FDA approves Zepbound four-dose KwikPen by Eli Lilly, delivering a month’s tirzepatide treatment in one device for obesity & OSA. Access via LillyDirect. See SURMOUNT trial data, safety information.
Written By: Pharmacally Medical News Desk
Eli Lilly and Company announced a significant advancement for Zepbound (tirzepatide), with the U.S. Food and Drug Administration (FDA) approving a label expansion for a new four-dose single-patient use KwikPen. This device delivers a full month’s treatment in one convenient pen, offering patients and healthcare providers more flexibility to match individual needs and preferences.
Enhanced Access Through LillyDirect
The KwikPen expands options alongside single-dose vials. Self-pay patients via LillyDirect can now choose either format starting at $299 per month for the 2.5 mg dose. In 2025, over 1 million patients accessed Lilly treatments through this platform, which provides at least 50% discounts compared to list prices for other GLP-1 obesity medications.
Notably, one in three new patients starting branded weight management medications opted for Zepbound self-pay vials, underscoring demand for affordable, direct access.
LillyDirect simplifies the process with home delivery and support, as shared by patient Jacob M.: “Along with diet and exercise, Zepbound has helped me make real, lasting progress. LillyDirect made getting the medicine simple.”
Proven Efficacy Backed by Clinical Trials
Zepbound, the #1 prescribed injectable obesity-management medication, activates dual GIP and GLP-1 receptors to reduce appetite and address excess weight’s root causes. It’s indicated for adults with obesity or overweight plus weight-related issues, and for moderate-to-severe obstructive sleep apnea (OSA) in obese adults always with diet and exercise.
Key trial data highlights its impact:
- SURMOUNT-1 (72 weeks): Adults on 15 mg lost 20.9% body weight (average 48 lbs from 232.8 lbs start) vs. 3.1% (7 lbs) on placebo. Doses of 5 mg, 10 mg, or 15 mg sustained losses.
- SURMOUNT-5 (72 weeks, open-label Phase 3b): Zepbound (max tolerated dose of 10 mg or 15 mg) led to 20.2% loss (50 lbs from 248.4 lbs) vs. 13.7% (33 lbs from 250 lbs) on Wegovy (semaglutide, max 1.7 mg or 2.4 mg).
Doses range from 2.5 mg (starter) to 15 mg weekly; maintenance is 5-15 mg for weight loss, 10-15 mg for OSA.
Important Safety Notes
Zepbound carries risks like thyroid tumors (monitor for neck lumps, hoarseness); avoid if history of medullary thyroid carcinoma, MEN 2, or allergies to tirzepatide. It’s not for children or cosmetic use and shouldn’t combine with other tirzepatide or GLP-1 products. The trusted KwikPen, used globally for other Lilly medications, emphasizes single-patient use to prevent infections.
For complete details on adverse reactions, warnings, precautions, and more, refer to the official Zepbound U.S. Prescribing Information.
Reference
Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen, 23 February 2026, Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen | Eli Lilly and Company
Zepbound USPI, https://pi.lilly.com/us/zepbound-uspi.pdf