FDA Clears Wegovy Pill as First Oral GLP-1 for US Weight Management

Novo Nordisk announced US Food and Drug Administration approval for the once-daily Wegovy pill (oral semaglutide 25 mg). This marks the first oral glucagon-like peptide-1 receptor agonist approved specifically for chronic weight control and cardiovascular risk reduction in adults with obesity or overweight plus comorbidities.

The therapy targets excess body weight reduction, long-term weight maintenance, and lowering major adverse cardiovascular events in eligible patients.

OASIS 4 Trial Shows Strong Weight Loss Results

Approval rests on the phase 3 OASIS programme and SELECT cardiovascular outcomes trial. In OASIS 4, a 64-week phase 3b study, 307 adults with obesity or overweight and at least one related condition received oral semaglutide 25 mg daily versus placebo.

Participants achieved average weight loss of 16.6% when adhering to treatment. One in three reached 20% or greater reduction, matching results from the injectable Wegovy 2.4 mg weekly dose. Safety aligned with prior semaglutide trials, showing familiar tolerability.

Broader OASIS Programme Details

OASIS includes four global phase 3 trials with about 1,300 adults evaluating oral semaglutide 25 mg and 50 mg doses for obesity management. These studies assess efficacy, weight maintenance, and metabolic benefits alongside safety over extended periods.

US Launch and Global Plans

Novo Nordisk plans US market entry for the Wegovy pill in early January 2026, complementing the established weekly injection. The company filed for EMA and other regulatory approvals in late 2025, with reviews underway internationally.

Dual Formulation Availability

Wegovy now offers US patients a choice: daily 25 mg oral tablet or weekly 2.4 mg injection, both for adults with obesity or overweight and weight-related conditions. The injectable version holds approvals from EMA and many global regulators, while the pill awaits similar clearances abroad.