Tildrakizumab

From Wikipedia, the free encyclopedia
Jump to navigation Jump to search
Tildrakizumab
Monoclonal antibody
Type Whole antibody
Source Humanized (from mouse)
Target IL23
Clinical data
Trade names Ilumya
Synonyms Tildrakizumab-asmn
Routes of
administration
Subcutaneous injection
ATC code
  • none
Identifiers
CAS Number
ChemSpider
  • none
KEGG
Chemical and physical data
Formula C6426H9918N1698O2000S46
Molar mass 144.4 kg/mol

Tildrakizumab (trade name Ilumya) is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders.[1] In the United States, it is approved for the treatment of moderate-to-severe plaque psoriasis.[2]

Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune disease.

History[edit]

Originally developed by Schering-Plough, this drug became part of Merck's clinical program, following that company's acquisition of Schering-Plough.[when?]

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 U.S. $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. [3]

As of March 2014, the drug was in phase III clinical trials for plaque psoriasis. The two trials enrolled nearly 2000 patients. [4][5]

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 [6]

Approvals and indications[edit]

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.[2]

See also[edit]

  • 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
  • Guselkumab, another experimental, IL-23-specific monoclonal antibody. (FDA approved in 2017)
  • Risankizumab, another experimental, IL-23-specific monoclonal antibody. (In Phase 3 clinical trials for plaque psoriasis as of 2017)

References[edit]