Drug Profile

Dupilumab - Regeneron/Sanofi

Alternative Names: Dupilumab-Sanofi/Regeneron; Dupixent; REGN-668; SAR-231893

Latest Information Update: 24 Sep 2025

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At a glance

Originator Regeneron Pharmaceuticals; sanofi-aventis
Developer Aimmune Therapeutics; Mayo Clinic; Regeneron Pharmaceuticals; Sanofi; Sanofi-Aventis GmbH
Class Anti-inflammatories; Antiallergics; Antiasthmatics; Antifungals; Antineoplastics; Antipruritics; Immunotherapies; Monoclonal antibodies; Skin disorder therapies
Mechanism of Action Interleukin 13 receptor antagonists; Interleukin 4 receptor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Bullous pemphigoid; Eosinophilic oesophagitis
New Molecular Entity Yes

Marketed Asthma; Atopic dermatitis; Chronic obstructive pulmonary disease; Chronic urticaria; Eosinophilic oesophagitis; Prurigo nodularis; Rhinosinusitis
Registered Bullous pemphigoid
Phase III Pruritus; Wheezing
Phase II/III Eosinophilic gastroenteritis
Phase II Aspergillosis; Eczema; Prostate cancer; Ulcerative colitis; Urticaria
No development reported Allergic asthma
Discontinued Grass pollen hypersensitivity; Peanut hypersensitivity

22 Sep 2025 Regeneron Pharmaceuticals anticipates a final decision from EC in the coming months
22 Sep 2025 The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion for Dupilumab in Chronic urticaria in patients with aged 12 years and above
08 Aug 2025 Regeneron Pharmaceuticals plans a phase III expanded access trial for Eosinophilic-oesophagitis (In Infants, In children) in January 2026 (NCT07112378)

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