FDA Clears IND for Rubedo’s GPX4 Modulator in Actinic Keratosis

Key Takeaways

• Rubedo’s investigational compound RLS-1496 will enter U.S. trials for actinic keratosis in late 2025, according to a statement from the company.

• The drug targets senescent cells via GPX4 modulation, a novel mechanism.

• Dr. Emma Guttman-Yassky joins Rubedo’s clinical advisory board.

Rubedo Life Sciences has received FDA clearance for a second Investigational New Drug (IND) application for its lead compound RLS-1496, enabling a Phase 1b/2a trial in patients with actinic keratosis to begin in Q4 2025.

According to a press release from the manufacturer, RLS-1496 is a first-in-class selective glutathione peroxidase 4 (GPX4) modulator that targets senescent cells implicated in inflammaging and degenerative skin diseases.The investigational agent is also being evaluated in an ongoing European trial for plaque psoriasis, atopic dermatitis (AD), and photoaged skin. Data from that study are expected in late 2025.

“We are thrilled to reach another important milestone with our lead candidate RLS-1496,” said Frederick Beddingfield, III, MD, PhD, Rubedo CEO, in a press release. “This second IND clearance supports our focus on the potential of RLS-1496 as the first-ever GPX4 modulator to treat an array of age-related diseases and conditions."

New Board Member Announcement

The company also announced the addition of Emma Guttman-Yassky, MD, PhD, to its Clinical Advisory Board. Dr. Guttman-Yassky, a leading dermatologist and immunologist at the Icahn School of Medicine at Mount Sinai, joins four other clinician-researchers advising Rubedo on its strategic direction.

“This IND clearance is an important step forward in making these types of innovations a reality,” Dr. Guttman-Yassky said in the release.

Source: Rubedo Life Sciences press relaese. September 17, 2025.