In short
JNJ-77242113-AAC, also known as icotrokinra, is an investigational oral tablet being studied for inflammatory conditions. It is a protein-based substance classified as an interleukin-23 (IL-23) receptor antagonist, developed by Janssen. One completed Phase 1 trial with 24 healthy participants investigated how different tablet formulations are absorbed by the body.
JNJ-77242113-AAC, also known as icotrokinra and proposed under the trade name ICOTYDE, is an investigational oral tablet being studied for inflammatory conditions. It is a protein-based substance classified as an interleukin-23 (IL-23) receptor antagonist. The substance has no marketing authorisation in the product records — it is an investigational substance. It is supplied by Janssen-Cilag International N.V.
Key points
- JNJ-77242113-AAC (icotrokinra) is an investigational oral tablet for inflammatory conditions.
- It works as an interleukin-23 (IL-23) receptor antagonist, blocking a key inflammatory pathway.
- The completed Phase 1 trial enrolled 24 healthy participants to compare two tablet formulations.
- The trial measured absorption and bioavailability (AUC and Cmax) after a single 200 mg oral dose.
- A US regulatory review recommended approval for moderate-to-severe plaque psoriasis in adults and adolescents 12 years and older.
- The proposed dosing regimen is 200 mg orally once daily.
What is JNJ-77242113-AAC?
JNJ-77242113-AAC is an investigational oral tablet being developed for the treatment of inflammatory diseases. It is a protein-based substance, meaning it is not a small chemical molecule but a larger biological molecule. The substance is also known by its proposed international nonproprietary name icotrokinra and by its proposed trade name ICOTYDE. It is classified pharmacologically as an interleukin-23 (IL-23) receptor antagonist. The substance has no marketing authorisation in the product records, meaning it is still an investigational substance. The authorisation holder is Janssen-Cilag International N.V.
How does JNJ-77242113-AAC work?
JNJ-77242113-AAC works by blocking the interleukin-23 (IL-23) receptor. Interleukin-23 is a protein in the body that plays a central role in inflammation and is involved in several immune-mediated diseases. By blocking the IL-23 receptor, the substance prevents IL-23 from activating immune cells that drive inflammation. This mechanism is used in the treatment of inflammatory conditions such as plaque psoriasis, where overactive immune responses cause skin inflammation and scaling.
Which conditions is it studied for?
- Inflammatory conditions — the clinical trial listed the condition as inflammatory conditions, reflecting the broad area of immune-mediated diseases the substance targets.
- Moderate-to-severe plaque psoriasis — a US regulatory review recommended approval for treating adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
How is JNJ-77242113-AAC given?
JNJ-77242113-AAC is given as a film-coated tablet for oral use, meaning it is taken by mouth. The clinical trial used a 200 mg dose. The proposed dosing regimen in the regulatory review is 200 mg orally once daily.
What do the clinical trials show?
One completed Phase 1 trial (EU CT number 2023-504720-26-00) investigated the absorption and food effect of different tablet formulations of JNJ-77242113. The trial enrolled 24 healthy participants. The study compared a Phase 3 immediate-release (IR) tablet formulation with a Phase 2 IR tablet formulation under fasted conditions.
The primary outcome measured how much of the drug reaches the bloodstream after a single oral dose. Specifically, it measured the area under the plasma concentration-time curve (AUC) from time 0 to the last measurable concentration (AUClast), AUC from time 0 to infinite time (AUC∞), and the maximum observed plasma concentration (Cmax). These measures describe the rate and extent of absorption and the bioavailability of the substance.
The trial status is completed, meaning the study has finished and results may be available in the registry.
What side effects are known?
The supplementary sources provided do not contain specific information on side effects for JNJ-77242113-AAC. The trial registry record does not report side effect data. Therefore, no side effect information can be presented on this page.