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The shortage triggers the regulatory pathway under which 503B compounding facilities can legally prepare semaglutide: when the FDA confirms a drug shortage, compounding pharmacies are permitted to produce the active pharmaceutical ingredient (API) as a sterile injectable without violating patent or exclusivity restrictions that would otherwise apply

North America retains a leading position, while Asia Pacific is projected to grow rapidly due to expanding patient populations and improved healthcare investment

They are now prescribing Semaglutide, available under different brand names for other conditions, for weight management on an off-label basis

Nimbus sold the drug to Gilead for up to $1.2 billion in 2016

PIONEER 9 was a 52-week, phase 2/3a, randomized, controlled trial to assess the efficacy, dose response, and safety of oral semaglutide monotherapy (3, 7, or 14 mg) compared with placebo and liraglutide 0.9 mg in 243 Japanese patients with type 2 diabetes uncontrolled on diet and exercise or one oral glucose-lowering drug (washed out during run-in) [52]