Drugs / Tildrakizumab
Tildrakizumab
also known as
Ilumetri · Ilumya · MK-3222 · SCH 900222 · SUNPG18_07 I · SUNPG18_07 II · TIL · Tildrakizumab asmn
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed psoriasis 1 milestone | |||||
| Filed | EU (EMA) | — | psoriasis | 2017-03-24 | “At the beginning of 2017, we submitted the regulatory filing in Europe of our first biologic, tildrakizumab” almirall.com ↗ “March, 24 th . Regulatory filing of tildrakizumab in EU.” almirall.com ↗ |
| Filed psoriatic arthritis 1 milestone | |||||
| Filed | US (FDA) | ILUMYA | psoriatic arthritis | 2026-03-16 | “Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for ILUMYA for the treatment of adults with active psoriatic arthritis.” sunpharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | ILUMYA | — | 2022-12-19 – 2026-07-16 | fda.gov ↗ |
| Approved | EU (EMA) | Ilumetri | — | 2018-09-17 | europa.eu ↗ |
| Approved | US (FDA) | ILUMYA | — | 2018-03-20 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04971200 | Sep 2021 → Nov 2024 | connective tissue disorder, hypopigmentation of the skin, vitiligo | Premier Specialists, Australia | Completed | No outcome recorded |
| Phase 0 | NCT04465292 | Sep 2020 → Dec 2022 | bullous pemphigoid | Brigham and Women's Hospital | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04458311 | Dec 2020 → Apr 2023 | castration-resistant prostate carcinoma | Institute of Cancer Research, United Kingdom | Terminated | No outcome recorded Stop: Business |
| Phase 24 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT04112810 | Mar 2020 → Jun 2024 | hematopoietic and lymphoid cell neoplasm | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 2 | NCT02980705 | Nov 2017 → Feb 2019 | ankylosing spondylitis | Sun Pharmaceutical Industries, Inc. | Terminated | Missed primary |
| Phase 2 | NCT02980692 | Apr 2017 → Mar 2019 | psoriatic arthritis | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 2 | NCT01225731 | Oct 2010 → Nov 2011 | psoriasis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03997786 | Jan 2020 → Apr 2025 overdue | psoriasis | Sun Pharmaceutical Industries, Inc. | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03552276 | Jul 2018 → Sep 2023 | psoriatic arthritis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 39 trials · 6 met primary | ||||||
| Phase 3 | NCT06611163 | Mar 2025 → Jan 2026 overdue | psoriasis | Sun Pharmaceutical Industries, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04991116 | Jun 2022 → Dec 2028 expected | psoriatic arthritis | Sun Pharmaceutical Industries, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03897075 | May 2021 → Apr 2024 | pustular psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 3 | NCT05108766 | Dec 2020 → Jun 2021 | psoriasis | Shenzhen Kangzhe Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04314531 | Jul 2020 → Jun 2025 overdue | psoriatic arthritis | Sun Pharmaceutical Industries, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT03897088 | Mar 2019 → Feb 2022 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 3 | NCT01936688 | Sep 2013 → Aug 2018 | psoriasis | Sun Pharmaceutical Industries, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01729754 | Feb 2013 → Sep 2015 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 3 | NCT01722331 | Dec 2012 → Oct 2015 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 410 trials | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05390515 | Sep 2022 → Sep 2028 expected | psoriasis | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05110313 | Apr 2022 → May 2024 | psoriasis | Carlos Wambier | Completed | No outcome recorded |
| Phase 4 | NCT04541329 | Sep 2020 → Jan 2023 | psoriasis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT04340076 | Aug 2020 → Jan 2025 | psoriasis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT04347473 | Apr → Dec 2020 overdue | psoriasis | Psoriasis Treatment Center of Central New Jersey | Recruiting | No outcome recorded |
| Phase 4 | NCT04271540 | Apr 2020 → Jul 2024 | cardiovascular disorder, psoriasis | Marcelo F. Di Carli, MD, FACC | Completed | No outcome recorded |
| Phase 4 | NCT04229836 | Dec 2019 → Nov 2021 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 4 | NCT04263610 | Sep 2019 → Feb 2022 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 4 | NCT03718299 | Jul 2019 → Nov 2021 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT04339595 Background | Jan → Jul 2020 | psoriasis | Almirall, S.A. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Almirall, S.A. | Results Almirall advances skin science and shares new evidence across its dermatology portfolio at EADV 2026 almirall.com ↗ |
| 2026-03-27 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Highlights Advances in Alopecia Areata, Psoriasis, and Acne Research at 2026 AAD Annual Meeting sunpharma.com ↗ |
| 2026-03-16 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces US FDA Acceptance of Supplemental Biologics License (sBLA) Application for ILUMYA® (tildrakizumab-asmn) for the Treatment of Adults with Active Psoriatic Arthritis sunpharma.com ↗
the US Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for ILUMYA for the treatment of adults with active psoriatic arthritis |
| 2025-09-18 | Almirall, S.A. | Results Almirall Presents Long‑Term Results from First Real‑World Dermatology Study Using WHO‑5 Well‑Being Index as Primary Endpoint in the treatment of Psoriasis at EADV 2025 almirall.com ↗
The results of the POSITIVE study show tildrakizumab's long-term effectiveness on both skin outcomes and patient-reported outcomes and demonstrates tildrakizumab's significant value in the long-term holistic management of psoriasis. |
| 2025-07-21 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma’s Phase 3 Clinical Studies Evaluating Tildrakizumab 100 mg (ILUMYA) in Active Psoriatic Arthritis Meet their Primary Endpoint sunpharma.com ↗
Both pivotal studies met their primary endpoint with statistically significant improvements based on ACR20 response rates at Week 24 with tildrakizumab 100 mg (ILUMYA) compared to placebo |
| 2025-06-19 | Almirall, S.A. | Results Almirall shows efficacy of biologics with real-world evidence and new patient-centric research on psychological wellbeing at the 2025 International Congress of Dermatology almirall.com ↗ |
| 2025-03-07 | Sun Pharmaceutical Industries, Inc. | Results ILUMYA® Found Effective for Treatment of Plaque Psoriasis Affecting Nails in Study Presented at 2025 AAD Conference sunpharma.com ↗
Patients treated with ILUMYA demonstrated a significantly higher rate of 75% improvement from baseline in the Nail Psoriasis Severity Index (mNAPSI 75) at Week 28 (25.5% mNAPSI 75 response rate vs. 4.5% in the placebo group; P=0.003). |
| 2024-07-01 | Almirall, S.A. | Results Almirall’s Ilumetri® (tildrakizumab) demonstrates high rates of skin clearance and sustained wellbeing restoration in Adults with Moderate-to-Severe Plaque Psoriasis to general population levels for up to one year almirall.com ↗ |
| 2023-10-11 | Almirall, S.A. | Results Almirall's Ilumetri® (tildrakizumab) significantly improves wellbeing for patients and their relatives in moderate-to-severe plaque psoriasis almirall.com ↗
The data presented in posters showed that Ilumetri ® (tildrakizumab) significantly improved the wellbeing of psoriasis patients, i as well as the wellbeing of their relatives. ii |
| 2023-07-07 | Almirall, S.A. | Results Almirall: Ilumetri® (tildrakizumab) significantly improved the wellbeing of patients with moderate-to-severe plaque psoriasis almirall.com ↗
These first results of the POSITIVE study were presented in a poster at the 25 th World Congress of Dermatology, held in Singapore from 3-7 July. |
| 2023-05-30 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces China NMPA Approval For ILUMETRI (Tildrakizumab Injection) For Treatment Of Adults with Moderate-To-Severe Plaque Psoriasis sunpharma.com ↗
Sun Pharma Announces China NMPA Approval for ILUMETRI (Tildrakizumab Injection) For Treatment of Adults with Moderate-To-Severe Plaque Psoriasis |
| 2021-02-09 | Almirall, S.A. | Results Almirall announces a new publication in the British Journal of Dermatology of ILUMETRI®▼ (tildrakizumab) as the first anti-IL23p19 treatment for which 5-year efficacy and safety data are reported from two phase 3 studies almirall.com ↗
Results of the 5-year pooled data from reSURFACE 1 and reSURFACE 2 demonstrated long-term control of psoriasis, with a large proportion of patients who responded at week 28 maintaining efficacy by both relative and absolute PASI. |
| 2020-10-31 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Announces 5-Year Sustained Efficacy and Safety Results for ILUMYA® in Patients with Moderate-to-Severe Plaque Psoriasis sunpharma.com ↗
Patients with moderate -to-severe plaque psoriasis who continued to receive ILUMYA through five years of continuous treatment maintained consistent and extensive skin clearance with no new safety issues reported.1 |
| 2020-10-30 | Almirall, S.A. | Results First complete dataset in the IL-23p19 class demonstrates ILUMETRI®▼ (tildrakizumab) long term efficacy and safety through 5 years in Patients with Moderate to Severe Psoriasis almirall.com ↗
This new data demonstrate maintained response rates with a consistent safety profile. |
| 2020-10-12 | Almirall, S.A. | Regulatory Almirall announces approval of the reimbursed price for Ilumetri®(tildrakizumab) in France for the treatment of adult patients with severe chronic plaque psoriasis almirall.com ↗
Following the publication of the agreement in the French Official Journal, Ilumetri® (tildrakizumab) will be included in the list of reimbursable medicines by the social insurance for the treatment of adults with severe chronic plaque psoriasis. |
| 2020-06-29 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces Japan MHLW approval of ILUMYA for the treatment of Plaque Psoriasis sunpharma.com ↗ |
| 2020-06-13 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Announces Long-term Insights into the Clinical Use of ILUMYA TM sunpharma.com ↗
Long-term ILUMYA data analysis demonstrated continued improvement and sustained response rates in moderate-to-severe plaque psoriasis and offers clinical insights into bio naïve patient population subset |
| 2019-10-11 | Almirall, S.A. | Results Tildrakizumab confirms its long-term efficacy and safety with the longest IL23p19 data available almirall.com ↗
According to the results of the open-label extension from reSURFACE 1, at week 64, 87% of patients achieved PASI 75, 54% PASI 90 and 31% PASI 100, respectively. |
| 2019-10-09 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Presents Long-term Study Results that Show Significant Skin Clearance with ILUMYA sunpharma.com ↗
Additional data show people with and without metabolic syndrome respond similarly to ILUMYA treatment with comparable, positive results |
| 2019-08-12 | Almirall, S.A. | Regulatory Scottish Medicines Consortium (SMC) provisionally approves Almirall’s Ilumetri®▼ (tildrakizumab), as a cost effective option for adults with moderate-to-severe plaque psoriasis almirall.com ↗ |
| 2019-08-01 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces Regulatory Filing of Tildrakizumab in Japan sunpharma.com ↗
today announced that one of its wholly owned subsidiaries has filed an application for Manufacturing and Marketing Authorization of Tildrakizumab for moderate-to-severe psoriasis and psoriatic arthritis with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. |
| 2019-06-14 | Sun Pharmaceutical Industries, Inc. | Results Late Breaking Phase 2 Data Showing Potential of ILUMYA for Psoriatic Arthritis sunpharma.com ↗
The interim analysis revealed that over 71 percent of patients treated with ILUMYA™ experienced a 20 percent improvement in joint and skin symptoms (ACR20), meeting the primary endpoint of the study. |
| 2019-04-17 | Almirall, S.A. | Regulatory NICE publishes final recommendation for Almirall's ILUMETRI®▼ (Tildrakizumab), as a cost-effective option for adults with moderate-to-severe plaque psoriasis almirall.com ↗ |
| 2019-03-08 | Almirall, S.A. | Regulatory NICE provisionally approves Almirall's ILUMETRI®▼ (tildrakizumab), as a cost effective option for adults with moderate-to-severe plaque psoriasis almirall.com ↗ |
| 2019-03-01 | Sun Pharmaceutical Industries, Inc. | Results ILUMYA 3 Year Data Demonstrates Sustained Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis sunpharma.com ↗ |
| 2018-09-21 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces Australian TGA approval of ILUMYA sunpharma.com ↗
today announced that Sun Pharma has received the Australian Therapeutic Goods Administration (TGA) approval for its speciality product, ILUMYA™ (tildrakizumab) for the treatment of adults with moderate -to-severe plaque psoriasis who are candidates for systemic therapy. |
| 2018-09-18 | Almirall, S.A. | Regulatory The European Commission approves Almirall's ILUMETRI® (tildrakizumab) for moderate-to-severe chronic plaque psoriasis almirall.com ↗
Almirall, S.A. announced today that the European Commission (EC) has approved ILUMETRI ® (tildrakizumab), a humanized, high-affinity IL-23p19 monoclonal antibody, for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy 1 . |
| 2018-09-18 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces Receipt of European Commission Approval For ILUMETRI sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that Almirall has received the European Commission (EC) approval for ILUMETRI® (tildrakizumab) for the treatment of adults with moderate -to-severe chronic plaque psoriasis who are candidates for systemic therapy. |
| 2018-07-27 | Almirall, S.A. | Regulatory Almirall receives positive CHMP opinion for new anti-IL23 tildrakizumab for the treatment of patients with moderate-to-severe chronic plaque psoriasis almirall.com ↗ |
| 2018-03-21 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces U.S. FDA Approval of ILUMYA™ (tildrakizumab-asmn) sunpharma.com ↗ |
| 2017-05-24 | Sun Pharmaceutical Industries, Inc. | Regulatory US FDA Filing Acceptance of Biologics License Application For Tildrakizumab sunpharma.com ↗
The acceptance of the regulatory filing by the U.S. FDA marks a significant milestone as we seek to advance for tildrakizumab as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis. |
| 2017-03-24 | Sun Pharmaceutical Industries, Inc. | Regulatory Almirall and Sun Pharma Announce Regulatory Filing of Tildrakizumab in Europe sunpharma.com ↗
Almirall and Sun Pharma Announce Regulatory Filing of Tildrakizumab in Europe |
| 2017-03-07 | Almirall, S.A. | Results Data from Tildrakizumab Clinical Development Program Presented at the 2017 American Academy of Dermatology Meeting almirall.com ↗
Data from the pivotal trial was presented that demonstrated the long-term efficacy of Tildrakizumab. |
| 2016-10-01 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma to Announce Late-Breaking Results for Tildrakizumab sunpharma.com ↗ |
| 2016-05-04 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Announces Positive Results of Two Pivotal Phase-3 Clinical Trials of Tildrakizumab in Patients with Moderate-to-Severe Plaque Psoriasis sunpharma.com ↗
Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, N SE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) today announce d that two pivotal Phase-3 clinical trials evaluating the effi cacy and safety of the investigational IL-23p19 inh ibitor antibody tildrakizumab (MK-3222) in patients with moderate-t o-severe plaque psoriasis met their primary endpoin ts for both evaluated doses. |
All press releases naming this drug 49 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tildrakizumab | “OBJECTIVES: To evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA).” PMID 33985942 ↗ May 202126“Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)” NCT04314531 ↗ “Tildrakizumab is an anti-interleukin-23p19 monoclonal antibody approved to treat moderate to severe plaque psoriasis.” PMID 37162744 ↗ May 2023 “tildrakizumab, an anti-interleukin-23 p19 antibody, met the primary efficacy endpoint at week 16.” PMID 39722400 ↗ Dec 2024 “Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis” NCT04991116 ↗ |
| Known as | Ilumetri | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108681 ↗ |
| Known as | Ilumya | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04347473 ↗ |
| Known as | MK-3222 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01936688 ↗ |
| Known as | SCH 900222 | “A 28-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous SCH 900222 /...” NCT01936688 ↗ |
| Known as | SUNPG18_07 I | “SUNPG18_07 I (Tildrakizumab 200 mg)” NCT03552276 ↗ |
| Known as | SUNPG18_07 II | “SUNPG18_07 II (Tildrakizumab 100 mg)” NCT03552276 ↗ |
| Known as | TIL | “Tildrakizumab (TIL), a monoclonal antibody that selectively targets interleukin-23p19, has been approved for the treatment of moderate-to-severe plaque psoriasis.” PMID 36098877 ↗ Sep 2022 |
| Known as | Tildrakizumab asmn | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108681 ↗ |
| Action | Inhibit | “Tildrakizumab is an anti-interleukin-23p19 monoclonal antibody recently approved for the treatment of chronic plaque psoriasis.” PMID 30915660 ↗ Aug 2019 |
| Modality | Monoclonal antibody | “Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial.” PMID 26042589 ↗ Oct 2015 |
| Route | Subcutaneous | “Participants were randomized to receive subcutaneous tildrakizumab (5, 25, 100, 200 mg) or placebo at weeks 0 and 4 (part I) and every 12 weeks thereafter until week 52 (part II).” PMID 26042589 ↗ Oct 2015 |