Also known as: Hims, Hims & Hers, Hims & Hers Health
Company Profile
Hims & Hers Health is an American telehealth company offering prescription and over-the-counter medications and personal care products through a direct-to-consumer platform. It was founded in 2017 and expanded its services to include mental health care.
The FDA has shifted from regulatory ambiguity to coordinated enforcement against compounded oral semaglutide, culminating in a 2026 announcement of intent to take action against non-approved GLP-1 drugs. Hims & Hers Health's 2024 oral semaglutide offering marked the beginning of a broader regulatory reckoning that saw manufacturer pressure, formal shortage declarations, and warning letters targeting compounding practices.
Novo Nordisk dismissed its patent infringement lawsuit against Hims & Hers after the companies reached an agreement to sell branded Wegovy and Ozempic through the Hims platform. The settlement ends a dispute that began when Hims planned to offer a cheaper off-brand version of Wegovy.
Novo Nordisk filed a patent infringement lawsuit against Hims & Hers over compounded versions of Wegovy. The legal action follows the telehealth company's announcement of a $49 oral pill, which was withdrawn after FDA warnings.
Australian regulators confirmed counterfeit GLP-1 products contain no active ingredients, while U.S. authorities escalate enforcement against compounded weight-loss drugs as Novo Nordisk sues telehealth company Hims & Hers.
The FDA announced plans to restrict GLP-1 active pharmaceutical ingredients for compounded drugs and combat misleading advertising, following the Trump administration's launch of TrumpRx and ongoing enforcement actions against compounding pharmacies.
Online telehealth company Hims & Hers withdrew plans to offer a $49 compounded oral semaglutide pill after FDA Commissioner Marty Makary called such products "illegal copycats" and Novo Nordisk filed a patent infringement lawsuit.
FDA Commissioner Marty Makary outlined plans to expand over-the-counter drug access, crack down on unlawful GLP-1 compounding, and address the U.S. falling behind China in early-stage drug development.
GLP-1 weight loss drugs show increasing efficacy but raise concerns about excessive weight loss, side effects, and the rise of unregulated compounded versions sold online.
European regulators approved a 7.2mg "megadose" of Novo Nordisk's Wegovy involving three weekly injections. The Danish drugmaker filed suit against Hims & Hers after the telehealth company briefly launched a compounded oral semaglutide product.
Novo Nordisk secured FDA approval for oral Wegovy tablets in December 2025 and subsequently sued telehealth company Hims & Hers for patent infringement over compounded versions. The company is the only manufacturer with an FDA-approved GLP-1 weight loss pill.
