FDA, Eli Lilly, MDL Update, JAMA Ophthalmology, Reuters, Novo Nordisk.