Direct-to-consumer marketing by telehealth platforms and compounding pharmacies has fueled demand for compounded GLP-1 therapies, promoted as affordable and personalized alternatives. In response, branded manufacturers such as Lilly and Novo Nordisk have launched consumer-facing initiatives to reinforce the safety, efficacy, and regulatory oversight of FDA-approved products. Lilly promotes its LillyDirect^® cash-pay program and has partnered with Ro to expand access. Novo Nordisk offers a similar cash-pay option through GoodRx and NovoCare^® Pharmacy, which briefly collaborated with Hims and Hers before ending the partnership due to conflicting compounded offerings. Novo also launched its “Check Before You Inject” campaign to educate patients on the risks associated with unregulated formulations. Peer-to-peer discussions have further fueled interest in “microdosing,” with compounded vials offering greater dosing flexibility than fixed-dose pens.

A key factor sustaining the compounded GLP-1 market post-shortage is the widespread use of additives. Over 80% of compounded semaglutide and tirzepatide prescriptions now include supplemental ingredients such as B vitamins (B6, B12, B3) or levocarnitine. These additions are often positioned as enhancements to energy metabolism or weight loss support, and may serve as a rationale for continued compounding despite the FDA’s resolution of supply shortages.

Interestingly, the prevalence of additives has increased in parallel with the end of the shortage period, suggesting that some compounders may be utilizing these modifications to differentiate their products or navigate regulatory ambiguity. However, this trend raises important concerns. Additives can alter pharmacokinetics, potentially impacting the efficacy of the active molecule. Moreover, safety risks are emerging, particularly when compounded formulations include substances not found in FDA-approved versions¹.

Recent regulatory guidance underscores the risks associated with compounding GLP-1s using additives such as B12 or glycine. The FDA has clarified that pharmacies may not rely on additive inclusion alone to justify a “significant difference” from approved products. Such differences must be medically necessary and documented for individual patients. Prescribers who authorize compounded combinations without appropriate clinical justification may face increased scrutiny or liability under federal and state law².

As compounding pharmacies continue to develop around additive combinations, pharmaceutical stakeholders must closely monitor the clinical and regulatory implications. The evolving landscape underscores the need for clear enforcement, robust pharmacovigilance, and strategic engagement to protect patient safety and preserve brand integrity.

Patient Behavior and Adherence Trends in Compounded vs. Branded GLP-1 Therapies

Patient behavior reveals a stark contrast between compounded and branded GLP-1 therapies, particularly in terms of adherence and persistency. By month three, a clear separation emerges, with compounded users demonstrating significantly lower continuation rates. This drop-off may be attributed to a subset of patients—often impulse buyers—seeking rapid weight loss rather than committing to long-term therapeutic regimens. Additionally, compounded products are typically paid for out-of-pocket, which can be more financially prohibitive than branded therapies covered under commercial insurance plans.

Despite the growing presence of compounded GLP-1s, switching to branded alternatives remains rare. In a snapshot of monthly transitions, only 2 percent of compounded patients move to branded products. Among anti-obesity medication (AOM) users, the switch rate is just 2 percent, while type 2 diabetes (T2D) patients show a slightly higher rate at 7 percent, likely due to broader payer coverage for branded diabetes therapies.

For the small cohort of AOM patients who do switch, tirzepatide is the most common agent, and nearly half opt to pay cash for Zepbound, often through LillyDirect’s direct-to-consumer platform. The remaining patients rely on commercial insurance to access branded options. These patterns suggest that cost remains a significant barrier to switching, and when patients do transition, they gravitate toward accessible cash-pay programs or insurance-supported channels.

Understanding these behavioral dynamics is critical for pharmaceutical stakeholders assessing market retention, pricing strategies, and patient engagement models in the evolving GLP-1 landscape.

Strategic Imperatives in a Shifting GLP-1 Market

The GLP-1 market has exposed how quickly alternative channels like telehealth platforms and compounding pharmacies can scale and disrupt traditional brand management. Lessons learned are not limited to only obesity treatment. To remain competitive, manufacturers across the industry must respond with precision, building internal solutions that meet patient expectations while protecting brand integrity.

• Establish direct-to-patient programs within the manufacturer’s ecosystem to compete with external compounding and telehealth offerings. These channels should prioritize affordability, convenience, and education to attract and retain patients. Any such program must be vetted with legal and regulatory guidance.
• Analyze the behavior of compounded drug users to understand their motivations, expectations, and barriers. Use these insights to craft targeted messaging and conversion strategies that guide patients toward branded therapies.
• Position your brand around unmet needs that compounded products cannot reliably address—such as clinical consistency, long-term safety, and regulatory assurance. This drives provider confidence and accelerates adoption.
• Address cost head-on by offering transparent cash-pay options, affordability programs, and payer partnerships. Reducing financial friction is essential to converting patients who might otherwise choose compounded alternatives.
• Deploy a multi-channel engagement strategy that blends personal promotion, nonpersonal outreach, and consumer-driven campaigns. Ensure messaging is consistent across platforms, tailored to both patients and providers, and compliant to fair balance requirements.

Manufacturers that embrace these tactics and build strategies around patient-centric, channel-diverse models will be best positioned to succeed in today’s competitive therapeutic landscape. Reach out to IQVIA to learn more about how to build successful strategies like those seen in the GLP-1s.

References:

1. FDA Compliance Alert for Weight Management Providers: Compounded GLP-1s with Additives - Montgomery Purdue.
2. FDA Compliance Alert for Weight Management Providers: Compounded GLP-1s with Additives - Montgomery Purdue.