Risankizumab is under clinical development by AbbVie and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Risankizumab’s likelihood of approval (LoA) and phase transition for Ulcerative Colitis took place on 17 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Risankizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Risankizumab overview

Risankizumab (Skyrizi) is a humanized monoclonal antibody, acts as an immunosuppressant agent. It is formulated as solution, concentrate solution for subcutaneous and intravenous route of administration. Skyrizi is indicated for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. Skyrizi is indicated for: the treatment of adult patients with active psoriatic arthritis. Skyrizi can be used alone or in combination with a conventional non-biologic diseasemodifying antirheumatic drug (cDMARD) (e.g., methotrexate). Skyrizi is indicated for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies.

Risankizumab (BI-655066) is under development for the treatment of palmoplantar pustulosis, moderate to severe Crohn's disease, atopic dermatitis, ulcerative colitis and moderate to severe chronic plaque psoriasis with or without psoriatic arthritis, psoriatic erythroderma. BI-655066 is administered through subcutaneous and intravenous route. BI655066 is a humanized IgG1 monoclonal antibody that binds and neutralizes the p19 subunit of IL-23. It was also under development for ankylosing spondylitis.

It was under development for the treatment of moderate to severe hidradenitis suppurativa, asthma and pustular psoriasis.

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic diseases, rheumatological diseases, neurological disorders, viral diseases, skin diseases, complications associated with cystic fibrosis, pain related to endometriosis, diseases of the gastrointestinal tract, various types of cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of cystic fibrosis, women’s health, various cancers, neurological disorders and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, health care facilities, government agencies, specialty pharmacies and independent retailers through its own distribution centers and public warehouses worldwide. AbbVie is headquartered in North Chicago, Illinois, the US.

Quick View Risankizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Risankizumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Dermatology
  • Gastrointestinal
  • Immunology
  • Musculoskeletal Disorders
  • Respiratory
Key Developers
  • Sponsor Company: AbbVie
  • Originator: Boehringer Ingelheim International
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.