- FDA approves first oral GLP-1 for weight loss, with $149 monthly starting dose
- Novo stockpiles supply at North Carolina facilities to avoid repeat of 2021 shortages
Novo Nordisk received FDA approval Monday (22nd December) for oral Wegovy (semaglutide), marking the first oral GLP-1 receptor agonist cleared for obesity treatment. The Danish drugmaker plans a full US launch in early January 2026, with manufacturing underway at its North Carolina facilities.
Shares in Novo rose 7% Tuesday following the announcement.
The approval positions Novo ahead of rival Eli Lilly, whose oral GLP-1 orforglipron awaits FDA clearance expected in Q1 2026. Novo has priced the 1.5 mg starting dose at $149 per month for self-pay patients through pharmacies and select telehealth providers, part of an agreement announced with the Trump administration in November.
“Wegovy pill is the next chapter in our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity,”
Dave Moore, Novo’s EVP of US operations, said in a December 22 statement
“We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities.”
The FDA based its approval on data from the phase 3 Oasis-4 trial, where patients on oral Wegovy who adhered to treatment achieved 16.6% average weight loss versus 2.7% for placebo at 64 weeks. The oral formulation showed comparable efficacy to subcutaneous Wegovy in an indirect treatment comparison presented at ObesityWeek 2025 in Atlanta.
Novo has stockpiled supply following years of shortages that plagued injectable Wegovy after its 2021 launch. CEO Maziar Mike Doustdar told investors the company has “more than enough pills” to meet demand. The oral formulation requires a 25 mg daily maintenance dose, more than ten times the highest approved dose of injectable Wegovy, due to first-pass metabolism through the gut and liver.
