The United States has approved the first "oral weight-loss miracle drug," with Novo Nordisk taking the lead and its stock price soaring, while Eli Lilly is expected to receive approval in March.

The United States has approved the first "oral weight-loss miracle drug," with Novo Nordisk taking the lead and its stock price soaring, while Eli Lilly is expected to receive approval in March.

Before Eli Lilly could react, Novo Nordisk has regained an edge in the competition for the US weight loss drug market.

On Monday, December 22, the US Food and Drug Administration (FDA) approved Danish pharmaceutical giant Novo Nordisk’s first oral GLP-1 weight loss drug. This new medication is the oral version of its blockbuster injectable product Wegovy, offering millions of obesity patients seeking more convenient treatments a new option.

The news immediately sparked positive reactions in the capital markets. In after-hours trading on the US stock market, Novo Nordisk's shares jumped as much as 10%, currently settling at around 8%. For Novo Nordisk, this approval marks a key victory, as its stock price had previously been under pressure this year over concerns about its competitive position.

This approval also puts Novo Nordisk temporarily ahead in its fierce race with main competitor Eli Lilly. According to Bloomberg, Eli Lilly’s own oral weight loss drug is expected to gain approval in March next year. This gives Novo Nordisk a valuable window of several months to consolidate its first-mover advantage in the oral medication market, which is emerging as the next core battleground for both giants following injectables.

Oral Drug Launches Early, Initial Pricing Strategy Revealed

According to Novo Nordisk’s statement, this oral drug will launch in the US in early January next year. The company disclosed its preliminary pricing strategy: the cash price for the initial dose will be $149 per month. The company also stated that for insured patients covering all doses, monthly costs could be as low as $25. Pricing for higher doses and more detailed insurance coverage and patient savings plans will be announced closer to the market launch.

Novo Nordisk CEO Mike Doustdar stated: “Oral Wegovy offers patients a brand new, convenient treatment option that can help them begin or continue their weight loss journey.” He emphasized that currently, no other oral GLP-1 therapy matches oral Wegovy’s weight loss efficacy.

The new drug will be sold through pharmacies and select telemedicine platforms. Dave Moore, Novo Nordisk's Executive Vice President of US Operations, told CNBC that offering an oral option can “activate and motivate different patient groups to seek treatment,” thereby expanding market coverage.

Supported by Clinical Data: Efficacy and Cardiovascular Benefits

FDA approval was based on the results of a Phase III clinical trial named Oasis 4. Trial data showed that patients taking a 25 mg daily dose lost an average of about 16.6% of their body weight after 64 weeks. This notable weight loss provides strong support for the drug’s effectiveness.

More importantly, the approved scope this time is not limited to weight loss. According to Novo Nordisk, the drug has also been approved for reducing the risk of major cardiovascular events (such as death, heart attack, or stroke) in obese adults with cardiovascular disease. This is consistent with the approval label for the company's injectable weight loss drug Wegovy, further enhancing its competitiveness.

Market Landscape Shifts, Competition with Eli Lilly Heats Up

Approval of the oral medication is key to Novo Nordisk's strategy. Reports indicate that the company has recently faced intense competition in the obesity market it pioneered. Its flagship drug Wegovy has lost some market share to Eli Lilly’s Zepbound, which a head-to-head trial showed has better weight loss effects.

Given this situation, oral Wegovy carries high hopes for Novo Nordisk, seen as the core driver to regain market initiative and fuel future growth. Although the lead window may only last a few months, entering the market first allows it to quickly build brand recognition and establish prescribing habits among physicians.

Bright Prospects for Oral Formulations, Convenience Is Key

Oral formulations are widely seen as the next growth engine for the weight loss drug market. According to a report by Goldman Sachs analysts, by 2030, oral drugs may account for 24% of the global weight loss drug market, worth about $22 billion.

However, this convenience also brings some usage differences. Novo Nordisk’s oral drug is a peptide; patients need to wait 30 minutes after taking it before eating or drinking. By contrast, Eli Lilly’s oral drug under development is reportedly not a peptide and is said to be absorbed more easily without similar dietary restrictions. Although current data suggest Novo Nordisk’s oral drug has a slight efficacy edge, future comparisons of real-world convenience and patient adherence between the two drugs will be key factors in determining market share.

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