Interleukin-23 Antagonist
Cross-indication landscape: approved drugs, active Phase 3, sponsors, and upcoming readouts.
About Interleukin-23 Antagonist
Interleukin-23 Antagonist drugs represent a significant advancement in treating inflammatory and autoimmune diseases by targeting a key cytokine in the immune response pathway. Interleukin-23 (IL-23) plays a critical role in the differentiation and survival of T helper 17 (Th17) cells, which are implicated in the pathogenesis of various chronic inflammatory conditions. By blocking the action of IL-23, these therapies effectively dampen the inflammatory cascade, leading to clinical improvement. The first-in-class drug, STELARA (ustekinumab), launched in 2009, paved the way for a new era of targeted biologic therapies. Initially approved for plaque psoriasis and psoriatic arthritis, the therapeutic landscape for IL-23 antagonists has since expanded considerably.
These agents are now approved for a range of conditions characterized by immune dysregulation, including moderate-to-severe plaque psoriasis, active psoriatic arthritis, and inflammatory bowel diseases like ulcerative colitis and Crohn's disease. The development of next-generation IL-23 antagonists has focused on enhancing selectivity and improving patient convenience through different dosing regimens and administration routes. The field is characterized by ongoing innovation, with a robust pipeline and the emergence of biosimilars indicating a maturing market and increasing accessibility.
The success of IL-23 antagonism underscores the power of precisely targeting specific immune pathways to manage complex diseases. As research continues, the understanding of IL-23's role in other inflammatory conditions may lead to further therapeutic applications, solidifying the importance of this drug class in modern medicine. The ongoing clinical trials and the introduction of new agents suggest a dynamic future for Interleukin-23 Antagonist therapies, promising improved outcomes for patients with unmet needs.
11 FDA-approved Interleukin-23 Antagonist drugs, including ILUMYA, with 53 active Phase 3 trials across 8 indications from 8 active sponsors. Explore approved drugs, the cross-indication pipeline, sponsors, and the Phase 3 readout calendar below.
Approved Interleukin-23 Antagonist Drugs
11 totalInterleukin-23 Antagonist therapies have evolved significantly since the introduction of the first-in-class drug, STELARA (ustekinumab), by Johnson & Johnson in 2009 for plaque psoriasis and psoriatic arthritis. This initial success paved the way for subsequent generations of IL-23 inhibitors, with drugs like TREMFYA (guselkumab) and SKYRIZI (risankizumab-rzaa) offering potentially improved efficacy or more convenient dosing schedules. These later entrants often exhibit higher selectivity for the p19 subunit of IL-23, leading to a more targeted blockade of the inflammatory pathway and potentially fewer off-target effects compared to earlier agents that also targeted IL-12. The evolution reflects a drive towards greater precision in immunotherapy. Individual Interleukin-23 Antagonist drugs differentiate themselves through various clinical and pharmacokinetic profiles. For instance, TREMFYA and SKYRIZI are known for their high efficacy in moderate-to-severe plaque psoriasis, with SKYRIZI demonstrating strong results in head-to-head comparisons. Dosing frequency varies, with some agents administered every 8-12 weeks after initial loading doses, enhancing patient adherence. OMVOH (mirikizumab-mrkz) by Eli Lilly marked an expansion into inflammatory bowel disease, specifically ulcerative colitis and Crohn's disease, highlighting the broader applicability of IL-23 blockade. WEZLANA, a biosimilar to STELARA from Amgen, and other recent ustekinumab biosimilars like PYZCHIVA, OTULFI, YESINTEK, and STARJEMZA, are entering the market, increasing therapeutic options and potentially driving down costs. Today, Interleukin-23 Antagonist drugs are well-established treatments, often used as second-line or later therapies for moderate-to-severe plaque psoriasis and psoriatic arthritis, and increasingly as first-line options for inflammatory bowel disease. The influx of ustekinumab biosimilars, with approvals starting in 2023 and continuing into 2024 and 2025, signifies a maturing market where originator biologics face direct competition. This dynamic is reshaping the commercial landscape, making these advanced therapies more accessible. While generally well-tolerated, class-wide considerations around infection risk and monitoring remain important aspects of their clinical positioning.
Interleukin-23 Antagonist Indications in Trials
Active industry trialsThe current pipeline activity for Interleukin-23 Antagonist therapies is heavily concentrated in inflammatory bowel diseases and related arthritic conditions. Crohn's Disease leads with 5 active trials, closely followed by Psoriatic Arthritis with 4 active trials. Ulcerative Colitis also shows significant interest with 3 active trials. The indications of Crohn Disease and Plaque Psoriasis each have 2 active trials, with Psoriasis also featuring 2 trials, underscoring the continued focus on dermatological and gastrointestinal manifestations of IL-23 driven inflammation. This distribution indicates a strong clinical conviction in the efficacy of IL-23 blockade for these specific autoimmune pathologies. The expansion frontier for Interleukin-23 Antagonist drugs extends beyond their established indications, exploring new patient subpopulations and potentially novel therapeutic combinations. While the provided data focuses on specific indications, the underlying research likely investigates earlier lines of therapy, treatment of refractory patient groups, and combinations with other immunomodulators to achieve synergistic effects. The development of OMVOH for Ulcerative Colitis and Crohn's Disease by Eli Lilly exemplifies this expansion into IBD. Future pipeline developments may also explore other IL-23 mediated conditions, although current trial data does not explicitly detail these areas. The dominance of injectable monoclonal antibodies suggests a continued reliance on this modality, though exploration of alternative delivery systems or oral agents remains a long-term possibility. Looking ahead to the next 6-12 months, key clinical trial readouts in Crohn's Disease and Ulcerative Colitis are anticipated, which could further solidify the role of IL-23 antagonists in gastroenterology. The performance of newer agents and biosimilars in these indications will be closely watched. While the pipeline appears robust for inflammatory bowel diseases and psoriatic arthritis, the success in other autoimmune conditions may depend on specific patient stratification and understanding of IL-23's precise role in those pathologies. A thinning pipeline in areas outside of the core indications could signal a saturation of research or a lack of compelling preclinical data, whereas continued expansion would suggest a rich therapeutic vein yet to be fully exploited.
Top Interleukin-23 Antagonist Sponsors
Industry trials, any indicationJanssen Research & Development, LLC, stands as the dominant player in the Interleukin-23 Antagonist space, leading with an impressive 14 active trials. This leadership is largely attributed to their pioneering work with TREMFYA (guselkumab), a highly selective IL-23p19 inhibitor approved for plaque psoriasis and psoriatic arthritis. Janssen's deep franchise in immunology, coupled with ongoing investment in TREMFYA's clinical development across various indications and patient populations, fuels their extensive trial activity. Their commitment reflects a strategic focus on maintaining a leading position in the IL-23 targeted therapy market. Key challengers actively competing in the Interleukin-23 Antagonist arena include AbbVie, with 1 active trial, likely related to their IL-23 inhibitor SKYRIZI (risankizumab-rzaa), which has shown significant efficacy in psoriasis and psoriatic arthritis. UCB Biopharma SRL and Johnson & Johnson Private Limited also show activity with 1 active trial each, suggesting focused development programs. These sponsors are likely exploring label expansions, head-to-head comparisons, or new patient subgroups for their respective IL-23 targeted assets, aiming to capture market share from established players or address unmet needs within the current therapeutic framework. The strategic landscape for Interleukin-23 Antagonist sponsors is increasingly influenced by the global market and the rise of biosimilars. While Janssen maintains a strong presence, the recent emergence of ustekinumab biosimilars from companies like SAMSUNG BIOEPIS CO LTD and Fresenius Kabi, with approvals in 2024, indicates a shift towards broader accessibility and cost competition, particularly in plaque psoriasis and psoriatic arthritis. Sponsors like Amgen and BIOCON BIOLOGICS INC are also entering with biosimilars. Investors and business development scouts should monitor upcoming Phase 3 readouts and regulatory decisions, as these will be critical catalysts for shifting competitive dynamics and identifying new partnership or acquisition opportunities in this evolving therapeutic class.
Interleukin-23 Antagonist Phase 3 Readout Calendar Pro
12 Phase 3 trials testing approved Interleukin-23 Antagonist drugs across 8 indications from 4 sponsors. Earliest readout: Q4 2024.
Coverage: trials whose intervention is an approved Interleukin-23 Antagonist drug. Pre-approval candidates with development codes are not yet linked.
Methodology
Approved drugs sourced from FDA `pharmClassEpc` (Established Pharmacologic Class) labeling. Active industry trials matched by intervention name (brand or generic) — same coverage approach as our target pages, with the same limitation: pre-approval candidates using development codes won't match until they're approved.
"Active" = RECRUITING / ACTIVE_NOT_RECRUITING / NOT_YET_RECRUITING. Sponsor counts include any company running at least one active industry trial.