Regulation

Zepbound KwikPen is authorized and available in Canada, Eli Lilly says

Canada now has a new pen format of tirzepatide, the drug sold as Mounjaro and Zepbound in the US, but the announcement disclosed nothing about US availability or timing.

By the Semaglutides news desk··Zepbound

Health Canada authorized Zepbound KwikPen, a tirzepatide injection, on May 13, 2025, and Eli Lilly Canada said on July 9, 2025 that the product is now available in the country [1]. Zepbound KwikPen is tirzepatide, the same active ingredient sold as Mounjaro and Zepbound in the United States.

The company described it as the first and only Health Canada-approved treatment for chronic weight management that activates both the GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors [1]. It is a once-weekly injection, used alongside a reduced-calorie diet and increased physical activity, for adults with a BMI of 30 kg/m2 or higher, or a BMI of 27 kg/m2 to under 30 kg/m2 with at least one weight-related condition such as hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea or cardiovascular disease [1].

What the trial data showed

Health Canada's authorization was based on results from four phase 3 trials: SURMOUNT-1, SURMOUNT-2, SURMOUNT-3 and SURMOUNT-4 [1]. In SURMOUNT-1, a study of 2,539 adults with obesity, or excess weight plus weight-related conditions, but not diabetes, people treated with tirzepatide lost significantly more weight than those on placebo at 72 weeks [1]. At the highest dose of 15 mg, people lost an average of 21.8 kg (48 lbs); at the lowest dose of 5 mg, they lost an average of 15.4 kg (34 lbs); people on placebo lost an average of 3.2 kg (7 lbs) [1].

The SURMOUNT program began in late 2019 and has enrolled more than 5,000 people with obesity or overweight across six registration studies, four of which are global [1].

The company also cited Canadian figures on obesity: one in three Canadians live with obesity, a condition the release says is linked to more than 200 weight-related health conditions [1]. The release put the economic cost of failing to treat obesity as a chronic disease in Canada at $27.6 billion, 20 percent higher than previously estimated [1]. It also cited survey figures that 54 percent of adults with obesity report being stigmatized by coworkers and 64 percent report experiencing weight bias from a health care professional [1].

"This will increase the options for weight management," said Dr. Sean Wharton, an internal medicine physician and weight management specialist, in the release [1]. Mathilde Merlet, general manager and president of Lilly Canada, said the evidence shows obesity is "a chronic disease with severe health implications" [1]. Lisa Schaffer, executive director of Obesity Canada, said new treatments need to be "truly accessible" [1].

Why it matters for patients

Tirzepatide is already sold in the United States under the brand names Mounjaro and Zepbound, but the Canadian announcement did not address whether the KwikPen format is under review, approved or planned for the US market. No US filing date, decision date or launch date was disclosed [1]. Whether a similar penshape reaches US patients has not been reported.

Even when the same molecule is sold in both countries, the two markets have separate regulators, pricing and insurance systems. The release did not state what Zepbound KwikPen costs in Canada, how many doses each pen contains, or whether public or private insurers there will cover it, so those details are not yet known [1].

The clinical data cited in the release describe average results from a trial population; individual results vary, and the release does not compare the KwikPen with other delivery formats of the same drug [1].

What happens next

The July 9, 2025 announcement marks the Canadian launch of the product [1]. No timeline for other countries was included, and no future US milestones were given [1]. The full Zepbound KwikPen product monograph is published by the manufacturer [1].

Sources

  1. https://www.biospace.com/press-releases/zepbound-kwikpen-tirzepatide-injection-the-first-and-only-dual-receptor-agonist-for-the-treatment-of-obesity-now-approved-and-available-in-canada

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