A Faster, Longer-Lasting Wrinkle Relaxer Moves Closer to FDA Approval

UPDATE (February 2026): Galderma announced that the U.S. Food and Drug Administration has accepted the Biologics License Application resubmission for RelabotulinumtoxinA, a key regulatory step toward potential U.S. approval.

“We pioneered the development of RelabotulinumtoxinA to address the growing demand for faster-acting and longer-lasting anti-wrinkle solutions,” said Dr. Baldo Scassellati Sforzolini, Galderma’s Global Head of R&D, in a press release. “We’re excited about the potential to bring this innovative neuromodulator to the U.S.”

At the IMCAS 2025 conference in Paris, Galderma presented new data on its yet-to-be-released injectable, RelabotulinumtoxinA, or Relfydess, which is generating buzz for its potential to work faster and last longer than existing wrinkle relaxers. According to the company, some patients in a phase IIIb trial—an advanced study conducted before regulatory approval—saw visible results as early as Day 1 after treatment. That could set it apart from current neurotoxin treatments, which typically take three to seven days to show effects, depending on the product.

How long does Relfydess last?

Beyond its rapid onset, the study also found that Relfydess maintained results for up to six months, with the median time to return to baseline severity for frown lines and crow’s-feet reported between 24 and 27 weeks. In comparison, most currently available neurotoxins last around three to four months before a touch-up is needed.

How It’s Different

What sets it apart, according to Galderma, is its formulation. Unlike traditional botulinum toxin treatments, which come in a powder form that must be mixed with saline before injection, Relfydess is a ready-to-use liquid. This innovation, developed with Galderma’s PEARL Technology, is designed to preserve the integrity of the active ingredient, minimize inconsistencies in dosing and streamline the injection process for practitioners.

What Galderma Says

“We are proud to share our latest RelabotulinumtoxinA data, which reaffirms the sustained clinical effect and patient satisfaction observed in our READY clinical trial program,” said Dr. Baldo Scassellati Sforzolini in a previous press release. “These findings, together with our proprietary PEARL Technology, reinforce RelabotulinumtoxinA as a safe, effective and innovative treatment option and uphold Galderma’s position at the forefront of aesthetic advancements.”

When will Relfydess be available?

Relfydess is not yet FDA-approved, but Galderma confirmed that the FDA has accepted its Biologics License Application resubmission for the treatment of moderate-to-severe glabellar lines and lateral canthal lines in adults. The company has not announced a U.S. launch timeline.

The neurotoxin has already been approved in more than 20 markets globally, including the European Union and the United Kingdom, and continues to be reviewed by regulatory authorities worldwide. With increasing demand for faster, longer-lasting wrinkle relaxers, it remains one to watch.