Dupilumab is a human monoclonal antibody marketed as Dupixent for multiple allergic and inflammatory diseases including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and COPD. It works by blocking IL-4/IL-13 signaling pathways via IL-4 receptor alpha antagonism. The drug is prescription-only and has received multiple indication expansions after initial U.S. approval in 2017.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Novartis received EU approval for Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria. Phase 3 data also showed significant efficacy in chronic inducible urticaria, with filings underway for additional indications.
Sanofi has submitted a revised acquisition bid for Ocular Therapeutix ahead of pivotal Phase 3 trial results for AXPAXLI, a sustained-release treatment for wet AMD. The deal could position Sanofi to re-enter the ophthalmology market it previously abandoned. The acquisition would give Sanofi access to innovative hydrogel delivery technology with potential applications beyond eye disease.
Regeneron has consistently increased revenue over 35 years with blockbuster products like Dupixent and Eylea HD, while maintaining over a dozen phase 3 clinical trial candidates across multiple therapeutic areas.
Sanofi receives FDA approval for Dupixent to treat allergic fungal rhinosinusitis and gains European endorsement for Acoziborole Winthrop as a sleeping sickness treatment, which will be donated to WHO.
Researchers at Icahn School of Medicine at Mount Sinai found that major depressive disorder shares key immune abnormalities with atopic dermatitis, particularly Th2 pathway activation. The team plans to test dupilumab in a clinical trial for depression.
Major pharmaceutical companies are highlighting their drug pipelines to offset upcoming patent losses, while Moderna confronts FDA rejection of its flu vaccine. The industry faces significant revenue challenges from patent cliffs in 2026.
Sanofi replaced CEO Paul Hudson with Belén Garijo from Merck KGaA after a stalled turnaround. The company faces pressure to develop drugs to replace blockbuster Dupixent and navigate U.S. vaccine skepticism.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07386743 |
A Phase III Study of GS101 Injection to Dupixent® |
NOT_YET_RECRUITING | PHASE3 |
| NCT07268313 |
Complete Remission After Treatment With Biologics for Nasal Polyps |
RECRUITING | PHASE4 |
| NCT06884891 |
A Phase Ⅲ Comparative Study of QL2108 to Dupixent® |
NOT_YET_RECRUITING | PHASE3 |
| NCT06614907 |
A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent® |
COMPLETED | PHASE1 |
| NCT05470114 |
A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD |
COMPLETED | PHASE2 |
| NCT04959448 |
Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) |
ACTIVE_NOT_RECRUITING | |
| NCT04502966 |
Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction |
COMPLETED | PHASE2 |
| NCT04287621 |
Registry of Asthma Patients Initiating DUPIXENT® |
ACTIVE_NOT_RECRUITING |
