February 5, 2026
Finance

Hims & Hers Introduces Compounded Semaglutide Pill, Prompting Legal Threats from Novo Nordisk

Hims & Hers expands its weight loss treatment offerings with a new compounded semaglutide pill, while Novo Nordisk warns of potential legal repercussions

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Summary

Hims & Hers Health Inc. has launched a compounded semaglutide pill as part of its weight loss specialty portfolio, providing customers with a more affordable option. The new formulation is designed to protect the active ingredient during digestion and enhance its absorption. In response, pharmaceutical giant Novo Nordisk has issued a statement denouncing the pill as an unapproved product posing patient safety risks and has threatened legal action. The dispute follows earlier tensions after Novo Nordisk ended its collaboration with Hims & Hers in 2025, impacting Hims & Hers’ stock performance.

Key Points

Hims & Hers introduced a compounded semaglutide pill incorporating the same active ingredient as Novo Nordisk’s FDA-approved Wegovy, aimed at expanding affordable weight loss treatment options.
The compounded pill is designed to protect the active ingredient during digestion and enhance absorption, while Hims & Hers expanded its facilities to support advanced compounding and R&D activities.
Novo Nordisk condemned the product as an unapproved and potentially unsafe knockoff, threatening legal and regulatory actions and emphasizing its proprietary formulation and full FDA approval for Wegovy.
The announcement intensifies existing tensions following Novo Nordisk’s discontinuation of collaboration with Hims & Hers in 2025, which previously caused a significant decline in Hims & Hers stock price.

Hims & Hers Health Inc. (NYSE:HIMS) took a significant step forward in expanding its weight management offerings by introducing a compounded semaglutide pill, which contains the same active molecule as Novo Nordisk A/S’ (NYSE:NVO) FDA-approved weight loss drug, Wegovy. The company announced the availability of this new treatment starting Thursday, featuring an introductory pricing model of $49 for the first month, targeting eligible customers seeking affordable options for weight loss medication.

The newly formulated compounded semaglutide pill is engineered to protect the integrity of the active ingredient as it passes through the digestive system, thereby supporting improved absorption in the body. This innovation aligns with Hims & Hers’ strategic growth in specialty pharmacy services. Further bolstering their operational capacity, the firm has doubled its physical footprint in 2025 to over one million square feet. This expanded space incorporates advanced pharmacy capabilities, laboratory testing facilities, and research and development areas, signaling a robust investment in the infrastructure necessary to support complex pharmaceutical compounding.

Hims & Hers has stated that its compounded semaglutide offerings comply with all applicable federal and state regulations governing drug compounding. Compounded medications differ from mass-produced pharmaceuticals, being custom-prepared by pharmacies to meet individual patient needs. The company positions its compounded semaglutide as a legal, accessible alternative for patients who might find the cost or availability of FDA-approved Wegovy challenging.

However, shortly after Hims & Hers’ product announcement, Novo Nordisk issued a strong public response. The Danish pharmaceutical leader criticized the new pill as an "unapproved, inauthentic, and untested knockoff" of semaglutide. Novo Nordisk argued that Hims & Hers’ approach constitutes illegal mass compounding with significant risks to patient safety, emphasizing that only Novo Nordisk produces an FDA-approved oral formulation of semaglutide known as Wegovy.

Central to Novo Nordisk’s contention is the use of proprietary SNAC technology in the official Wegovy pill, which facilitates effective absorption of semaglutide when administered orally. Novo Nordisk highlighted that its product is available in all prescribed doses and maintains a consistent supply. In contrast, compounded semaglutide lacks FDA approval and may contain impurities, unverified additives, or doses that have not undergone rigorous clinical testing.

The pharmaceutical company warned that Hims & Hers’ marketing of compounded semaglutide represents "illegal mass compounding" and falsely suggests personalization while risking patient welfare. Novo Nordisk also referenced prior warnings from the U.S. Food and Drug Administration (FDA) regarding deceptive advertising related to GLP-1 products by Hims & Hers.

This legal dispute follows developments earlier in 2025 when Hims & Hers’ shares plummeted nearly 30% after Novo Nordisk ceased collaboration with the company for direct distribution access to Wegovy. Regulatory and legal scrutiny has since surrounded Hims & Hers’ business practices concerning the marketing and sale of compounded GLP-1 medications.

As of Thursday’s market close, Hims & Hers Health’s stock declined by approximately 1.85% to $23.94, while Novo Nordisk shares dropped 5.98% to $44.37, reflecting investor reactions to the ongoing conflict and broader concerns about future prospects amid the contentious environment.

In parallel to this dispute, Hims & Hers continues to emphasize the role of compounded medications in expanding treatment accessibility, leveraging its expanded facilities and operational capabilities. The company’s strategic push into compounded drug development represents an attempt to capture market share in weight management by offering more accessible pricing, albeit with regulatory and legal hurdles.

The contrasting positions of Hims & Hers and Novo Nordisk underscore the complex intersection between pharmaceutical innovation, regulatory compliance, and competitive market dynamics in the burgeoning field of GLP-1 weight loss therapies.

Risks
  • Novo Nordisk’s legal and regulatory threats could result in restrictions or penalties against Hims & Hers’ compounded semaglutide offering.
  • Compounded semaglutide lacks FDA approval and may carry risks such as impurities or untested dosages, raising patient safety concerns.
  • Hims & Hers faces reputational risks and potential regulatory scrutiny over past and current marketing practices for GLP-1 related products.
  • Market uncertainty and conflict between the companies may impact investor confidence and share price volatility for both Hims & Hers and Novo Nordisk.
Disclosure
Education only / not financial advice
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