Novo Nordisk submits weight loss pill for US approval

Novo Nordisk has submitted a pill version of its obesity drug for approval by the US Food and Drug Administration, the company has confirmed.

The oral formulation is based on semaglutide, the same active ingredient used in the company’s injectable obesity treatment Wegovy and diabetes medication Ozempic. In 2023, Novo reported positive results from a Phase 3 trial in which participants taking the highest oral dose lost around 15 per cent of their body weight after 64 weeks.

Despite these findings, the Danish pharmaceutical firm initially delayed filing for approval, citing the need to prioritise other obesity treatments and address manufacturing capacity constraints. The company has since expanded production to meet surging global demand for semaglutide-based treatments.

Novo’s filing comes amid growing competition from Eli Lilly, which is developing its own oral GLP-1 drug, orforglipron. Lilly recently announced strong results in a diabetes trial and is awaiting results from an obesity study before seeking approval.

Although Novo already markets oral semaglutide under the brand name Rybelsus for diabetes, the obesity version uses a significantly higher 25mg daily dose. As a peptide drug, it is more complex to manufacture than traditional small-molecule pills, raising questions about production scalability.

Novo is also advancing a combination therapy known as CagriSema, although progress has been slowed by underwhelming trial results. The company previously stated it aimed to submit its oral obesity treatment for approval in 2023 but held off pending strategic decisions on its wider portfolio.

Further updates on the approval process are expected when Novo reports its first-quarter earnings on 7 May.