What Happened to Hims Semaglutide? The Full Timeline

Hims & Hers built a fast-growing weight loss business on compounded semaglutide injections, launched in May 2024 at $199 per month ^[2], which was legal at the time because the FDA listed semaglutide as being in shortage ^[1]. That window closed in February 2025, when the FDA determined Novo Nordisk could meet or exceed nationwide demand for all doses of Wegovy and Ozempic ^[6], and mass compounding became legally restricted by May 22, 2025, with only rare case-by-case exceptions ^[5][6].

What followed was a chain of events that reshaped the company: a Super Bowl ad that drew letters from two U.S. senators, an April 2025 partnership with Novo Nordisk to sell branded Wegovy starting at $599 per month, the collapse of that partnership eight weeks later, an FDA warning letter in September 2025, an abandoned $49 compounded pill in early 2026, a Novo Nordisk lawsuit, and a deal ending the dispute in March 2026 ^{[3][5][7][8][11][12]}. The company has since shifted to selling branded GLP-1 medications, a transition that coincided with a reported loss of roughly $92 million in the first quarter of 2026 ^[13].

What was Hims & Hers selling, and why was it legal?

Hims & Hers launched its weight loss program in late 2023 and began offering compounded semaglutide injections through its platform in May 2024 ^[1][2]. Semaglutide is the active ingredient in Ozempic and Wegovy, Novo Nordisk’s diabetes and weight loss drugs ^[1][2].

Compounded drugs are custom-made alternatives to brand-name drugs, designed to meet a specific patient’s needs ^[1]. The FDA does not review compounded products for safety or effectiveness ^[1]. Federal rules permit compounding when a brand-name drug is in shortage, as long as pharmacies meet specific regulatory requirements ^[1][2]. While semaglutide was on the FDA’s shortage list, pharmacies could legally make and distribute compounded copies ^[4]. As of February 2025 reporting, the FDA still listed semaglutide as in shortage ^[1].

Demand was strong. Hims & Hers shares rose more than 170% in 2024, and the company’s market cap reached about $9.5 billion on February 7, 2025 ^[1].

How much did it cost compared with Ozempic and Wegovy?

At launch in May 2024, Hims & Hers charged $199 per month for compounded semaglutide injections ^[2]. As of February 2025, the company still sold compounded semaglutide for under $200 a month ^[1].

Brand-name versions cost far more without insurance at the time. News coverage from early 2025 put Ozempic at almost $1,000 per month and Wegovy at $1,349 per month, with both drugs running around $1,000 a month without insurance ^[1][2].

Date	Product	Reported price
May 2024	Compounded semaglutide injections (Hims & Hers)	$199 per month [2]
February 2025	Compounded semaglutide (Hims & Hers)	Under $200 per month [1]
Early 2025	Ozempic (brand, no insurance)	Almost $1,000 per month [1][2]
Early 2025	Wegovy (brand, no insurance)	$1,349 per month [2]
April 2025	Wegovy via LifeMD or Ro (NovoCare)	$499 per month [3][4]
April 2025	Hims & Hers Wegovy plus membership bundle	Starting at $599 per month [3][4]

These are dated snapshots from news coverage, not current prices. Anyone comparing options today should check hims.com and the other platforms directly for current pricing.

What was the Super Bowl ad controversy about?

In late January 2025, Hims & Hers released a 60-second ad called “Sick of the System,” scheduled to run during the third quarter of Super Bowl LIX on Fox ^[1][2]. Set to Childish Gambino’s “This Is America,” the spot depicted people eating unhealthy foods ^[2]. It attacked what it called a “$160 billion” weight loss industry and said existing medications are “priced for profits, not patients” ^[1][2]. It cited figures including 74% of Americans being overweight and more than 500,000 obesity-related deaths per year ^[2].

On Friday, February 7, 2025, Sens. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) wrote to the FDA, saying the ad “risks misleading patients” ^[1][2]. Their letter stated: “Nowhere in this promotion is there any side effect disclosure, risk, or safety information as would be typically required in a pharmaceutical advertisement” ^[1][2]. They also noted that for only three seconds of the minute-long commercial, small, barely legible on-screen text stated the products are not FDA-approved ^[1]. The senators did not name Hims & Hers in the letter, but they referenced imagery of an injection pen with distinctive characteristics of an existing brand-name medication ^[1].

The Partnership for Safe Medicines, whose executive director is Shabbir Imber Safdar, also wrote to the FDA and asked Fox not to run the spot ^[2]. PhRMA, which represents Novo Nordisk and Eli Lilly, is a member of the Partnership for Safe Medicines ^[2].

Not everyone agreed the ad broke rules. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, called it “help-seeking” advertising that encourages viewers to consult a healthcare provider and therefore does not require side effect information ^[1]. Hims & Hers said, “We are complying with existing law” ^[1][2]. The senators said they believed the FDA may have the authority to take enforcement action and planned to introduce legislation to address the regulatory loophole they believed the ad exploited ^[1].

Did the FDA end the semaglutide shortage?

Yes. In February 2025, the FDA announced that Novo Nordisk could fully meet or exceed nationwide demand for all doses of Wegovy and Ozempic, declaring an end to the shortage ^[6].

That determination carried deadlines. Larger outsourcing facilities that make compounded drugs were given until May 22, 2025 to stop production, and smaller compounding pharmacies were told to stop immediately ^[6]. After the shortage ended, compounding copies of the drug was legally restricted, with rare exceptions allowed case by case when medically necessary for a specific patient, such as an allergy to an ingredient or an inability to swallow a pill ^[5].

In late April 2025, a federal court in Texas rejected a legal challenge by compounding pharmacies to the FDA’s no-shortage determination ^[4].

What was the Novo Nordisk partnership?

On April 29, 2025, Novo Nordisk announced collaborations with Hims & Hers, LifeMD, and Ro to sell authentic Wegovy through its direct-to-patient program, NovoCare Pharmacy ^[3][4]. Under NovoCare, eligible self-pay patients, meaning those who are uninsured or have commercial insurance without obesity-drug coverage, could get all Wegovy doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg) for $499 per month ^[3].

LifeMD and Ro matched the $499 price, while Hims & Hers offered a bundle combining Wegovy with a membership including 24/7 care, clinical support, and nutrition guidance, starting at $599 per month ^[3][4]. Shipments were fulfilled through CenterWell Pharmacy ^[3].

The market liked the deal on announcement day: Hims & Hers shares rose more than 20%, LifeMD rose nearly 30%, and Novo Nordisk rose about 4% in morning trading ^[4]. Novo’s Dave Moore, executive vice president of U.S. operations, said patients “deserve to get the real thing” ^[3][4]. Hims & Hers CEO Andrew Dudum called the collaboration “the first step” toward a shared vision of consumer-centered healthcare ^[3].

Why did Novo Nordisk terminate the deal after only two months?

On June 23, 2025, Novo Nordisk terminated the collaboration, less than two months after it launched ^[5][6]. Novo alleged that Hims & Hers had “failed to adhere to the law which prohibits mass sales of compounded drugs” under a “false guise” of personalization, and accused the company of “deceptive” marketing that put patient safety at risk ^[5][6].

Hims & Hers shares closed more than 34% lower that day, while Novo Nordisk shares closed down more than 5% ^[5]. Novo said it would incur no termination fees because the deal ran through a third party that manages its direct-to-consumer pharmacy ^[5].

Novo also said it had conducted an investigation finding that the active pharmaceutical ingredients in knock-off drugs sold by telehealth entities and compounding pharmacies were manufactured by foreign suppliers in China, and it cited an April 2025 Brookings Institution report finding that a large share of those suppliers were never inspected by the FDA and that many that were inspected had drug quality assurance violations ^[5][6].

Dudum responded that Novo Nordisk was “misleading the public.” He said Novo’s commercial team had increasingly pressured Hims & Hers to steer patients to Wegovy regardless of clinical fit, and that the company refused “anticompetitive demands” that would infringe on the independent decision-making of providers ^[5][6]. He said Hims & Hers would continue offering a range of treatments, including Wegovy ^[5].

A Citi analyst, Daniel Grosslight, wrote that the termination raised Hims & Hers’ legal risk “substantially” ^[5]. Separately, in May 2025, the FDA had published concerns about unapproved GLP-1 drugs used for weight loss ^[6].

What did the FDA warning letter say?

On September 9, 2025, the FDA sent a warning letter (letter number 716825) to Hims & Hers Health, Inc. dba Hers, addressed to CEO Andrew Dudum ^[7]. The letter concerned website content at forhers.com that the FDA reviewed in August 2025 ^[7].

The FDA cited two website claims about compounded semaglutide products: “Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy” and “Clinically proven ingredients” ^[7]. The agency said these claims imply the products are the same as an FDA-approved product when they are not, because compounded drug products are not FDA-approved, making the claims false or misleading and the products misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act ^[7].

The letter gave the company 15 working days to respond in writing to the Office of Compounding Quality and Compliance within the FDA’s Center for Drug Evaluation and Research, describing steps taken to address the violations ^[7]. The FDA warned that failure to adequately address the violations could result in legal action without further notice, including seizure and injunction ^[7]. The letter was signed by George Tidmarsh, M.D., Ph.D., Director of the Center for Drug Evaluation and Research ^[7].

What happened with the $49 compounded pill?

In early 2026, the conflict escalated. On February 9, 2026, Reuters reported that Hims & Hers abandoned a $49 weight-loss pill and that Novo Nordisk shares rose ^[17]. Healthline’s coverage described the FDA as blocking the Hims & Hers $49 compounded Wegovy pill and covered the Novo Nordisk lawsuit ^[8]. Endpoints News reported that U.S. officials called for a Department of Justice investigation of Hims & Hers over GLP-1 drugs ^[9].

The same day, February 9, 2026, Novo Nordisk issued a company statement titled “Novo Nordisk takes legal action against Hims & Hers to protect patients from unsafe knock-off Wegovy and Ozempic” ^[10].

How did the Novo Nordisk dispute end?

On March 9, 2026, CNBC reported that Novo Nordisk ended legal proceedings against Hims & Hers over compounded weight loss drugs ^[11]. The same day, STAT reported that Novo Nordisk and Hims & Hers reached a deal ending their dispute over Wegovy sales ^[12].

What does Hims & Hers sell for weight loss now?

The company has shifted toward branded GLP-1 medications. Fierce Healthcare reported that Hims & Hers posted a loss of roughly $92 million in the first quarter of 2026 as it shifted to branded GLP-1 drugs ^[13]. The company has also published its second quarter 2026 financial results on its investor site ^[14], and it has announced plans to acquire Eucalyptus for $1.15 billion ^[15].

What any individual patient can be prescribed, and at what price today, depends on current offerings on hims.com and on a licensed clinician’s evaluation. The prices in this timeline are historical snapshots, not current rates.

Is Hims & Hers still facing other federal matters?

Yes. On July 29, 2026, CNBC reported that the FTC sued Hims & Hers and that the stock fell ^[19]. A law firm client alert described the FTC and states as suing over deceptive health data sharing and subscription billing practices ^[18]. One report on the FTC’s case alleged that Hims sent health data to TikTok ^[21]. Commentary coverage framed the FTC case as targeting the company’s growth model ^[22].

These are allegations, not findings. Hims & Hers issued a public response to the FTC lawsuit through its investor news release ^[20].

Is compounded semaglutide still legal anywhere?

Compounded drugs receive no FDA review for safety, effectiveness, or quality ^[1][7]. After the shortage ended, compounding copies of semaglutide was legally restricted, but it remains legal on a case-by-case basis when a prescriber determines it is medically necessary for a specific patient, such as when the patient is allergic to an ingredient in the branded drug or cannot swallow a pill ^[5].

That is a clinical judgment for a licensed prescriber, not something a patient can obtain on request. Novo Nordisk’s position was that Hims & Hers used “personalization” as a false guise for mass sales ^[5], while Hims & Hers maintained that lawful, personalized compounded care serves patients with complex needs ^[6].

What should someone shopping for GLP-1 drugs know today?

A few points from this timeline hold regardless of platform. Compounded drugs are not FDA-approved and get no FDA review ^[1][7]. Branded Wegovy has a self-pay pathway through NovoCare Pharmacy, with eligibility limited to uninsured patients or those with commercial insurance that does not cover obesity medications ^[3]. LifeMD and Ro also sold branded Wegovy at the $499 NovoCare price as of April 2025 ^[3][4].

Prices change. The $199 compounded injection price is from May 2024 ^[2], the $499 and $599 figures are from April 2025 ^[3][4], and none of them should be treated as current. Check hims.com and other platforms directly, and route questions about which medication is appropriate to a licensed clinician.

Sources

1. CNBC. Hims & Hers faces lawmaker scrutiny over ‘misleading’ Super Bowl ad. February 7, 2025.
2. Adweek. Hims & Hers Super Bowl Ad Under Fire From Trade Group, Senators.
3. Endocrine and Metabolic Physicians Resource (EMPR). Novo Nordisk Partners With Telehealth Platforms to Expand Wegovy Access.
4. BioPharma Dive. Novo partners with telehealth companies in move to expand Wegovy market.
5. CNBC. Novo Nordisk ends Wegovy deal with Hims & Hers. June 23, 2025.
6. MobiHealthNews. Novo Nordisk terminates contract with Hims & Hers alleging deceptive practices. June 24, 2025.
7. US Food and Drug Administration. Warning letter: Hims & Hers Health, Inc. dba Hers. September 9, 2025.
8. Healthline. FDA Blocks Hims & Hers $49 Compounded Wegovy Pill: What to Know.
9. Endpoints News. US calls for DOJ investigation of Hims over GLP-1 drugs. February 6, 2026.
10. Novo Nordisk. Novo Nordisk takes legal action against Hims & Hers to protect patients from unsafe, knock-off Wegovy and Ozempic. February 9, 2026.
11. CNBC. Novo Nordisk ends legal proceedings against Hims & Hers. March 9, 2026.
12. STAT News. Novo Nordisk, Hims reach deal to end bitter dispute over Wegovy sales. March 9, 2026.
13. Fierce Healthcare. Hims & Hers posts $92M loss in Q1 as it shifts to branded GLP-1 medications. May 12, 2026.
14. Hims & Hers Health, Inc. Hims & Hers Health, Inc. Reports Second Quarter 2026 Financial Results.
15. MobiHealthNews. Hims & Hers plans to acquire Eucalyptus for $1.15B. February 19, 2026.
16. US Securities and Exchange Commission. Hims & Hers Health, Inc. annual report (Form 10-K) for fiscal year 2025.
17. Reuters. Novo Nordisk sues Hims after $49 weight-loss pill sparks FDA backlash. February 9, 2026.
18. Shumaker, Loop & Kendrick, LLP. Client Alert: FTC and States Sue Hims & Hers Over Deceptive Health Data Sharing and Subscription Billing Practices.
19. CNBC. FTC sues Hims and Hers, stock falls. July 29, 2026.
20. Hims & Hers Health, Inc. Hims & Hers Responds to FTC Lawsuit.
21. Unfiltered Ledger. Hims Sent Health Data to TikTok, FTC Says.
22. AInvest. The FTC Didn’t Just Sue Hims & Hers — It Pointed at How the Company Grows.