Dupilumab is under clinical development by Regeneron Pharmaceuticals and currently in the Phase I, 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 Dupilumab’s likelihood of approval (LoA) and phase transition for Bullous Pemphigoid took place on 24 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 24 Nov 2022 decreased Dupilumab’s LoA and PTSR for Chronic Urticaria Or Hives.

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

Dupilumab overview

Dupilumab (REGN-668, SAR231893, Dupixent, Dubrantis) is a monoclonal antibody developed based on VelocImmune technology. It is formulated as an injectable solution for subcutaneous route of administration. Dupilumab is indicated for the treatment of asthma, atopic dermatitis (atopic eczema), nasal polyps (nasal polyposis) and rhinosinusitis.  Dupixent is indicated for the treatment of adults and pediatrics patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

It is under development for the treatment of , grass pollen allergy, gastroenteritis, chronic urticaria or hives, dermatitis (eczema), prostate cancer, chronic obstructive pulmonary disease (copd), chronic bronchitis, alopecia areata, bullous pemphigoid, prurigo, systemic sclerosis (scleroderma), pruritus, allergic bronchopulmonary aspergillosis, atopic keratoconjunctivitis, asthma, immunoglobulin g4-related disease (igg4-rd), atopic dermatitis (atopic eczema) and ulcerative colitis.

It was under development for peanut allergy.

Regeneron Pharmaceuticals overview

Regeneron Pharmaceuticals (Regeneron) is engaged in discovering, developing, manufacturing, and marketing medicines for the treatment of serious medical conditions. Its products are focused on helping patients suffering from cancer, allergic and inflammatory diseases, eye diseases, metabolic and cardiovascular diseases, infectious diseases, neuromuscular diseases, and rare diseases. It develops products using its Trap and VelociSuite technology platforms, which include VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, and other related technologies. The company operates manufacturing facilities in Rensselaer, New York, and Limerick, Ireland. It also collaborates with strategic partners to develop, manufacture, and commercialize its products. It sells its products to specialty pharmacies and distributors. The company operates in the US, the Netherlands, Bermuda, Ireland, Spain, and the UK. Regeneron is headquartered in Tarrytown, New York, the US.

Quick View Dupilumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Dupilumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Dermatology
  • Ear Nose Throat Disorders
  • Gastrointestinal
  • Immunology
  • Infectious Disease
  • Oncology
  • Ophthalmology
  • Respiratory
Key Developers
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.