Eli Lilly has developed an innovative daily oral pill called orforglipron, which shows promising potential to help people lose up to 20% of their body weight, based on successful phase 3 trial results involving over 3,000 adults with obesity.

Orforglipron is a GLP-1 receptor agonist that not only aids weight loss but also lowers blood sugar, slows digestion, and reduces appetite, similar to existing injectable medications like Mounjaro, but with the added advantage of being an oral formulation for greater accessibility.

Experts believe that the oral nature of this medication could significantly reduce the burden on healthcare systems and improve global access to obesity treatments, potentially transforming current weight management strategies.

The drug has demonstrated impressive efficacy, with participants achieving an average weight loss of 10.5% (about 23 pounds), and also showing improvements in blood pressure, cholesterol, and waist circumference, with some prediabetic individuals reversing their condition.

Additionally, higher doses of orforglipron reduced inflammation markers, such as high-sensitivity C-reactive protein by nearly 48%, indicating potential anti-inflammatory benefits.

Lilly plans to submit orforglipron for regulatory approval later in 2025, aiming for a global launch by late 2026, with the UK expected to be among the first countries to receive the medication.

The development of this oral drug is strategically significant because it addresses the high U.S. obesity rate, affecting about 40% of adults, and offers a lower-cost alternative to expensive injectable options, which can cost nearly $8,000 annually.

Analysts estimate that if approved early or launched ahead of schedule, orforglipron could generate an additional $1 billion in revenue for Lilly, with a typical monthly price around $400, making it more affordable.

The FDA has committed to issuing five nontransferable fast-track vouchers in 2025 to expedite the review process for drugs meeting criteria related to public health, innovation, and unmet needs, and Lilly is optimistic about leveraging this pathway.

This fast-tracking is part of the FDA's broader efforts to reduce drug approval times and lower pharmaceutical costs, aligning with initiatives to make obesity treatments more accessible and affordable.

Lilly's orforglipron benefits from the FDA's new 'Commissioner’s National Priority Voucher' program, which aims to accelerate approval for drugs addressing significant public health issues, including obesity.

The synthetic nature of orforglipron could give Lilly more flexibility on pricing compared to peptide-based competitors like Novo Nordisk, potentially making the drug more competitive in the market.

Beyond weight loss, Lilly is exploring orforglipron's potential for treating related conditions such as obstructive sleep apnea and hypertension associated with obesity.