Upadacitinib ER is under clinical development by AbbVie and currently in the Phase I, Phase II, Phase III and Pre-Registration 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 Upadacitinib ER’s likelihood of approval (LoA) and phase transition for Systemic-Onset Juvenile Idiopathic Arthritis (Still Disease) took place on 10 Nov 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 Upadacitinib ER Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Upadacitinib ER overview

Upadacitinib (Rinvoq, Rim-Voq, Refu) is an antineoplastic drug, acts as immunosuppressive agent. It is formulated as extended release tablets, extended release coated tablets and extended release film coated tablets for oral route of administration. Rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis  who have had an inadequate response or intolerance to methotrexate and is indicated as monotherapy or in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs), indicated for active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and also indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Rinvoq is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable. Rinvoq is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Rinvoq is indicated for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Rinvoq is indicated for the treatment of ankylosing spondylitis, which is inadequately effective with existing treatments in adults. Rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Upadacitinib tartrate (ABT-494) is under development for the treatment of non-segmental vitiligo, moderate to severe hidradenitis suppurativa, moderately to severely active systemic lupus erythematosus, moderately to severely active rheumatoid arthritis (RA), psoriatic arthritis, Takayasu arteritis, ulcerative colitis, spondyloarthritis, juvenile idiopathic arthritis, oligoarticular idiopathic juvenile arthritis, polyarticular juvenile idiopathic arthritis, Crohn's disease in adults and pediatric patients, giant cell arteritis and ankylosing spondylitis. ABT-494 is administered through oral route as a tablet. The drug candidate targets JAK 1. It was also under development for the treatment of moderate to severe atopic dermatitis.

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 Upadacitinib ER LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Upadacitinib ER
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Dermatology
  • Gastrointestinal
  • Immunology
  • Musculoskeletal Disorders
Key Developers
  • Sponsor Company: AbbVie
  • Originator: Abbott Laboratories
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.