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Foundayo (orforglipron) Wins FDA Approval as First Anytime GLP‑1 Tablet for Weight Loss | iPharmaCenter

  • Badari Andukuri
  • Apr 8
  • 2 min read

The U.S. FDA has approved Foundayo (orforglipron), a once‑daily GLP‑1 tablet for chronic weight management in adults with obesity or overweight and weight‑related comorbidities. It is currently the only GLP‑1 pill for weight loss that can be taken at any time of day without specific restrictions on food or water intake.



Backed by the phase 3 ATTAIN programme, Foundayo delivered clinically meaningful and sustained weight loss.

  • In ATTAIN‑1, adults receiving the highest dose who remained on therapy for the full study period lost an average of 27.3 pounds, or 12.4% of their body weight, compared with 2.2 pounds (0.9%) in the placebo group.

  • When all participants assigned to Foundayo were analysed, regardless of whether they completed the trial, mean weight loss was 25 pounds (11.1%) versus 5.3 pounds (2.1%) with placebo.

  • Across the ATTAIN studies, treatment also improved several cardiometabolic markers, including waist circumference, non‑HDL cholesterol, triglycerides and systolic blood pressure across the dose range evaluated.


The FDA’s decision also represents a regulatory milestone. Foundayo is the first new molecular entity to be approved under the Commissioner’s National Priority Voucher (CNPV) pilot programme and is the fifth product overall to receive a decision through this pathway, with approval granted only 50 days after submission and well ahead of the original PDUFA date.



Foundayo is a glucagon‑like peptide‑1 (GLP‑1) receptor agonist formulated as an oral tablet taken once daily. The recommended starting dose is 0.8 mg once a day; after at least 30 days, the dose should be increased to 2.5 mg. Following another minimum 30‑day period, the dose is escalated to 5.5 mg once daily, with the option to further titrate to 9 mg, 14.5 mg or 17.2 mg at intervals of at least 30 days at each step based on individual response and tolerability. This stepwise titration is designed to optimise efficacy while managing gastrointestinal and other treatment‑related side effects commonly seen with GLP‑1 therapies

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