The GLP-1 therapy landscape has shifted significantly with the resolution of the tirzepatide shortage in October 2024 and the semaglutide shortage in February 2025. These shortages, driven by high demand since 2022, led to restrictions on compounding (503A: February 18 for tirzepatide, April 22 for semaglutide; 503B: March 19 and May 22, 2025, respectively), impacting access to affordable alternatives. Here’s what patients and providers need to know about their options post-shortage.

Understanding the Shortage Resolution

The FDA’s resolution of the tirzepatide shortage and semaglutide shortage has restored availability of branded drugs, but compounding restrictions have limited access to lower-cost alternatives. This shift has prompted patients and providers to explore their options carefully.

Patient and Provider Options

Branded Tirzepatide (Mounjaro/Zepbound)
- Pros:
  - FDA-approved for type 2 diabetes (Mounjaro) and obesity (Zepbound).
  - Achieves 15-22.5% weight loss (up to 33-46 lbs over 52 weeks).
  - Dual GIP/GLP-1 receptor agonist enhances insulin release, slows gastric emptying, and reduces appetite.
  - Widely available post-shortage.
- Cons:
  - High cost (~$1,000/month without insurance).
  - Potential insurance coverage issues.
  - Gastrointestinal side effects (nausea, diarrhea) common during dose escalation.
  - Eli Lilly’s legal actions against compounding pharmacies may limit alternatives.
Branded Semaglutide (Ozempic/Wegovy)
- Pros:
  - FDA-approved for type 2 diabetes (Ozempic) and obesity (Wegovy).
  - Achieves 15-17% weight loss (up to 22-33 lbs over 52 weeks).
  - GLP-1 receptor agonist with cardioprotective benefits.
  - Now widely available, with Novo Nordisk shipping all doses regularly.
- Cons:
  - High cost (~$1,000/month without insurance).
  - Potential coverage challenges (e.g., patients losing eligibility after weight loss).
  - Gastrointestinal side effects (nausea in 10-20% of patients).
  - Risk of misuse reported in FAERS data (2018-2022).

What’s Next for GLP-1 Therapy?

The resolution of shortages has shifted the GLP-1 landscape, but high costs and side effects of branded drugs highlight the need for alternative approaches. Providers and patients may benefit from exploring other GLP-1 options and emerging therapies to achieve optimal outcomes.

Learn about other GLP-1 therapies and their limitations in our next post. Join our community to stay updated on innovative solutions.

Legal Disclaimer: These statements have not been evaluated by the Food and Drug Administration (FDA). The information provided is for educational purposes only and is not intended to diagnose, treat, cure, or prevent any disease. Always consult a healthcare provider before starting any new therapy or supplement, especially if using GLP-1 therapies or managing medical conditions. STAAR LABS is not responsible for adverse effects resulting from use.