FDA Approves Monthly KwikPen Option for Tirzepatide in Chronic Weight Management

The FDA has approved a label expansion for tirzepatide (Zepbound; Eli Lilly), allowing use of a 4-dose, single-patient-use KwikPen that delivers a full month of treatment in 1 device for chronic weight management, the manufacturer announced today.¹

Eli Lilly said the new option expands treatment options, enabling patients and clinicians to choose the one that best fits individual needs, preferences, and circumstances. In particular, patients with a valid prescription who opt for self-pay through LillyDirect can receive all tirzepatide doses in either the KwikPen or single-dose vial starting at $299 per month for the 2.5 mg dose.

Tirzepatide was the most prescribed weight management medication in 2025, supported by a strong efficacy profile. In the 72-week phase 3 SURMOUNT-1 clinical trial (NCT04184622) of adults without diabetes, average weight loss with tirzepatide was 15.0% (34 lb) with 5 mg, 19.5% (44 lb) with 10 mg, and 20.9% (48 lb) with 15 mg, compared with 3.1% with placebo.

Similarly, in the 72-week, multicenter, randomized, open-label, phase 3b SURMOUNT-5 trial (NCT05822830) comparing the efficacy and safety of tirzepatide with injectable semaglutide (Wegovy; Novo Nordisk), patients receiving tirzepatide lost an average of 50 lb (20.2% weight loss), whereas those on semaglutide lost an average of 33 lb (13.7% weight loss).

FDA Approval Timeline

After initially receiving approval in May 2022 as Mounjaro to treat adults with type 2 diabetes, tirzepatide was approved in November 2023 under the name Zepbound for chronic weight management.² This decision was supported by data from the SURMOUNT-1 and -2 (NCT04657003) trials and made tirzepatide the second diabetes drug to receive a weight management indication, following semaglutide.

Zepbound is available in 2.5-, 5-, 7.5-, 10-, 12.5-, and 15-mg doses. The recommended maintenance doses for weight reduction and long-term management are 5, 10, or 15 mg administered subcutaneously once per week.¹

In December 2024, tirzepatide became the first and only prescription drug approved for moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used alongside a reduced-calorie diet and increased physical activity.³ The approval was based on findings from the phase 3 SURMOUNT-OSA trials (NCT05412004) evaluating 10- or 15-mg tirzepatide doses vs placebo in patients with or without positive airway pressure (PAP) therapy.

Among adults receiving PAP therapy, tirzepatide resulted in 29 fewer breathing disruptions per hour compared with 6 per hour with placebo. Meanwhile, adults not using PAP had 25 fewer breathing disruptions per hour on tirzepatide vs 5 per hour with placebo. Depending on PAP use, mean weight loss ranged from 45 to 50 lb with tirzepatide vs 4 to 6 lb with placebo.

“Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity…marking a critical step forward in reducing the burden of this disease and its interconnected health challenges,” Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA, said in a news release.⁴

Looking ahead, tirzepatide is also being studied in heart failure with preserved ejection fraction.³ Results from the phase 3 SUMMIT trial (NCT04847557), presented at the 2024 American Heart Association Scientific Sessions, showed a 38% reduction in the risk of cardiovascular death or worsening heart failure.

References

1. Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen. News release. Eli Lilly. February 23, 2026. Accessed February 23, 2026. https://investor.lilly.com/news-releases/news-release-details/zepbound-tirzepatide-most-prescribed-weight-management
2. Joszt L. FDA approves diabetes drug tirzepatide for chronic weight management. AJMC^®. November 8, 2023. Accessed February 23, 2026. https://www.ajmc.com/view/fda-approves-diabetes-drug-tirzepatide-for-chronic-weight-management
3. Joszt L. Weight loss drug tirzepatide now approved for sleep apnea in adults with obesity. AJMC. December 20, 2024. Accessed February 23, 2026. https://www.ajmc.com/view/weight-loss-drug-tirzepatide-now-approved-for-sleep-apnea-in-adults-with-obesity
4. FDA approves Zepbound (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity. News release. Eli Lilly. December 20, 2024. Accessed February 23, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription