Drug Profile

Dupilumab - Regeneron/Sanofi

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

Latest Information Update: 01 Dec 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

25 Nov 2025 Registered for Chronic-urticaria (In adults, In adolescents, In the elderly, Treatment-experienced) in European Union, Iceland, Norway, Liechtenstein (SC)
07 Nov 2025 Preregistration for Rhinosinusitis (In adolescents, In children, In the elderly, In adults) in USA (SC)
07 Nov 2025 FDA assigns PDUFA action date of 28/02/2026 for dupilumab for Rhinosinusitis (In adolescents, In adults, In children, In the elderly)

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