Opzelura is under clinical development by Incyte and currently in Phase II for Graft Versus Host Disease (GVHD). According to GlobalData, Phase II drugs for Graft Versus Host Disease (GVHD) have a 48% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Opzelura’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Opzelura overview
Ruxolitinib phosphate (Opzelura) is an anti neoplastic, immunomodulating and anti inflammatory agent. It is formulated as cream for topical application. Opzelura is indicated for the topical short term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Ruxolitinib phosphate (INCB-018424) is under development for the treatment of prurigo nodularis (PN), graft versus host disease, discoid lupus erythematosus, vitiligo and atopic dermatitis, hand dermatitis, vitiligo, vulvar lichen sclerosus, unspecified dermatological disorders, hidradenitis suppurativa, seborrhea.
It was under development for the treatment of alopecia areata and plaque psoriasis.
Incyte overview
Incyte is a biopharmaceutical company, which discovers, develops and commercializes proprietary cancer therapeutics. The company’s lead product, Jakafi (ruxolitinib) is marketed in the US for the treatment of patients with high-risk myelofibrosis; and polycythemia vera who are intolerant to hydroxyurea. The company distributes Jakafi through a network of specialty pharmacy providers and wholesalers. In collaboration with Incyte, Novartis International Pharmaceutical Ltd (Novartis) develops and commercializes ruxolitinib outside the US for hematologic and cancer indications under the name Jakavi. The company’s pipeline portfolio encompasses drugs for the treatment of lung cancer, graft versus host disease, b-cell malignancies, solid tumors, non-small cell lung cancer, glioblastoma, liver cancer, and advanced malignancies. Incyte is headquartered in Wilmington, Delaware, the US.
For a complete picture of Opzelura’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
