FDA cleared Eli Lilly’s obesity pill Foundayo (orforglipron) on April 1, dropping it into a $9.3 billion oral weight-loss market where Novo Nordisk’s oral Wegovy already had a three-month head start.
The efficacy numbers favor Novo for now. Oral Wegovy produced 16.6% weight loss at 72 weeks in Phase 3; Foundayo hit 11.2% over the same period. There’s no head-to-head trial between the two pills yet. Foundayo did beat Novo’s older Rybelsus in a February head-to-head, cutting patients’ weight by 19.7 lbs versus 11.0 lbs for oral semaglutide.
Foundayo’s label isn’t as clean as BMO Capital Markets suggested. The FDA is requiring data from an additional clinical trial to assess a signal of a serious risk of retained gastric contents, and to identify what the approval letter calls “an unexpected serious risk” for MACE, drug-induced liver injury, and exposure during lactation. Lilly’s pill may also reduce the effectiveness of oral contraceptives, a caution absent from oral Wegovy’s label.
Lilly has the manufacturing edge: Foundayo launched as a tablet rather than the capsule used in Phase 3 trials, requiring fewer active pharmaceutical ingredients. Pricing is competitive: it’s $149 to $299 per month for both, or as low as $25 through insurance.
Early script counts favor Wegovy. Oral Wegovy reached 3,000 patients its first week; Foundayo hit 1,390 prescriptions, though RBC Capital Markets notes Foundayo’s count reflects two days of sales versus five. Oral Wegovy hit 113,354 prescriptions in week 12, up 7.6% week-over-week. The $9.3 billion market is forecasted by 2035, and Pfizer, Structure Therapeutics, and Viking Therapeutics are all in the queue.
— Sarah Chen