Ilumya

(Tildrakizumab)

ApprovedMonoclonal antibody

Tildrakizumab is used to treat moderate to severe plaque psoriasis, a skin condition that causes thick, red, scaly patches on the skin.[2] Ilumya is currently approved and in use across 6 indications[4].[1]

Ilumya is one of 173 monoclonal antibody programs targeting Psoriasis. It is currently in Approved.

Indications

Total Trials

Active Trials

172

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

PsoriasisTerminated

Psoriasis VulgarisUnknown

Immune System DiseaseUnknown

Genital PsoriasisActive, not recruiting

Atopic DermatitisNot yet recruiting

Skin DiseaseCompleted

PsoriasisApproved

Terminated

Psoriasis VulgarisPreclinical

Unknown

Immune System DiseasePreclinical

Unknown

Genital PsoriasisPhase 3

Active, not recruiting

Atopic DermatitisApproved

Not yet recruiting

Skin DiseaseApproved

Completed

Competition

Competitive Landscape

127 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Ilumya

Sun Pharmaceutical Industries, Inc.

Approved

1 2

Cytosar

Teva

Phase 3

1 3

Fludara

Sanofi

Phase 3

1 4

Adtralza

LEO Pharma

Phase 3

16 5

Amlitelimab

Sanofi

Phase 3

2 6

DUPIXENT

Regeneron

Phase 3

1 7

Certolizumab

Johnson & Johnson

Phase 3

1 8

Jaktinib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase 3

4 9

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

2 10

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Genital Psoriasis

NCT06611163

Q2 2030

Post-ApprovalNot yet recruiting

Atopic Dermatitis

NCT07352566

Q3 2031

Phase 2/3Active, not recruiting

Psoriasis

NCT03997786

Clinical

Trials by Indication[1]

Psoriasis14 trials

Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Completed·AAlmirall, S.A.··NCT04203693·331 enrolled

A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis

Completed·SShenzhen Kangzhe Pharmaceutical Co., Ltd.·Phase 3·NCT05108766·220 enrolled

A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)

Completed· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 3·NCT01722331·772 enrolled

Show 11 more trials

A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)

Completed· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 3·NCT01729754·1,090 enrolled

MIcrovascular dysfuNction In Moderate-severe Psoriasis

Completed·MMarcelo F. Di Carli, MD, FACC·Phase 4·NCT04271540·36 enrolled

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Completed·RRadboud University Medical Center·Phase 4·NCT04340076·244 enrolled

Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy

Completed·AAlmirall, S.A.·Phase 4·NCT04263610·190 enrolled

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Active, not recruiting· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 2/3·NCT03997786·135 enrolled

Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)

Completed·AAlmirall, S.A.·Phase 4·NCT04229836·178 enrolled

A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01225731·355 enrolled

A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis

Recruiting·AAlmirall, S.A.··NCT06030076·50 enrolled

A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO)

Recruiting·AAlmirall, S.A.··NCT06029257·110 enrolled

Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

Completed· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 3·NCT03897075·99 enrolled

Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis

Terminated·AAlmirall, S.A.·Phase 4·NCT04339595·47 enrolled

ESS2 trials

A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting

Active, not recruiting·AAlmirall, S.A.··NCT06488170·42 enrolled

Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study

Completed·AAlmirall, S.A.··NCT04823247·782 enrolled

Vitiligo1 trial

Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Completed·PPremier Specialists, Australia·Phase 1·NCT04971200·12 enrolled

Bullous Pemphigoid1 trial

The Effects of Tildrakizumab in Treatment of Bullous Pemphigoid

Unknown status·—·Phase 1·NCT04465292·16 enrolled

Immune Response1 trial

Psoriatic Immune Response to Tildrakizumab

Unknown status·UUniversity of California, San Francisco·Phase 4·NCT05390515·10 enrolled

7 more indications

Abiraterone Acetate1 trial

Abiraterone Acetate in Combination With Tildrakizumab

Terminated·IInstitute of Cancer Research, United Kingdom·Phase 1/2·NCT04458311·13 enrolled

Acute Graft Versus Host Disease1 trial

Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease

Completed·MMedical College of Wisconsin·Phase 2·NCT04112810·51 enrolled

Skin Disease1 trial

Predicting Inflammatory Skin Disease Response to IL-23 Blockade

Completed·UUniversity of California, San Francisco·Phase 4·NCT04541329·7 enrolled

Acute Lymphoblastic Leukemia1 trial

Tilrdakizumab Almirall

Active, not recruiting·UUniversity Hospital Schleswig-Holstein··NCT07244744·3 enrolled

Age1 trial

Effects of Tildrakizumab on Epigenetic Age

Completed·CCarlos Wambier·Phase 4·NCT05110313·30 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Genital Psoriasis1 trial

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

Active, not recruiting· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 3·NCT06611163·206 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 20, 2018

ILUMYA

BLA BLA761067

Mar 20, 2018

ILUMYA

NDA BLA761067

Dec 19, 2022

ILUMYA

NDA BLA761067

Apr 3, 2024

ILUMYA

NDA BLA761067

Dec 12, 2025

ILUMYA

NDA BLA761067

Jul 16, 2026

ILUMYA

NDA BLA761067

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Tildrakizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ilumya drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tildrakizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tildrakizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761067). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sun Pharmaceutical Industries, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Il-23p19 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Sun Pharmaceutical Industries, Inc.

Ilumya

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2030

Q3 2031

Trials by Indication[1]

Psoriasis14 trials

ESS2 trials

Vitiligo1 trial

Bullous Pemphigoid1 trial

Immune Response1 trial

Abiraterone Acetate1 trial

Acute Graft Versus Host Disease1 trial

Skin Disease1 trial

Acute Lymphoblastic Leukemia1 trial

Age1 trial

Atopic Dermatitis1 trial

Genital Psoriasis1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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