Novo to weigh Wegovy rollout in India after US approval for oral pill

Novo Nordisk on Wednesday said the India launch of its newly approved oral obesity drug remains under evaluation and is subject to internal decisions and regulatory approvals, even as the company prepares for a US rollout early next year and advances filings with European authorities.

“The Wegovy pill is the first oral GLP-1 receptor agonist therapy approved by the US FDA for weight management. No other current oral GLP-1 treatment has the same magnitude of weight loss as delivered by Wegovy,” the company told Business Today.

The Danish drugmaker added that it expects to launch its blockbuster weight loss drug Wegovy in oral form in the US in early January 2026 and has submitted oral semaglutide 25 mg once daily for obesity to the European Medicines Agency (EMA) and other regulatory authorities.

“The India launch for this innovation is subject to internal decisions and due approvals from international and national regulatory authorities,” Novo Nordisk said, pointing to a staggered global rollout.

The company earlier announced that the US Food and Drug Administration has approved the once-daily Wegovy pill, or oral semaglutide 25 mg, to reduce excess body weight, maintain long-term weight loss and lower the risk of major adverse cardiovascular events.

The approval marks the first time an oral glucagon-like peptide-1, or GLP-1, receptor agonist has been cleared for weight management and is based on results from the OASIS clinical trial programme and the SELECT cardiovascular outcomes trial.

In the Phase 3 OASIS 4 study, once-daily oral semaglutide 25 mg delivered a mean weight loss of 16.6% in adults with obesity or overweight and at least one related comorbidity when treatment adherence was maintained. Around one in three participants achieved weight loss of 20% or more. The safety and tolerability profile was consistent with earlier semaglutide studies, the company said.

Novo Nordisk added that the weight loss achieved with the oral pill was comparable to that of the injectable version of Wegovy, which is administered once weekly and is already approved in multiple markets.

In India, Novo Nordisk launched injectable Wegovy in June 2025, initially pricing the drug in the range of roughly ₹17,000 to over ₹26,000 per month depending on dosage. The company later cut prices by about 37% to widen access, bringing lower-dose monthly costs closer to ₹11,000.