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Icotyde (oral IL-23) FDA approval — competitive threat to Skyrizi

Icotyde (oral IL-23) FDA approval — competitive threat to Skyrizi

Key Questions

What is Icotyde and when was it FDA approved?

Icotyde is an oral IL-23 inhibitor developed by Protagonist Therapeutics and J&J. It received FDA approval on March 18 based on Ph3 ICONIC trial data. A Q2 launch is planned with an adherence advantage over injectables.

How does Icotyde pose a competitive threat to Skyrizi?

Icotyde targets the same IL-23 pathway as AbbVie's Skyrizi for psoriasis but offers oral administration for better adherence. BMO projects peak sales of $3.2B. This could erode Skyrizi's market share in the IL-23 class.

How is AbbVie responding to the Icotyde approval?

AbbVie is countering with the acquisition of Nimble Therapeutics, gaining a preclinical oral peptide IL-23R inhibitor for psoriasis. This positions AbbVie to compete in the oral IL-23 space long-term. Nimble's asset is investigational and in preclinical development.

FDA approved Mar18 Ph3 ICONIC (Prot/J&J); adherence edge; BMO $3.2B peak; Q2 launch. ABBV Nimble preclinical oral peptide IL-23R acq counter.

Sources (1)
Updated Apr 23, 2026