Key Points on Icotrokinra Following FDA Approval for Psoriasis, With Linda Stein Gold, MD

Linda Stein Gold, MD, spoke with the HCPLive editorial team about icotrokinra (Icotyde) and its recent approval by the US Food and Drug Administration (FDA) for moderate to severe plaque psoriasis in adult and adolescent patients aged 12 and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy.1,2

Stein Gold addressed the gap this medication fills. Icotrokinra is the first oral targeted peptide to selectively block the interleukin (IL)-23 receptor, introducing a new mechanistic class to the psoriasis armamentarium. In her responses, Stein Gold framed the approval as addressing a longstanding unmet need in the oral treatment space.

“I think we've had a big unmet need for our moderate to severe plaque psoriasis patients,” Stein Gold explained. “We have great biologic agents, we have good topical agents, but the oral space really needed something that had very good efficacy, very good safety, and very good tolerability. So I think that this drug fills that need.”

While biologics and topical agents have served those living with moderate to severe psoriasis reasonably well, Stein Gold noted the oral category had been missing an option. In her view, the treatment delivers on all efficacy, safety, and tolerability, producing efficacy she described as comparable to a biologic agent while preserving the convenience and tolerability expected of an oral medication. That profile, she said, positions it well for any patient who needs systemic therapy.

She was also asked about the efficacy and safety picture for dermatologists weighing icotrokinra against agents they already know. In her response, Stein Gold pointed to the breadth and design of the ICONIC phase 3 program as the basis for confidence. The drug was studied not only against a placebo but also head-to-head against deucravacitinib, which she identified as having previously demonstrated the best efficacy record among oral medications in this space.

“What we see is the drug starts to kick in fairly rapidly,” Stein Gold said. “We see a nice steep slope, and there's good separation from the placebo, but also from deucravacitinib, as early as week four.”

This separation was described as continuing across the full 16-week primary endpoint period. Approximately 70% of those assessed attained clear or almost clear skin by the 16-week mark, with this level of response holding through long-term follow-up.

Stein Gold also described the adolescent data as good news, noting, for pediatric dermatologists managing patients right at the approved threshold of 12 years and 40 kg, icotrokinra actually performed better in adolescents than it did in adults. This was noted, while the drug maintained the same strong tolerability and safety profile seen across the broader trial population.

The once-daily oral dosing was also highlighted by Stein Gold as a practical advantage for this age cohort. She noted many adolescent patients had been and would be relieved not to require an injection.

Disclosures: Stein Gold has reported serving as an investigator, advisor, or speaker for AbbVie, Amgen, Arctis, Bristol Myers Squibb, Dermavant, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, and UCB. AWA has served as a research investigator, scientific advisor, or speaker to AbbVie, Amgen, Arcutis, BMS, Boehringer Ingelheim, Dermavant Sciences, Eli Lilly, Galderma, Incyte, Johnson & Johnson, Leo Pharma, Novartis, Parexel, Pfizer, Regeneron, Sanofi, Takeda, and UCB. RB is an advisory board member, consultant, speaker, investigator for, or received honoraria or grants from AbbVie, Alumis, Amgen, AnaptysBio, Arcutis, BMS/Celgene, Eli Lilly, Johnson & Johnson, LEO Pharma, Organon, Nimbus, Takeda, UCB, VentyxBio, Vyne, Xencor, and Zurabio, and is also an employee and shareholder of Innovaderm Research.

References

1. Campbell P. Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis. HCPLive. March 18, 2026. Accessed March 20, 2026. https://www.hcplive.com/view/icotrokinra-receives-fda-approval-for-psoriasis.

2. Johnson and Johnson. FDA approves ICOTYDE (icotrokinra), the first and only targeted oral peptide IL-23 receptor antagonist, for the treatment of moderate-to-severe plaque psoriasis. Press release. Published March 18, 2026. Accessed March 20, 2026. https://www.jnj.com/media-center/press-releases.