The injectable treatment showed a 30-percentage-point advantage over placebo in submental fat responder rates after a single treatment cycle, supporting plans for a regulatory filing in China by year-end.
Raziel Therapeutics and Fosun Pharma announced positive topline results from a Phase 3 registration trial in China evaluating RZL-012 for the reduction of submental fat, clearing the way for a New Drug Application (NDA) submission to Chinese regulators by the end of 2026.
The pivotal trial, conducted in partnership with Fosun Pharma through its affiliate JuveStar, evaluated the safety and efficacy of RZL-012 after a single treatment cycle in 480 patients, with 360 receiving the active compound and 120 receiving placebo. Efficacy was assessed 84 days after treatment.
According to the companies, the trial met every primary and secondary endpoint, with the primary responder rate showing a 30-percentage-point advantage over placebo.
Submental fat is the first of several planned aesthetic indications for the compound, which Raziel is developing as a prescription product for the focal fat reduction market.
“We are thrilled with the success of RZL-012 in this Phase 3 trial in China. This data demonstrates the superiority of RZL-012 in the focal fat reduction market. We believe RZL-012 will become the gold standard treatment for fat reduction across aesthetic indications,” says Alon Bloomenfeld, founder and CEO of Raziel Therapeutics, in a release.
Expansion Into Body Contouring
Building on the submental fat results, Fosun is preparing a new trial evaluating RZL-012 in body contouring. The companies described the move as a signal of confidence in the compound’s potential across the broader focal fat reduction market, which they characterized as large, underpenetrated, and complementary to the growing use of systemic weight-loss therapies.
“At Fosun, our values are rooted in care for life, innovation, excellence, and sustained partnership. Raziel shares those values, and these results reinforce our confidence in RZL-012’s potential to address a significant unmet need in medical aesthetics,” says Phillip Cui, co-CEO of Fosun Health Capital, in a release.
ID 354158447 | Aesthetic © Dmytro Dudchenko | Dreamstime.com
