3 Trends Shaping the GLP-1 Landscape
•February 13, 2026
0
Companies Mentioned
Why It Matters
Regulatory clarity and rapid oral launches are accelerating market consolidation, while emerging efficacy and safety data will influence payer coverage and clinician adoption.
Key Takeaways
- •FDA removed suicide warnings from Saxenda, Wegovy, Zepbound
- •Compounded GLP-1 pills face strict FDA marketing restrictions
- •Oral Wegovy set record fastest U.S. drug launch
- •Compounded GLP-1s account for ~30% U.S. market share
- •Bariatric surgery outperforms GLP-1s on A1C and weight
Pulse Analysis
The FDA’s recent decision to eliminate suicidal‑ideation warnings from three high‑profile GLP‑1 agents reflects a growing confidence in the safety profile of this drug class, yet the agency’s crackdown on compounded formulations underscores an ongoing tension between innovation and regulatory oversight. By limiting the marketing of non‑approved compounded versions, regulators aim to protect patients from substandard products while preserving the commercial advantage of brand‑name manufacturers, a balance that will shape future litigation and market entry strategies.
Novo Nordisk’s oral Wegovy has shattered launch benchmarks, achieving over 26,000 prescriptions within three weeks and earning the label of the fastest U.S. drug debut. This momentum fuels a broader shift toward oral GLP‑1 options, intensifying competition with upcoming entrants such as Eli Lilly’s oral candidate, forforglipron. Meanwhile, compounded GLP‑1s already command roughly 30% of the U.S. market, prompting a wave of lawsuits and heightened FDA scrutiny that could curtail their growth and reallocate market share toward fully approved oral and injectable products.
Clinical evidence is also evolving. A recent Annals of Internal Medicine study found bariatric surgery delivers superior A1C reduction and weight loss compared with GLP‑1 therapy, even as GLP‑1 prescriptions jumped 132.6% from 2022 to 2023. Adoption patterns reveal endocrinologists leading prescriptions, while cardiologists and pediatricians lag behind. Additional safety signals, including an increased risk of nonscarring hair loss, add complexity to treatment decisions. Together, these dynamics signal a maturing GLP‑1 landscape where regulatory actions, launch velocity, and emerging efficacy data will dictate the next wave of investment and therapeutic positioning.
3 trends shaping the GLP-1 landscape
GLP-1 therapies continue to reshape chronic disease treatment, triggering regulatory updates, new clinical findings and intensifying competition across the pharmaceutical market.
Here are three trends driving the drug class forward:
1. Regulatory momentum accelerates
On Jan. 13, the FDA directed drugmakers to remove suicidal ideation warnings from three GLP-1s — Saxenda, Wegovy and Zepbound — after reviewing 91 clinical trials and a retrospective cohort of 2.2 million patients. The agency found no elevated risk of psychiatric events, including among patients with obesity or Type 2 diabetes.
Meanwhile, the FDA and HHS cracked down on compounded GLP-1 pills. Telehealth firm Hims & Hers launched a compounded version of Novo Nordisk’s oral Wegovy Feb. 5, but reversed course two days later following legal threats from Novo Nordisk and a Justice Department referral. The FDA said it will restrict marketing of compounded GLP-1s as similar alternatives to approved drugs.
2. Oral GLP-1s drive growth — and legal risk
Novo Nordisk’s once-daily oral Wegovy could be the fastest pharmaceutical launch in U.S. history. IQVIA data show 26,100 prescriptions were written in the drug’s third week on the market, a 42% increase from the prior week. Healthcare investment banker Leerink Partners called it “the fastest drug launch ever.”
The rapid uptake comes amid escalating tensions between brand-name manufacturers and companies marketing compounded versions. In 2025, compounded GLP-1s made up nearly 30% of the U.S. market, prompting lawsuits and tighter FDA oversight. The next disruption could arrive in March, when the FDA is expected to decide on Eli Lilly’s competing oral GLP-1, orforglipron.
3. Evidence and adoption trends shift
A Jan. 20 study published in Annals of Internal Medicine found bariatric surgery outperformed GLP-1s in reducing A1C and weight among patients with Type 2 diabetes, regardless of social vulnerability. As GLP-1 prescriptions increased 132.6% between 2022 and 2023, bariatric surgery volumes declined 25.6%. Vizient projects an additional 15% decline in surgery volumes by 2034.
Prescribing trends are also shifting. In 2025, more than 500,000 clinicians wrote GLP-1 prescriptions, led by endocrinologists. Cardiologists and pediatricians were among the slowest adopters, according to IQVIA.
A separate cohort study of 550,000 patients, published Feb. 9 and conducted by George Washington University, found GLP-1 users had higher odds of nonscarring hair loss — including telogen effluvium and androgenetic alopecia — compared to matched controls. The risk appeared independent of weight loss and other clinical variables.
The post 3 trends shaping the GLP-1 landscape appeared first on Becker's Hospital Review | Healthcare News & Analysis.
0
Comments
Want to join the conversation?
Loading comments...