Tildrakizumab

Tildrakizumab (trade name Ilumya (USA)/Ilumetri (European Union)) 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
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetIL23
Clinical data
Trade namesIlumya
Other namesTildrakizumab-asmn
Routes of
administration
Subcutaneous injection
ATC code
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6426H9918N1698O2000S46
Molar mass144436.68 g·mol−1

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

History

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

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.[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

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] 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.[7]

See also

  • 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

References

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