FDA Accepts Galderma’s BLA Resubmission for Liquid Neuromodulator RelabotulinumtoxinA

Galderma has announced that the US Food and Drug Administration (FDA) has accepted the resubmission of a Biologics License Application (BLA) for relabotulinumtoxinA (Relfydess), a next-generation neuromodulator under review for the temporary improvement of moderate-to-severe glabellar lines and lateral canthal lines in adult patients.¹ According to data supporting the application, clinical effects can be observed as early as day 1 following treatment, with improvements maintained for up to 6 months.

Unique Mechanism of Action

RelabotulinumtoxinA has been developed as a ready-to-use liquid neuromodulator, differentiated by its manufacturing approach and formulation. The product is produced using Galderma’s proprietary PEARL Technology (Precipitation, Extraction, and Activity-preserving Refined Liquid), which is designed to preserve molecule integrity. This design objective is linked to 2 performance attributes emphasized in the clinical development program: rapid onset of action and sustained duration of effect. As a ready-to-use liquid neuromodulator, relabotulinumtoxinA does not require reconstitution. It is optimized for volumetric dosing, a feature designed to simplify preparation, enhance ease of use, and support consistent dose and volume delivery. This format may help reduce variability associated with dilution practices and streamline workflow in busy clinical settings.

“There has been a historic lack of innovation in this time, meaning patients and health care professionals have had to settle for traditional manufacturing and reconstitution processes that can limit performance, ease of use, and reliability,” Bill Andriopoulos, PhD, Head of Global Medical Affairs at Galderma, said in a recent interview with Dermatology Times.

Supporting Clinical Data

In particular, the US filing is supported by the READY (REelabotulinumtoxin Aesthetic Development StudY) clinical program, a large-scale, phase 3 development effort comprising four trials and enrolling more than 1,900 participants. Across these studies, relabotulinumtoxinA was evaluated in adult patients with moderate-to-severe dynamic facial lines, including glabellar lines and crow’s feet. Results from the program demonstrated a rapid onset profile, with some patients showing visible improvement from day 1, and sustained efficacy lasting up to 6 months. These attributes align with evolving patient and injector preferences for treatments that combine quick visible results with longer intervals between retreatment.

Furthermore, the outcomes were consistent across patients with moderate and severe baseline wrinkle severity. In addition to aesthetic endpoints, patient-reported outcomes indicated improvements in psychological well-being, reflecting the broader impact of facial aesthetic treatments. Additional data presented at TOXINS 2026 included results from an in vivo head-to-head diffusion study comparing relabotulinumtoxinA with onabotulinumtoxinA in a rat model.² The findings showed similar and limited diffusion profiles between the 2 agents; expected muscle inhibition with similarly limited diffusion to adjacent muscles. These results align with phase 3 data demonstrating a favorable tolerability profile, low eyelid ptosis rates comparable to established neuromodulators, and no evidence of remote toxin spread.

Next Regulatory Steps

RelabotulinumtoxinA has already received marketing authorization in over 20 countries, including in the European Union, the United Kingdom, parts of Asia, and Australia. Ongoing regulatory submissions in additional regions reflect Galderma’s broader strategy to establish a global presence for the product. In the US, however, relabotulinumtoxinA remains an investigational biologic pending FDA review. If approved, it would enter a competitive US neuromodulator market.

“We pioneered the development of RelabotulinumtoxinA to address the growing demand for faster-acting and longer-lasting anti-wrinkle solutions. We’re excited about the potential to bring this innovative neuromodulator to the U.S., offering advanced performance and ease of use and building on our portfolio of neuromodulators that meets the full spectrum of injector and patient needs,” Baldo Scassellati Sforzolini, MD, PhD, Global Head of R&D at Galderma, said in a statement.¹

References

1. Galderma Announces U.S. FDA Acceptance of RelabotulinumtoxinA Biologics License Application Resubmission. News release. Business Wire. Published February 2, 2026. Accessed February 2, 2026. https://www.businesswire.com/news/home/20260201157212/en/Galderma-Announces-U.S.-FDA-Acceptance-of-RelabotulinumtoxinA-Biologics-License-Application-Resubmission

2. Nicodèm E, et al. Similar and Limited In Vivo Diffusion for relaBoNT-A and onaBoNT-A. Abstract #0103 presented at TOXINS; January 14-17, 2026; Madrid, Spain.