GLP-1 Access Gaps: Compounded Market Robust, Pediatric Prescribing Limited

Despite the end of nationwide shortages of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), the market for compounded GLP-1 RA alternatives remains strong, and some of these products are from pharmacies with concerning regulatory histories, according to a study published online July 17 in JAMA Health Forum. The analysis included 75 brick-and-mortar weight-loss clinics and medical spas offering compounded GLP-1 RAs located in West Virginia and Oklahoma, identified by a 'secret shopper' approach. Of those businesses, 9.3 percent reported offering oral compounded GLP-1 RA formulations and 56.0 percent reported offering compounded GLP-1 RA products combined with B vitamins.

The 75 clinics drew on 23 compounding facilities, four of which were not licensed to perform sterile compounding. One facility had received multiple warning letters from the U.S. Food and Drug Administration, and three had been subject to state-level disciplinary action. The study authors said the market did not shrink after the shortages ended as many expected, and instead has remained remarkably robust.

Access barriers also extend to pediatric patients. CHOP researchers found that only about 20% of children between 12 and 17 years old who were eligible for medication intervention at the specialty weight management clinic in Philadelphia had been given a prescription, according to findings published in the journal Pediatrics. Patients who did receive medication tended to be older teens, girls, and people whose preferred language was English; they were also more likely to have the highest BMI scores and already struggle with higher cholesterol and blood sugar levels.

The U.S. Food and Drug Administration first approved a GLP-1 daily injection medication for childhood obesity in 2020, followed by a weekly GLP-1 injection medication in 2022. In 2023, the American Academy of Pediatrics updated its childhood obesity guidelines to say that medication, as well as bariatric surgery, should be offered earlier as treatment options alongside lifestyle changes. Of the children with a GLP-1 prescription at the CHOP clinic, 60% experienced some interruption to medication treatment, with the most common issues involving cost or lack of insurance coverage. Side effects and gaps in follow-up care also caused disruptions in medication use. Many older adults are also unaware that they are about to gain access to obesity drugs through a Medicare pilot program.

GLP-1 receptor agonists have fundamentally changed the treatment landscape for obesity, according to a commentary published in Gastroenterology that updates the POWER (Practice Guide on Obesity and Weight Management, Education, and Resources) framework first published in 2017. The commentary incorporates the emerging concept of clinical obesity, which recognizes obesity as a chronic, systemic disease and highlights limitations of relying on body mass index alone to assess health risks. Obesity care is increasingly moving toward a multidisciplinary model that combines medications, endoscopic therapies, and surgery. New evidence supports endoscopic sleeve gastroplasty and other endoscopic bariatric and metabolic therapies as effective treatment options, and combining GLP-1 medications with endoscopic or surgical interventions may produce greater and more durable weight loss than either approach alone.

Currently, FDA-approved drugs for obesity include centrally acting drugs, gastrointestinal lipase inhibitors, and incretin mimetics. The incretin mimetics—GLP-1 receptor agonists such as semaglutide and liraglutide, and the dual GIP/GLP-1 receptor agonist tirzepatide—demonstrate the greatest weight loss benefits, with tirzepatide achieving reductions exceeding 20% in some patients.

Peptide therapies, including GLP-1 agonists, have emerged as a growing category in obesity treatment. Peptides are short chains of amino acids that function as signaling molecules, helping regulate appetite, insulin signaling, hormone release, fat metabolism, and tissue recovery. Unlike traditional stimulant-based weight-loss products, many peptide therapies attempt to work within existing hormonal and metabolic systems rather than simply suppressing appetite through central nervous system stimulation. Drugs such as semaglutide and tirzepatide have demonstrated substantial efficacy in weight reduction and glycemic control in appropriately selected patients.

Other developments in GLP-1 research include Corxel Pharmaceuticals reporting that CX11, its investigational oral small-molecule GLP-1 agent, yielded 11.5% weight loss by week 36 in a phase II trial of individuals with overweight or obesity. The investigational GLP-1 drug bofanglutide reduced HbA1C levels at 24 weeks in a phase IIb trial of Chinese adults with type 2 diabetes, but gastrointestinal events were common. Incretin-based therapies after bariatric surgery were associated with clinically meaningful augmented weight loss in a dose- and timing-dependent manner, according to U.S. cohort data.