Last Updated: May 11, 2026

CLINICAL TRIALS PROFILE FOR ILUMYA


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All Clinical Trials for ILUMYA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04271540 ↗ MIcrovascular dysfuNction In Moderate-severe Psoriasis Recruiting Marcelo F. Di Carli, MD, FACC Phase 4 2020-08-04 Psoriasis, a common chronic inflammatory skin disease affecting approximately 2% of the population, is associated with increased cardiovascular (CV) risk. Despite the implication of inflammation in this excess risk, it remains unclear whether reducing inflammation reduces the risk of cardiac events. This study proposes to test whether Tildrakizumab, an FDA approved therapy for psoriasis that blocks IL-23 and the Th17 pathway of inflammation, improves coronary vascular function and coronary flow reserve, as measured by noninvasive imaging with cardiac positron emission tomography. In so doing, improvement in coronary vasoreactivity, endothelial function, and tissue perfusion may have beneficial effects on myocardial mechanics, left ventricular deformation and function and, ultimately, symptoms and prognosis. This research may offer novel insights into the contributors of CV risk in psoriasis and provide data to support the development of strategies to prevent cardiovascular events in psoriatic disease.
NCT04347473 ↗ ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis. Recruiting Sun Pharmaceutical Industries Limited Phase 4 2020-04-06 Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
NCT04347473 ↗ ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis. Recruiting Psoriasis Treatment Center of Central New Jersey Phase 4 2020-04-06 Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ILUMYA

Condition Name

Condition Name for ILUMYA
Intervention Trials
Psoriasis 2
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Condition MeSH

Condition MeSH for ILUMYA
Intervention Trials
Psoriasis 2
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Clinical Trial Locations for ILUMYA

Trials by Country

Trials by Country for ILUMYA
Location Trials
United States 2
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Trials by US State

Trials by US State for ILUMYA
Location Trials
New Jersey 1
Massachusetts 1
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Clinical Trial Progress for ILUMYA

Clinical Trial Phase

Clinical Trial Phase for ILUMYA
Clinical Trial Phase Trials
Phase 4 2
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Clinical Trial Status

Clinical Trial Status for ILUMYA
Clinical Trial Phase Trials
Recruiting 2
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Clinical Trial Sponsors for ILUMYA

Sponsor Name

Sponsor Name for ILUMYA
Sponsor Trials
Sun Pharmaceutical Industries Limited 1
Psoriasis Treatment Center of Central New Jersey 1
Marcelo F. Di Carli, MD, FACC 1
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Sponsor Type

Sponsor Type for ILUMYA
Sponsor Trials
Other 2
Industry 1
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ILUMYA (tildrakizumab): Clinical Trials Update, Market Analysis, and 5-Year Projection

Last updated: May 1, 2026

What is ILUMYA and where is it used clinically?

ILUMYA (tildrakizumab) is a monoclonal antibody targeting IL-23p19. It is approved for moderate-to-severe plaque psoriasis in adults, typically after inadequate response to, or intolerance of, other systemic therapies (US label). Its clinical development and launch expanded to specific use niches including biologic-experienced populations and comorbidity-facing registries.

Mechanism and label positioning

  • Target: IL-23p19
  • Drug type: Monoclonal antibody
  • Approved indication (US): Plaque psoriasis (adults with moderate-to-severe disease) (US Prescribing Information).

What do recent clinical-trials signals show for ILUMYA?

The most decision-relevant view of ILUMYA’s pipeline is whether new programs expand label scope (new populations, earlier lines, additional disease entities) or deepen competitive differentiation versus IL-17 and IL-23 peers.

Core evidence base driving current use

ILUMYA’s clinical position is supported by:

  • Phase 3 randomized evidence versus placebo and active comparators in plaque psoriasis populations, including biologic-experienced subgroups (multiple registrational trials).
  • Long-term follow-up demonstrating durability of skin-response endpoints across multi-year follow-up windows (extension studies and long-term safety follow-up reported in publications and trial registries).

Where ILUMYA’s ongoing clinical activity has mattered most

Across the IL-23 class, the main commercial battleground is:

  • Earlier treatment lines (before biologic-experienced status)
  • Broader patient characterization (comorbidities, weight strata)
  • Switching dynamics (patients moving from IL-17 or other biologics)

For ILUMYA specifically, the practical clinical-trials takeaway is that its evidence base continues to be used to maintain payer and prescriber confidence for moderate-to-severe plaque psoriasis and for continued dosing in chronic management settings (US PI; major efficacy/safety publications).

Note: A full “trial-by-trial” update requires a current snapshot of trial registry activity (ClinicalTrials.gov identifiers, latest posted results, and recruitment status). That snapshot is not provided in the source set available in this response.

How big is the plaque psoriasis market and what does that imply for ILUMYA?

Plaque psoriasis is a mature, high-spend specialty biologics market. Demand is driven by:

  • High prevalence of moderate-to-severe disease
  • Chronic dosing schedules
  • Strong prescriber adoption of biologics over time

Market structure and competitive set

IL-23 inhibitors compete mainly with:

  • IL-17 inhibitors (fast onset skin clearance, strong adverse event and dosing narratives)
  • TNF inhibitors (older biologics, discounted, and used for price-sensitive lines)
  • Other IL-23 inhibitors (same pathway class competition)

Competitive dynamics that matter for ILUMYA economics

For an IL-23 agent, pricing and access depend on:

  • Net price and formulary placement vs other IL-23 competitors
  • Switching rates from IL-17 and between IL-23 agents
  • Real-world persistence and injection schedule adherence (dosing cadence)

ILUMYA’s dosing schedule is an important commercial attribute in payer discussions (US PI).

What share and revenue trajectory can be projected from category behavior?

Because ILUMYA’s growth depends on both share and persistence inside a competitive biologics market, projections should be anchored to:

  • Mature class adoption trends for IL-23
  • Competitive share shifts among IL-23 agents
  • Ongoing erosion from IL-17 preference in specific subgroups and from biosimilar TNF in price-driven segments

Projection framework (5-year)

A practical projection uses three layers:

  1. Market growth: modest overall growth after maturity, with IL-23 mix shift supporting category-level gains.
  2. Share dynamics: IL-23-to-IL-23 switching and IL-17 displacement influence share.
  3. Persistence and discontinuation: drug-level survival curves (real-world and trial-informed) influence revenue durability.

This response does not include ILUMYA’s latest sales figures, net price, payer penetration, or an audited share estimate. Without those anchors, a numerically specific revenue forecast cannot be produced from the provided sources.

What business decisions should investors and R&D leaders draw from ILUMYA’s position?

Commercial defensibility drivers

  • IL-23 class tailwinds as prescribers keep adding IL-23 options for chronic plaque psoriasis management (US PI).
  • Consistent clinical evidence base for skin response and long-term safety narrative supports formulary continuation.

Key execution risks

  • IL-17 and IL-23 peers compete on speed of skin clearing, patient-reported outcomes, and dosing convenience.
  • Biosimilar-driven pricing pressure can reduce absolute biologics unit revenue growth even as volumes rise.

What is the practical roadmap for ILUMYA’s next commercial phase?

For ILUMYA, the next-phase roadmap is less about “whether it works” and more about:

  • Formulary retention in large accounts
  • Switch capture from IL-17 and other biologics
  • Rapid conversion of biologic-naïve and biologic-experienced patients who need IL-23 option differentiation

Key Takeaways

  • ILUMYA (tildrakizumab) is an IL-23p19 monoclonal antibody positioned for moderate-to-severe plaque psoriasis in adults (US Prescribing Information).
  • The clinical record that matters commercially is durable efficacy and long-term safety used to support continued chronic dosing and formulary access (US PI; registrational and extension evidence).
  • A precise 5-year revenue forecast cannot be numerically stated here because the necessary latest ILUMYA sales, net price, formulary share, and trial registry update set are not included in the provided sources.
  • Investor focus should center on IL-23 competitive share shifts, payer retention, and persistence against IL-17 and other IL-23 peers (US PI; class competitive context).

FAQs

  1. What is ILUMYA’s mechanism of action?
    It targets IL-23p19 (US Prescribing Information).

  2. What indication does ILUMYA have in adults?
    Moderate-to-severe plaque psoriasis in adults (US Prescribing Information).

  3. How does ILUMYA fit against IL-17 inhibitors?
    IL-17 agents often compete on speed of skin clearance, while IL-23 agents compete on durability, safety messaging, and overall treatment strategy in chronic management (US PI; class context).

  4. What determines ILUMYA’s commercial growth in mature plaque psoriasis?
    Formulary placement, switch dynamics (IL-17 to IL-23 and IL-23 to IL-23), and treatment persistence.

  5. Can a numeric 5-year ILUMYA revenue projection be provided from the available evidence here?
    Not with a complete, auditable basis because the latest sales, net pricing, and share inputs are not included in the cited source set.


References (APA)

  1. U.S. Food and Drug Administration. (n.d.). ILUMYA (tildrakizumab-asmn) Prescribing Information. FDA. https://www.accessdata.fda.gov/

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