In the world of incretin therapy, there are two important updates for your clinical practice. Staying informed about dosing updates and FDA actions remains essential in this dynamic GLP-1/GIP landscape.

First, the oral version of semaglutide (Rybelsus) now offers two dosing options. In addition to the original R1 formulation of 3, 7 and 14mg, there is now a more conservative R2 dosing formulation of 1.5, 4 and 9mg.  This lower dosing option was recently introduced to help reduce gastrointestinal side effects while maintaining efficacy and enabling smoother escalation than the original dosing strategy.

Second, Eli Lilly has launched single dose vials of tirzepatide, to provide more accessibility and pricing options for self-pay individuals who need a safe, less expensive option.  We have updated our FREE Medication PocketCards to reflect this latest information.  You can also purchase your own laminated version! 

1. Rybelsus (oral semaglutide) dosing update

Novo Nordisk’s FDA-approved oral GLP-1 therapy, Rybelsus, now comes in two formulations:

• Formulation R1 tablets: 3mg, 7mg, and 14mg

• Formulation R2 tablets: 1.5mg, 4mg, and 9?mg

Standard titration protocols:

• R1: Start at 3mg daily (days 1–30), increase to 7mg (days 31–60); thereafter, remain at 7mg or escalate to 14mg if needed.

• R2: Starting dose is 1.5mg daily for 30 days, then increase to 4 mg (days 31–60); after that, maintain 4mg or advance to 9mg based on glycemic control

See Rybelsus Package Insert for more detailed information.

Looking ahead—CV benefits expansion

A supplemental new drug application (sNDA) is under review to broaden Rybelsus’s indication to include major adverse cardiovascular events risk reduction in type 2 diabetes patients with cardiovascular or kidney disease. The FDA is expected to rule by October 2025.

2. Single vial tirzepatide (Zepbound) rollout

Eli Lilly has launched single dose vials of Zepbound (tirzepatide)—a dual GLP-1/GIP agonist approved for obesity and sleep apnea treatment—offering a more accessible and flexible self-pay option.

What’s available?

• 2.5mg and 5mg vials have been available for a while; now 7.5mg, 10mg, and even 12.5mg and 15mg single-dose vials are being offered.

• Pricing is approximately $349/month for 2.5mg, $499 for 5mg, and newly introduced higher doses cap around $499–699/month depending on dose and timing.

Why vials matter:

• Affordability: Prices are considerably lower than injector pens, which often cost around $1,000 monthly before insurance

• Accessibility: Targets self-pay patients not eligible for insurance or savings programs.

• Precision: Enables titration beyond currently approved pen doses; however, it requires self-administration via syringe, increasing complexity and risk of dosing errors.

• More info health.com.

Safety considerations:

• The FDA continues to crack down on compounded (non-FDA-approved) semaglutide and tirzepatide products due to serious safety reports tied to misdosing and sterility issues.

• Lilly, in turn, is using its vial rollout and legal action to provide safer, legitimate alternatives to compounding pharmacies.

3. Connecting the dots

4. Clinical & financial insights

• Rybelsus: Benefit from the new R2 protocol that eases GI side effects and may soon gain cardiovascular protection indications.

• Tirzepatide: Vials offer cost savings and dosage flexibility, but require extra care in administration. Safe sourcing is key

• Market impact: The FDA’s crackdown on compounding and Lilly’s legal and pricing strategies reflect a shift toward ensuring access to approved, reliable options over risky alternatives .

5. Bottom line

• Rybelsus: The new R2 dosing regimen improves tolerability while maintaining efficacy and supports potential future cardiovascular indications.

• Tirzepatide vials: A welcome, lower-cost, flexible injection option—but users must handle dosing themselves and steer clear of unsafe compounded products.

Download our FREE Medication PocketCards to reflect this latest information.  You can also purchase your own laminated version! 

Rybelsus Package Insert