The approval marks an expansion of delivery options
-
The FDA has approved a new four-dose, single-patient-use KwikPen for Zepbound (tirzepatide), giving patients a full month of treatment in one device.
-
Lilly says the new pen expands patient choice, with self-pay pricing through LillyDirect starting at $299 per month for the 2.5 mg dose.
-
Zepbound remains the top-prescribed injectable obesity medication, with clinical trials showing average weight loss of up to 50 pounds.
Eli Lilly and Company has announced that the U.S. Food and Drug Administration has approved a label expansion for its obesity drug Zepbound, adding a new four-dose, single-patient-use KwikPen designed to deliver a full month of treatment in a single device.
The approval marks an expansion of delivery options for Zepbound (tirzepatide), which is already available in single-dose vials. Lilly said the KwikPen is intended to give patients and healthcare providers more flexibility in choosing a format that best fits individual preferences and circumstances.
Zepbound is the No. 1 prescribed injectable obesity-management medication, helping adults achieve meaningful and clinically proven weight loss, on average, up to 50 pounds as seen in SURMOUNT-5, said Ilya Yuffa, executive vice president and president of Lilly USA and Global Customer Capabilities.
As part of our commitment to supporting people living with obesity in their weight management journey, we are introducing a new option with the Zepbound KwikPen, a device trusted by patients globally and in the United States for other Lilly medicines.
Direct-to-consumer platform
The company is also emphasizing affordability through its direct-to-consumer platform, LillyDirect. Patients with a valid prescription who opt to self-pay through LillyDirect can receive Zepbound in either the KwikPen or single-dose vial, with pricing starting at $299 per month for the 2.5 mg starting dose.
Lilly said more than 1 million patients accessed its treatments through LillyDirect in 2025. The company added that one in three new patients beginning a branded weight management medication last year was prescribed Zepbound self-pay vials, underscoring demand for alternative access models amid ongoing pricing scrutiny in the GLP-1 market.
Lilly said Zepbounds growing use is driven in part by clinical data showing substantial weight loss. In the 72-week SURMOUNT-1 trial, adults taking the 15 mg dose lost an average of 20.9% of their body weight, compared with 3.1% for those on placebo. In the open-label SURMOUNT-5 study, patients taking Zepbound lost an average of 50 pounds, or 20.2% of body weight, compared with 33 pounds, or 13.7%, among those taking injectable Wegovy.
Zepbound is approved for adults with obesity, as well as certain adults who are overweight and have at least one weight-related medical condition, to help reduce excess body weight and maintain weight loss. It is also approved for adults with moderate-to-severe obstructive sleep apnea and obesity to improve OSA symptoms.
Lilly cautions that Zepbound is not for cosmetic weight loss and that individual results may vary. The drug carries a boxed warning about the risk of thyroid tumors, including thyroid cancer.
It should not be used by patients with a personal or family history of medullary thyroid carcinoma or by those with Multiple Endocrine Neoplasia syndrome type 2. Zepbound should also not be used with other tirzepatide-containing products or GLP-1 receptor agonists, and its safety and effectiveness in children have not been established.
Posted: 2026-02-24 13:51:59

















