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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| 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 |
| Phase 24 trials | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT02980692 | Apr 2017 → Mar 2019 | psoriatic arthritis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01225731 | Oct 2010 → Nov 2011 | psoriasis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT05108766 | Dec 2020 → Jun 2021 | psoriasis | Shenzhen Kangzhe Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04314531 | Jul 2020 → Jun 2025 overdue | psoriatic arthritis | Sun Pharmaceutical Industries, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03897088 | Mar 2019 → Feb 2022 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01722331 | Dec 2012 → Oct 2015 | psoriasis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04339595 Background | Jan → Jul 2020 | psoriasis | Almirall, S.A. | Terminated | No outcome recorded |
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 |