|Source||Humanized (from mouse)|
|Chemical and physical data|
|Molar mass||144436.68 g·mol−1|
Tildrakizumab (trade name Ilumya (USA)/Ilumetri (European Union)) is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. In the United States, it is approved for the treatment of moderate-to-severe plaque psoriasis.
In September 2014 Sun Pharmaceutical acquired worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of US$80 million. Upon product approval, Sun Pharmaceutical will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.
In 2016, tildrakizumab became the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials for the treatment of moderate-to-severe plaque psoriasis, further validating the importance of the role of IL-23 in psoriasis. Sun Pharma signed a licensing pact with Spain's Almirall for marketing tildrakizumab in Europe.
Approvals and indications
In March 2018, it was approved by the Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis as an injection for subcutaneous use in the United States. In September 2018, it was approved by the European Commission for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy.
- Guselkumab, another experimental, IL-23-specific monoclonal antibody (FDA approved in 2017)
- Risankizumab, another experimental, IL-23-specific monoclonal antibody (FDA approved in 2019)
- Ustekinumab, a monoclonal antibody targeting both IL-12 and IL-23 and used to treat plaque psoriasis, launched in the United States under the brand name Stelara
- "Statement on a Nonproprietary Name Adopted by the USAN Council—Tildrakizumab", American Medical Association.
- "FDA approves Ilumya for plaque psoriasis". National Psoriasis Foundation. March 22, 2018.
- "Sun Pharma and Merck & Co. Inc. Enter into Licensing Agreement for Tildrakizumab" (Press release). Merck. 17 September 2014. Archived from the original on 12 March 2015.
- "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) - Full Text View". ClinicalTrials.gov.
- "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) - Full Text View". ClinicalTrials.gov.
- "Sun Pharma signs licensing pact with Spain's Almirall for tildrakizumab in Europe". Business Standard. BS B2B Bureau. 28 July 2016.
- "Almirall: The European Commission approves Almirall's ILUMETRI® (tildrakizumab) for moderate-to-severe chronic plaque psoriasis". Retrieved 23 September 2018.
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