tildrakizumab
Trade name: Ilumetri
mAbapproved
Approved
Mar 20, 2018
Tildrakizumab, sold under the brand name Ilumya among others, is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. It is approved for the treatment of adults with moderate-to-severe plaque psoriasis in the United States and in the European Union. — Wikipedia
Clinical trial activity
29 trials · 19 clinical orgs · 2 marketing orgs
Phase 1
3
Phase 2
15
Phase 3
12
Phase 4
10
Earliest trial started Oct 1, 2010 (NCT01225731)
Timeline
2010s
- Jan 1, 2010
- Jan 1, 2012
- Mar 20, 2018
Merck — Earliest FDA Approval
- Mar 20, 2018
Sun Pharmaceuticals — Marketing Organization
- Mar 20, 2018
Merck — NDA Organization
- Mar 20, 2018
Sun Pharmaceuticals — NDA Secondary Org
2020s
- Jan 1, 2020
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Aging · Phase 4
- Arthritis, Psoriatic · Phase 3
- Biological Products · Early Phase 1
- Cardiovascular Diseases · Phase 4
- Genetic Diseases, Inborn · Phase 4
- Hematologic Neoplasms · Phase 2
- Hypopigmentation · Early Phase 1
- Inflammation · Phase 4
- Pemphigoid, Bullous · Early Phase 1
- Pigmentation Disorders · Early Phase 1
- Prostatic Neoplasms, Castration-Resistant · Phase 1/Phase 2
- Psoriasis · Phase 4
- Skin and Connective Tissue Diseases · Early Phase 1
- Skin Diseases · Early Phase 1
- Spondylitis, Ankylosing · Phase 2
- Vitiligo · Early Phase 1
Mechanism of action
- Interleukin-23 subunit alphaINHIBITOR
IL23A inhibitor
- Interleukin-37INHIBITOR
IL37 inhibitor
- Interleukin-23INHIBITOR
Interleukin-23 inhibitor
Alpha (p19) subunit is binding site
Approval history
- approvedMar 20, 2018
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaTildrakizumab ↗
- NCATSDEW6X41BEK ↗
- ChEMBLCHEMBL2108681 ↗
Also known as
- mk-3222
- mk-3222
- sch 900222
- tildrakizumab
- tildrakizumab
- tildrakizumab
- tildrakizumab-asmn
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06611163 | Phase 3 | Nov 30, 2024 | Sun Pharmaceuticals |
| NCT05390515 | Phase 4 | Sep 1, 2022 | Sun Pharmaceuticals, University of California, San Francisco |
| NCT04991116 | Phase 3 | Jan 31, 2022 | Sun Pharmaceuticals |
| NCT05110313 | Phase 4 | Nov 1, 2021 | Brown University, Department of Veteran Affairs, Rhode Island Hospital, Sun Pharmaceuticals |
| NCT04971200 | Early Phase 1 (Phase 1) | Jul 31, 2021 | Premier Specialists, Australia, University of New South Wales |
| NCT05108766 | Phase 3 | Dec 17, 2020 | Shenzhen Kangzhe Pharmaceutical Co., Ltd. |
| NCT04458311 | Phase 1/Phase 2 (Phase 2) | Dec 1, 2020 | National Health Service, United Kingdom, Sun Pharmaceuticals, University of London |
| NCT04541329 | Phase 4 | Sep 10, 2020 | Sun Pharmaceuticals, University of California, San Francisco |
| NCT04465292 | Early Phase 1 (Phase 1) | Sep 1, 2020 | Harvard University |
| NCT04340076 | Phase 4 | May 31, 2020 | Ghent University, Katholieke Universiteit Leuven, Radboud University, ZonMw: The Netherlands Organisation for Health Research and Development |
| NCT04314544 | Phase 3 | May 12, 2020 | Sun Pharmaceuticals |
| NCT04314531 | Phase 3 | May 12, 2020 | Sun Pharmaceuticals |
| NCT04347473 | Phase 4 | Apr 6, 2020 | Sun Pharmaceuticals, Windsor Dermatology |
| NCT04271540 | Phase 4 | Mar 31, 2020 | Harvard University |
| NCT04339595 | Phase 4 | Jan 29, 2020 | Almirall |
| NCT04229836 | Phase 4 | Dec 17, 2019 | Almirall |
| NCT04112810 | Phase 2 | Nov 1, 2019 | Medical College of Wisconsin |
| NCT04263610 | Phase 4 | Sep 4, 2019 | Almirall |
| NCT03997786 | Phase 2/Phase 3 (Phase 3) | Aug 1, 2019 | Sun Pharmaceuticals |
| NCT03897075 | Phase 3 | Jul 31, 2019 | Sun Pharmaceuticals |
Showing 20 of 29 trials
Page 1 / 2
Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sun Pharmaceuticals | For profit | 16 | 11 | 3 | 2017 |
| Merck | For profit | 4 | 4 | 2 | 2010 |
| Almirall | For profit | 3 | 3 | 1 | 2019 |
| Harvard University | Academic/Hospital | 2 | 2 | 2 | 2020 |
| University of California, San Francisco | Academic/Hospital | 2 | 2 | 1 | 2020 |
| Brown University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Department of Veteran Affairs | Government | 1 | 0 | 1 | 2021 |
| Ghent University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Katholieke Universiteit Leuven | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Medical College of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2019 |
| National Health Service, United Kingdom | Government | 1 | 0 | 1 | 2020 |
| Premier Specialists, Australia | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Radboud University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Rhode Island Hospital | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Shenzhen Kangzhe Pharmaceutical Co., Ltd. | For profit | 1 | 1 | 1 | 2020 |
| University of London | Academic/Hospital | 1 | 1 | 1 | 2020 |
| University of New South Wales | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Windsor Dermatology | Academic/Hospital | 1 | 1 | 1 | 2020 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Academic/Hospital | 1 | 0 | 1 | 2020 |
19 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Merck | For profit | NDA | Mar 20, 2018 |
| Sun Pharmaceuticals | For profit | MKTG | Mar 20, 2018 |
| Sun Pharmaceuticals | For profit | NDA2 | Mar 20, 2018 |