๐Ÿšจ FDA Decision Imminent โ€” NDA submitted Dec 2025. Priority Review Voucher granted. Track status โ†’

Orforglipron FAQ

Answers to the most common questions about availability, cost, eligibility, comparisons, and what to expect from the oral GLP-1 pill.

Availability & FDA Status
When will orforglipron be available?
Eli Lilly submitted the New Drug Application to the FDA in December 2025, and orforglipron received the FDA's Commissioner's National Priority Review Voucher โ€” the first drug ever selected for this new program. This voucher compresses the FDA review timeline to potentially weeks to 1โ€“2 months rather than the standard 6โ€“10 months. A decision and commercial launch is expected in 2026, potentially very early in the year. Check our FDA Status page for the latest updates.
Is orforglipron FDA approved?
Not yet as of early 2026 โ€” but the NDA has been submitted and is under priority review. It has not been approved by any regulatory agency yet. It is currently only available to participants in ongoing clinical trials.
Where can I get orforglipron right now?
Currently, orforglipron is only accessible through clinical trials. You can search for open trials at clinicaltrials.gov using the search term "orforglipron" or "LY3502970". Once approved, it will be available via prescription through standard pharmacy channels.
Cost & Insurance
How much will orforglipron cost?
Under agreements with the US government announced in November 2025, Eli Lilly has committed that upon approval, self-pay patients can access orforglipron through LillyDirect's self-pay pharmacy channel with the lowest dose starting at $149/month and higher doses up to $399/month. This is dramatically lower than injectable alternatives like Wegovy (~$1,350/month) or Zepbound (~$1,060/month). Insurance coverage decisions will vary by plan and will be determined in the months following approval.
Will insurance cover orforglipron?
Insurance coverage decisions haven't been made yet โ€” they'll be negotiated after FDA approval. Historically, coverage for obesity drugs has been inconsistent, though coverage has been improving as GLP-1 drugs have become mainstream. The significantly lower price point of orforglipron compared to injectables may make insurance coverage easier to obtain. Lilly's self-pay $149 starting price also makes it accessible without insurance.
Eligibility & Use
Who will be eligible for orforglipron?
Based on the NDA submitted, orforglipron is intended for adults with obesity (BMI โ‰ฅ30) or overweight (BMI โ‰ฅ27) with at least one weight-related health condition such as high blood pressure, high cholesterol, sleep apnea, or type 2 diabetes. This is the same broad eligibility as Wegovy and Zepbound. Exact prescribing criteria will be defined in the approved label.
Does orforglipron need to be taken with food?
No โ€” this is one of orforglipron's key advantages. It can be taken at any time of day, with or without food, with any beverage. There is no fasting window or water restriction required, unlike oral semaglutide (Rybelsus), which must be taken on an empty stomach with only a small amount of water.
How is orforglipron dosed?
In clinical trials, patients started at 1mg once daily and increased in steps every 4 weeks: 1mg โ†’ 3mg โ†’ 6mg โ†’ 12mg โ†’ 24mg โ†’ 36mg, reaching their maintenance dose of 6mg, 12mg, or 36mg. This gradual titration minimises GI side effects. The exact approved dosing will be confirmed when the drug is approved and labelled.
Comparisons
How does orforglipron compare to Ozempic/Wegovy (semaglutide)?
Orforglipron produces roughly similar weight loss to injectable semaglutide โ€” around 12% vs ~15% for Wegovy. The key differences are format (pill vs injection), convenience (no restrictions vs weekly shots), cost ($149 vs ~$1,350/month), and availability (global supply easier for pills). For many patients, the convenience and cost advantage of orforglipron will outweigh the modest weight loss gap. See our full orforglipron vs semaglutide comparison.
Can orforglipron replace my injectable GLP-1?
The ATTAIN-MAINTAIN trial showed that patients who had achieved significant weight loss on injectable Wegovy or Zepbound could switch directly to orforglipron and maintain virtually all of their weight loss over 52 weeks. This suggests orforglipron could serve as a maintenance-phase replacement for injectables โ€” gaining the weight loss benefits of more powerful injections initially, then transitioning to the easier, cheaper pill for long-term maintenance.
How does orforglipron compare to retatrutide?
Retatrutide is Eli Lilly's other investigational drug โ€” an injectable triple agonist (GLP-1 + GIP + Glucagon) that showed ~24% weight loss in Phase 2 trials. Orforglipron produces ~12% weight loss but has the major advantage of being a daily pill. These drugs serve different patient populations: retatrutide for maximum weight loss in severe obesity, orforglipron for the much larger population who prefer a convenient oral treatment. See our full comparison. For more on retatrutide, visit Retatrutide-RX.com.
Disclaimer: This FAQ is for educational purposes only and does not constitute medical advice. Orforglipron is not yet FDA approved. Always consult a licensed healthcare professional. Not affiliated with Eli Lilly and Company.