The BBC has contacted the FDA for comment.
The Wegovy pill showed an average weight loss of 16.6% during Novo Nordisk’s trials, the firm said, external on Monday.
A third of around 1,300 participants experienced 20% or greater weight loss in the same trial, it added.
The pill is expected to be launched in the US in early January 2026.
“Patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” said Mike Doustdar, the firm’s chief executive.
The pill version of Wegovy could give Novo Nordisk’s sales a boost after a challenging year which saw its shares slide as it warned over its profits.
The company has faced intense competition in the weight-loss market from rival drugmakers like Eli Lilly.
Novo Nordisk’s shares rose by almost 10% in after-hours trade in New York after the announcement.
