Tildrakizumab

Tildrakizumab is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders.^[1]

Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune disease. Originally developed by Schering-Plough, this drug is now part of Merck's clinical program, following that company's acquisition of Schering-Plough.

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. ^[2]

As of March 2014, the drug was in phase III clinical trials for plaque psoriasis. The two trials enrolled nearly 2000 patients. ^[3][4]

In 2016, Tildrakizumab becomes 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 ^[5]

See also

• 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

References

1. ↑ Statement On A Nonproprietary Name Adopted By The USAN Council - Tildrakizumab, American Medical Association.
2. ↑ http://www.merck.com/licensing/our-partnership/sunpharma_partnership.html
3. ↑ http://clinicaltrials.gov/ct2/show/NCT01729754?term=SCH-900222&phase=2&fund=2&rank=1
4. ↑ http://clinicaltrials.gov/ct2/show/NCT01722331?term=SCH-900222&phase=2&fund=2&rank=2
5. ↑ http://www.business-standard.com/content/b2b-pharma/sun-pharma-signs-licensing-pact-with-spain-s-almirall-for-tildrakizumab-in-europe-116072800225_1.html