Hims & Hers built a brand on one big promise: make healthcare simpler, cheaper, and easier to access. But its latest move in the weight-loss gold rush shows the risk of trying to “hack” a blockbuster drug market with a shortcut.
This week, Hims announced plans to sell a compounded oral semaglutide pill for $49—positioned as a lower-cost alternative to Novo Nordisk’s newly launched Wegovy pill. Within two days, Hims backed off after the FDA commissioner, Marty Makary, publicly described the offering (and similar products) as “illegal copycats.” Novo Nordisk then escalated further, filing a lawsuit against Hims alleging patent infringement tied to its injectable weight-loss drugs.
The result: a high-profile retreat that’s now accelerating pressure on the entire “compounded GLP-1” ecosystem.
Why this fight is happening now
For the last couple of years, compounded versions of GLP-1 weight-loss drugs exploded in popularity during periods of shortages. When brand-name supply was tight, compounding pharmacies were temporarily able to fill a gap—often by offering customized doses or formulations.
But the landscape is shifting fast:
- Brand-name supply has improved
- Novo Nordisk and Eli Lilly have moved to cut prices more aggressively
- Regulatory scrutiny is rising
- Insurers are slowly expanding coverage, reducing the “gray market” demand
In that environment, the window for widespread compounded GLP-1s narrows—and the appetite for bold, borderline offerings collapses even faster.
Why the “pill” idea was especially risky
Injectable compounded GLP-1s already live in a complicated space. But an oral semaglutide pill is a different animal.
The core problem: peptides like GLP-1s are fragile, and getting them to work through the digestive system is notoriously difficult. Novo’s oral approach relies on specialized, patented absorption technology. Hims couldn’t use that.
Instead, Hims said it planned to use a liposomal delivery technique (think microscopic “bubbles” carrying the active ingredient) to help the medication absorb properly. Experts have pointed out that this kind of technology is complex, highly sensitive to manufacturing precision, and hard to standardize—especially in a “personalized compounding” context.
That complexity creates two huge hazards:
- Effectiveness risk: if the delivery isn’t precisely engineered, the pill may not reliably deliver the dose.
- Safety and oversight risk: regulators get nervous when sophisticated drug-delivery methods are used without the kind of formal approval pipeline expected for mass-market therapies.
The bigger consequence: compounding crackdowns are speeding up
Hims didn’t just trigger backlash aimed at one company. The episode is acting like a bright flare for regulators and brand-name manufacturers—highlighting what they view as a growing problem: commercial-scale compounding that looks like brand duplication, not patient-specific customization.
Analysts are increasingly blunt about where this goes:
- compounded GLP-1 volumes likely decline as branded prices fall and access improves
- enforcement and litigation pressure likely increase
- “platforms” built heavily on compounded GLP-1 revenue may face a harder path to sustained growth
Why this matters for Hims as a business
Hims has ridden a major growth wave by expanding beyond its original sexual-health franchises and leaning into weight-loss offerings—especially injectable GLP-1s.
But investors have been looking for the next growth engine as forecasts show the company’s growth rate slowing in coming years. The oral-pill announcement looked like it was meant to be that next engine: a big new market of people who want GLP-1 results without injections.
Now, that plan is in doubt—and the market has punished the uncertainty. Hims shares have fallen sharply since the pill headlines, and the company is left needing to show it can keep expanding without leaning on products that regulators and patent holders can squeeze.
The bottom line
Hims tried to turn the hottest category in healthcare into an affordability win—and instead ran straight into the hard wall of drug-delivery science, patent reality, and regulatory limits.
This episode also sends a clear signal to the broader market: the easy era of “compounded GLP-1 growth hacks” is ending. In the next phase, the winners won’t be the companies with the loudest marketing or the cheapest workaround.
