Overview
Tildrakizumab is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis . The Food and Drug Administration (FDA) approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in March 2018. The approved recommended dosage of ILUMYA is a subcutaneous injection of 100 mg at Weeks 0, 4, and every 12 weeks thereafter . A study was performed on the pharmacokinetics of this drug on various ethnicities. The pharmacokinetics of tildrakizumab were similar in Japanese, Caucasian, and Chinese subjects .
Background
Tildrakizumab is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis . The Food and Drug Administration (FDA) approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in March 2018. The approved recommended dosage of ILUMYA is a subcutaneous injection of 100 mg at Weeks 0, 4, and every 12 weeks thereafter . A study was performed on the pharmacokinetics of this drug on various ethnicities. The pharmacokinetics of tildrakizumab were similar in Japanese, Caucasian, and Chinese subjects .
Indication
Moderate-severe plaque psoriasis , .
Associated Conditions
- Moderate to Severe Plaque Psoriasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/24 | Phase 3 | Recruiting | |||
2024/07/05 | N/A | Active, not recruiting | |||
2023/09/08 | N/A | Recruiting | |||
2023/09/08 | N/A | Recruiting | |||
2022/05/25 | Phase 4 | Recruiting | |||
2021/11/05 | Phase 3 | Completed | |||
2021/07/21 | Early Phase 1 | Completed | Premier Specialists, Australia | ||
2021/03/30 | N/A | Completed | |||
2020/07/10 | Early Phase 1 | UNKNOWN | |||
2020/07/07 | Phase 1 | Terminated | Institute of Cancer Research, United Kingdom |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | 47335-177 | SUBCUTANEOUS | 100 mg in 1 mL | 4/17/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/17/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ILUMYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/ML | SIN17076P | INJECTION, SOLUTION | 100mg/mL | 9/4/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tildrakizumab Injection | 国药准字SJ20230006 | 生物制品 | 注射剂 | 5/26/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ILUMYA tildrakizumab (rch) 100 mg/1 mL solution for injection pre-filled syringe | 290683 | Medicine | A | 9/10/2018 |