Lilly prepares to launch orforglipron for obesity; FDA decision expected imminently –
Shipping can begin within a week of approval; OUS access will begin in 2027+
In TD Cowen’s 46th annual Health Care Conference, Lilly’s EVP and CFO, Mr. Lucas Montarce, provided updates on its cardiometabolic portfolio, including oral GLP-1 RA orforglipron. See webcast here.
If approved, Lilly is prepared to launch orforglipron in the US immediately
He said that the FDA decision for orforglipron as a treatment for chronic weight management is expected in early 2Q26, consistent with previous reports. Lilly is preparing the launch so that, if approved, orforglipron can be shipped within a week. The company said in 3Q25 that it would “immediately” begin global regulatory filings for the obesity indication.
Outside the US, Lilly has filed for approval in the EU and Japan as of 4Q25, and expects to launch in global markets in 2027. Of note, the regulatory submission for T2D has been completed in the EU and is planned for 2026 in the US and Japan. Mr. Montarce believes that orforglipron can significantly expand the GLP-1 RA market by enabling global manufacturing and offering an oral option for needle-averse patients.
Orforglipron will be available via LillyDirect and covered by Medicare
On access and pricing, Mr. Montarce said that orforglipron will be available on LillyDirect at $149 per month for the starting dose and up to $399 per month. Under the Most Favored Nation pricing, orforglipron will be priced at $346 per month on TrumpRx.
On the insured channel, orforglipron will be covered under Medicare “no later than July 1” as a treatment for obesity and has the potential to be covered by Medicaid. This shift by Medicare to begin covering GLP-1 RAs for obesity has been slow to come – Novo Nordisk’s Wegovy became the first eligible for Medicare Part D coverage in March 2024 for cardiovascular risk reduction in patients with obesity, circumventing Medicare’s statutory prohibition from covering drugs used solely for weight loss. Lilly is currently undergoing discussions with pharmacy benefit managers (PBMs) to expand commercial access.
Lilly believes orforglipron will lead the oral GLP-1 RA market
If approved, orforglipron will be the second oral GLP-1 RA to the obesity market after oral Wegovy. Lilly believes orforglipron is competitive given that it has no food or water restrictions and will become a market leader over time, just like Zepbound, which captured 69% of new-to-brand prescriptions at the end of 4Q25 – two years after its launch.
To ensure sufficient supply for a global launch, Lilly has prepared ~$1.5 billion in pre-launch orforglipron inventory. Mr. Montarce said that this should not be a proxy for 2026 revenue, however.
Appendix: Topline results of the ATTAIN program show promising weight loss and A1c reduction in people with obesity and other comorbidities
The phase 3 ATTAIN program has worked to assess orforglipron in people with obesity and other comorbidities. This includes:
- ATTAIN-1 (n=3,127), which assessed orforglipron on weight management in adults with obesity or overweight with related conditions but not T2D. Topline results were announced in the 2Q25 call, showing that orforglipron conferred up to 12% weight loss in people with obesity (vs. -0.9% with placebo), with ~60% achieving ≥10% weight reduction and 40% achieving ≥15%.
- ATTAIN-2 (n=1,613), which assessed weight loss efficacy of orforglipron in adults with obesity or overweight and T2D (n=1,500). Topline results reported in August 2025 showed that orforglipron 36 mg confers 11% weight loss (vs. 2% in placebo) and A1c reduction by 1.8% (vs. 0.1%) in adults with obesity and T2D.
- ATTAIN-MAINTAIN (n=300), an extension of the SURMOUNT-5 trial, aims test orforglipron as a potential maintenance therapy for patients who have lost weight on injectable incretin therapies like Zepbound. Topline results announced in December 2025 showed only 1-6% body weight gain after switching from injectable semaglutide or tirzepatide to orforglipron over 52 weeks.
- ATTAIN-OSA (n=600), which evaluates orforglipron in people with moderate-to-severe sleep apnea and obesity or overweight. The study is expected to complete in January 2027.
- ATTAIN-HYPERTENSION (n=487), which evaluates orforglipron for managing high blood pressure in adults with overweight or obesity. Launched in April, the study is currently recruiting participants and is expected to complete in September 2027.
-- by Kat Moon, Monica Oxenreiter, and Kelly Close