Current Status: NDA Submitted
🟡 NDA Under FDA Review
Eli Lilly submitted a New Drug Application to the FDA for orforglipron for the treatment of adults with obesity or overweight in December 2025. The application has been granted a Commissioner's National Priority Review Voucher — the first drug selected for this new program — which dramatically accelerates the review timeline.
What the Priority Voucher means: Under the standard FDA review process, a decision typically takes 6–10 months after NDA submission. The Commissioner's National Priority Review Voucher compresses this to potentially weeks to 1–2 months for drugs treating high-burden chronic conditions. FDA approval and commercial launch could follow very quickly thereafter.
Full Regulatory Milestone Timeline
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2018✓ Done Eli Lilly licenses orforglipron from Chugai Pharmaceutical. Worldwide development rights secured.
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2022–2023✓ Done Phase 2 trials completed. Positive results in obesity and type 2 diabetes trigger Phase 3 investment.
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April 2025✓ Done ACHIEVE-1 Phase 3 topline results (type 2 diabetes) announced. Full results published in NEJM in June 2025.
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Aug 2025✓ Done ATTAIN-1 and ATTAIN-2 topline Phase 3 results announced for obesity. Full ATTAIN-1 results published in NEJM in September 2025.
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Sep 2025✓ Done ACHIEVE-3 results — head-to-head vs. oral semaglutide — announced. Orforglipron demonstrates superior results.
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Nov 2025✓ Done Lilly and US government agree: starting dose priced at $149/month upon approval for self-pay patients.
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Dec 2025✓ Done ATTAIN-MAINTAIN Phase 3 results announced — orforglipron successfully maintains weight loss after switching from injectable Wegovy or Zepbound. NDA submitted to FDA simultaneously. Priority Voucher granted.
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Early 2026Active FDA review underway. PDUFA date expected to be announced. Priority Voucher means review could complete in weeks.
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2026Anticipated FDA approval decision and commercial launch. Type 2 diabetes NDA submission also planned by Lilly in 2026.
What Is the Commissioner's National Priority Voucher?
The Commissioner's National Priority Review Voucher is a new FDA pilot program launched to accelerate approval of drugs treating high-burden chronic conditions that meet certain public health criteria. Orforglipron was the first drug selected for this program.
Under this program, the FDA commits to completing its review within a significantly compressed timeframe compared to the standard review process. Industry analysts and Lilly's own executives have indicated this could mean a decision within weeks to 1–2 months rather than the usual 6–10 months.
This is particularly significant because it means orforglipron could potentially be available to patients much earlier in 2026 than initially anticipated — potentially making it one of the fastest NDA-to-approval timelines for a major metabolic drug in recent history.
What Happens After Approval?
Eli Lilly has been preparing for orforglipron's commercial launch for some time. The company has announced major manufacturing investments including new facilities in Texas, Alabama, and Puerto Rico, plus expanded capacity in the Netherlands — all dedicated to orforglipron production. This suggests Lilly expects rapid uptake and is positioning for global scale.
Upon approval, orforglipron will be available through LillyDirect's self-pay pharmacy channel with the starting dose at $149/month, rising to up to $399/month for higher doses. Insurance coverage decisions will be made by individual payers over the months following approval.
Lilly also plans to submit a separate NDA for the type 2 diabetes indication in 2026, which would further expand the drug's potential patient population.