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Drug

Tildrakizumab

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Ilumya.

RxNorm2053436UNIIDEW6X41BEK
1
Research papers
3
Active clinical trials
6
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Indication expansion: TILDRAKIZUMAB-ASMN (BLA761067)

Regulatory2026-07-16FDA

Utilization of a Cutaneous Therapy In Situ Microdevice

Clinical trial2026-06-03Results expected Q2 2030 · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis

Clinical trial2026-04-01Results posted · ClinicalTrials.gov

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis

Clinical trial2026-01-21Primary completion · ClinicalTrials.gov

Indication expansion: TILDRAKIZUMAB-ASMN (BLA761067)

Regulatory2025-12-12FDA

Effects of Tildrakizumab on Coronary Microvascular Function in Moderate-Severe Psoriasis

Clinical trial2025-11-25Results posted · ClinicalTrials.gov

A Phase II Trial of Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease

Clinical trial2025-10-21Results posted · ClinicalTrials.gov

A Multicenter, Randomized, Placebo and Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis

Clinical trial2025-04-07Primary completion · ClinicalTrials.gov

Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study

Clinical trial2025-01-31Completed · ClinicalTrials.gov

Indication expansion: TILDRAKIZUMAB-ASMN (BLA761067)

Regulatory2024-04-03FDA

Indication expansion: TILDRAKIZUMAB-ASMN (BLA761067)

Regulatory2022-12-19FDA

Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial.

Research2015-10-15The British journal of dermatology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tildrakizumab
Aliases & brands
Ilumya
RxNorm CUI
2053436
UNII
DEW6X41BEK
Regulatory jurisdictions
emafda

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2018-03-20 → 2018-09-17)
Earliest approval
2018-03-20
Latest approval
2026-07-16
Authorities
FDA · EMA
Total events
6
fdaU.S. Food and Drug Administration· 5 events
2026-07-16Indication expansion
Indication expansion: TILDRAKIZUMAB-ASMN (BLA761067)
Evidence ↗
2025-12-12Indication expansion
Indication expansion: TILDRAKIZUMAB-ASMN (BLA761067)
Evidence ↗
2024-04-03Indication expansion
Indication expansion: TILDRAKIZUMAB-ASMN (BLA761067)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2018-09-17ApprovalMulti-authority
Approval: Ilumetri (EMA)

Indication: Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

17 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
17
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
1
Recruiting
13
Late-stage (III+)
12
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 17
Early Phase 11Phase 1 / 21Phase 22Phase 2 / 31Phase 35Phase 47

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study

CompletedPH IVRadboud University Medical Centern=2442025

Effects of Tildrakizumab on Coronary Microvascular Function in Moderate-Severe Psoriasis

CompletedPH IVMarcelo F. Di Carli, MD, FACCn=362024

Effects of Tildrakizumab (ILUMYA) Use on Epigenetic Age Acceleration and Psoriasis

CompletedPH IVCarlos Wambiern=302024

Predicting Inflammatory Skin Disease Response to IL-23 Blockade

CompletedPH IVUniversity of California, San Franciscon=72023

Recent completions

Trials that read out recently, adding to the completed evidence base.

Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study

CompletedPH IVRadboud University Medical Centern=2442025

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis

CompletedPH IIISun Pharmaceutical Industries Limitedn=992025

Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

CompletedPH IPremier Specialists, Australian=122024

Effects of Tildrakizumab on Coronary Microvascular Function in Moderate-Severe Psoriasis

CompletedPH IVMarcelo F. Di Carli, MD, FACCn=362024

A Phase II Trial of Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease

CompletedPH IIMedical College of Wisconsinn=512024

Effects of Tildrakizumab (ILUMYA) Use on Epigenetic Age Acceleration and Psoriasis

CompletedPH IVCarlos Wambiern=302024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • The British journal of dermatology1
Leading researchers
  • Bowman EP1
  • Gottlieb AB1
  • Krueger JG1
  • Langley RG1
  • Li Q1
  • Mehta A1
  • Nakagawa H1
  • Papp K1
Leading institutions
free-text, unnormalised
  • Comprehensive Center for Inflammation Medicine1
  • Dalhousie University1
  • Laboratory for Investigative Dermatology1
  • Medical University of Vienna1
  • SCIderm Research Institute and Dermatologikum Hamburg1
  • The Jikei University School of Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.