The race is on to bring the first GLP-1 obesity pill to market, and Novo Nordisk's oral version of Wegovy is projected to be the first across the finish line, with Eli Lilly's orforglipron coming in a close second.
As the two rival titans fight for dominance, others are eager to get in on the action, especially with oral options expected to capture around 20% of the $80 billion obesity GLP-1 market by the end of the decade.
Among the potential competitors is Pfizer, which has shifted efforts to rebuilding and diversifying its weight-loss drug pipeline after halting development of two GLP-1 pills due to safety concerns.
The pharma giant acquired the obesity biotech company Metsera last month, bringing on board a robust lineup of GLP-1 and next-generation obesity drugs, including an early-stage oral option. But Pfizer didn't stop there.
The large pharma also struck a major licensing deal with YaoPharma, a subsidiary of China’s leading drugmaker Shanghai Fosun Pharmaceutical, last week to develop and commercialize another early-stage obesity pill, advancing Pfizer's presence in weight loss R&D.
The global market for weight-loss drugs, projected to reach $150 billion by 2035, is enticing to foreign drugmakers, as well.
Ascletis Pharma, a Chinese biotech, entered the ring last week after announcing mid-stage results of its oral GLP-1 drug. But the data puts the company's pill in the mid-lower tier of a wave of oral obesity readouts when it comes to efficacy.
With at least six different oral GLP-1 drugs in mid-stage development or beyond, these three are leading the clinical pack.
Structure Therapeutics boasts strong results
Structure Therapeutics grabbed headlines this month when it reported two positive clinical readouts for the investigational oral GLP-1 pill aleniglipron, and the company's shares jumped more than 100%.
After 36 weeks in a core mid-stage trial, patients taking the highest dose achieved placebo-adjusted average weight loss over 11%, with 86% losing at least 5% of body weight and 70% losing at least 10%.
In Structure’s separate, ongoing 44-week exploratory study, participants lost up to 15.3% of their body weight, depending on the dose.
Aleniglipron was tolerated about the same as other GLP-1 therapies, even at the highest dose, but still triggered gastrointestinal events — the most common challenge in the space next to muscle loss. Structure is also running a 40-week phase 2 study to test aleniglipron with a different dosing regiment, which could improve side effects.
Looking ahead, Structure is slated to advance aleniglipron to late-stage testing, and is aiming for an end-of-phase-2 meeting with the FDA early next year before phase 3 trials potentially start in mid-2026.
Novo Nordisk's next-gen pill
After two closely watched studies failed to show that Novo Nordisk's oral semaglutide slows the progression of Alzheimer's disease last month, the company rebounded with a mid-stage win for its next-generation obesity drug amycretin.
A phase 2 diabetes study of nearly 450 adults tested injectable and oral doses, showing that daily oral amycretin triggered a placebo-adjusted weight loss of 7.6% with no plateau.
And although a dropout rate wasn't given, most adverse events reported while taking the drug were mostly mild to moderate in severity, the study investigators noted.
Novo is planning to move both subcutaneous and oral formulations of amycretin into phase 3 for obesity in the first quarter of 2026. The company says its novel single-molecule GLP-1 and amylin receptor agonist could potentially offer a "best-in-class profile," positioning it as a possible rival to Lilly's orforglipron.
Viking Therapeutics' stays in the chase
Viking Therapeutics made a splash in August when it announced that the oral obesity candidate VK2735 hit its mark in a phase 2 trial. On the downside, however, the drug led to a high rate of discontinuation.
The company’s results were still strong enough to keep it among the largest contenders for a weight loss pill.
In the mid-stage Venture‑oral dosing study patients taking the highest dose lost a placebo-adjusted average of 10.9% after only 13 weeks. No weight loss plateau was observed, setting the stage for further weight reduction in a longer study.
But the drug's side effects and rate of discontinuation had investors worried.
Across all dosing levels tested, 28% of participants in the study stopped treatment, compared to 18% who took a placebo, which was primarily driven by nausea and vomiting. But slowing the rate of dose titration may improve the drug's tolerability profile, the company said.
Viking has already started phase 3 testing on its injectable version of VK2735 and is expected to move the pill version into phase 3 as well, although the timeline is unclear.