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

What Is Orforglipron?

The complete overview of Eli Lilly's investigational oral GLP-1 pill โ€” what it is, why it's different, and why it matters for the future of obesity treatment.

The Short Answer

Orforglipron (code name LY3502970) is a once-daily oral pill being developed by Eli Lilly and Company for obesity and type 2 diabetes. It belongs to the GLP-1 receptor agonist drug class โ€” the same class as blockbuster injectables Ozempic, Wegovy, and Zepbound โ€” but is taken as a simple tablet with no injection, no needle, and no food or water restrictions.

Lilly submitted a New Drug Application to the FDA in December 2025, and orforglipron was the first drug granted the FDA's new Commissioner's National Priority Review Voucher โ€” meaning approval could arrive within weeks to months.

The Big Breakthrough: Why a Pill Is So Hard

All existing effective GLP-1 drugs โ€” semaglutide (Ozempic/Wegovy), tirzepatide (Mounjaro/Zepbound), liraglutide (Saxenda) โ€” are peptide-based. Peptides mimic natural hormones effectively, but are destroyed by stomach acid and digestive enzymes if swallowed. This is why every major GLP-1 drug requires injections.

Orforglipron is a small-molecule, non-peptide compound engineered from scratch to survive the digestive system and be absorbed through the gut. This is a landmark pharmaceutical achievement โ€” and critically, it can be taken at any time of day, with or without food.

vs. Oral Semaglutide (Rybelsus): Rybelsus does exist but requires strict dosing โ€” empty stomach, only 4oz of water, 30-minute wait before eating. Orforglipron has zero restrictions. Take it with breakfast, coffee, at night โ€” whenever works. This is a fundamental real-world usability advantage.

Key Facts

CategoryDetails
Generic NameOrforglipron
Code NameLY3502970
DeveloperEli Lilly (licensed from Chugai Pharmaceutical, 2018)
Drug ClassSmall-molecule oral GLP-1 receptor agonist (non-peptide)
AdministrationOnce-daily oral tablet, any time, no food restrictions
Doses Studied6 mg, 12 mg, 36 mg once daily
Avg. Weight Loss~12.4% at 36mg (ATTAIN-1, 72 weeks)
FDA StatusNDA submitted Dec 2025; Priority Review Voucher granted
Starting Price$149/month upon approval (self-pay)
RefrigerationNot required
IndicationsObesity; Type 2 diabetes (separate NDA planned 2026)

Who Discovered It?

Orforglipron was originally discovered by Chugai Pharmaceutical Co., Ltd., a Japan-based Roche Group member. Eli Lilly licensed worldwide development and commercialization rights in 2018 and has led all Phase 2 and Phase 3 clinical development since. Lilly has also made major manufacturing investments โ€” new facilities in Texas, Alabama, Puerto Rico, and the Netherlands โ€” in preparation for commercial launch.

What Conditions Is It Being Studied For?

The primary NDA covers obesity and overweight with at least one weight-related condition โ€” the same broad indication as Wegovy and Zepbound. A separate NDA for type 2 diabetes is planned for 2026 based on the ACHIEVE Phase 3 program. Additionally, orforglipron is in Phase 3 studies for obstructive sleep apnea, hypertension, knee osteoarthritis, stress urinary incontinence, and cardiovascular outcomes.

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Also following retatrutide โ€” Eli Lilly's injectable triple agonist with ~24% weight loss in Phase 2? Visit our sister site Retatrutide-RX.com for comprehensive trial coverage, comparisons, and TRIUMPH Phase 3 updates.

Disclaimer: Educational purposes only. Orforglipron is investigational and not yet FDA approved. Not affiliated with Eli Lilly and Company.