Drug Type Monoclonal antibody |
Synonyms Dupilumab (Genetical Recombination), Dupilumab (genetical recombination) (JAN), Dupilumab (USAN) + [10] |
Target |
Action inhibitors |
Mechanism IL-4Rα inhibitors(Interleukin-4 receptor subunit alpha inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (28 Mar 2017), |
RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Priority Review (United States), Breakthrough Therapy (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pulmonary Disease, Chronic Obstructive | European Union | 03 Jul 2024 | |
Pulmonary Disease, Chronic Obstructive | Iceland | 03 Jul 2024 | |
Pulmonary Disease, Chronic Obstructive | Liechtenstein | 03 Jul 2024 | |
Pulmonary Disease, Chronic Obstructive | Norway | 03 Jul 2024 | |
Chronic Urticaria | Japan | 09 Feb 2024 | |
Chronic Urticaria | Japan | 09 Feb 2024 | |
Eosinophilic Esophagitis | Canada | 06 Feb 2018 | |
prurigo nodularis | Australia | 24 Jan 2018 | |
Asthma | European Union | 26 Sep 2017 | |
Asthma | Iceland | 26 Sep 2017 | |
Asthma | Liechtenstein | 26 Sep 2017 | |
Asthma | Norway | 26 Sep 2017 | |
Chronic rhinosinusitis with nasal polyps | European Union | 26 Sep 2017 | |
Chronic rhinosinusitis with nasal polyps | Iceland | 26 Sep 2017 | |
Chronic rhinosinusitis with nasal polyps | Liechtenstein | 26 Sep 2017 | |
Chronic rhinosinusitis with nasal polyps | Norway | 26 Sep 2017 | |
Dermatitis, Atopic | United States | 28 Mar 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Pemphigoid, Bullous | NDA/BLA | United States | 18 Feb 2025 | |
Pemphigoid, Bullous | NDA/BLA | United States | 18 Feb 2025 | |
Eosinophilic Duodenitis | Phase 3 | United States | 03 May 2023 | |
Eosinophilic Duodenitis | Phase 3 | United States | 03 May 2023 | |
Eosinophilic Duodenitis | Phase 3 | Japan | 03 May 2023 | |
Eosinophilic Duodenitis | Phase 3 | Japan | 03 May 2023 | |
Eosinophilic Duodenitis | Phase 3 | Australia | 03 May 2023 | |
Eosinophilic Duodenitis | Phase 3 | Australia | 03 May 2023 | |
Eosinophilic Duodenitis | Phase 3 | Canada | 03 May 2023 | |
Eosinophilic Duodenitis | Phase 3 | Canada | 03 May 2023 |
Phase 3 | 935 | Inhaled Corticosteroid | ckgexmaspe = mvvxbkyipi kiewdidtgl (jjlahpmocr, xealqihorc - udiwrkyltg) View more | - | 17 Mar 2025 | ||
Phase 4 | - | Dupilumab 300 mg | bwgdvxthgz(ulsqiocyaa) = hbzhjajhwi wcgazgdyfw (jcuqnryxnz ) | Positive | 01 Mar 2025 | ||
Placebo | bwgdvxthgz(ulsqiocyaa) = jduhhxrmso wcgazgdyfw (jcuqnryxnz ) | ||||||
Phase 3 | 414 | Dupilumab 200 mg | qjpjlcozuc(nsibxxsbgn) = xlxrjehpdb ifdkxkcraw (msxjtknxvj, 0.23 - 0.39) | Positive | 23 Feb 2025 | ||
Placebo | - | ||||||
Phase 3 | Add-on | - | Dupilumab 300 mg | bnwhcesdtm(rwvrjngelz) = zeuwhrxzkj zsozayqptx (xedhxcxtix ) View more | Positive | 01 Jan 2025 | |
Placebo | bnwhcesdtm(rwvrjngelz) = lhyvzysizn zsozayqptx (xedhxcxtix ) View more | ||||||
Phase 3 | 71 | (Dupilumab 300 mg q2w) | xydpdemaeh(dqgprrfeks) = jzamiyvlkb rzdwokqpps (pfwfcdrmjt, 3.91) View more | - | 18 Dec 2024 | ||
placebo (Placebo) | ggyxwayprh(rswoytuqid) = vfpgdlfxnb cvooqhgzct (ndzolozpnd, 2.26) View more | ||||||
NCT03346434 (Pubmed) Manual | Phase 2/3 | - | giklflwssg(aubalixlku) = Significantly more patients receiving dupilumab versus placebo with FAs and numerically more patients without FAs achieved an IGA score of 0/1 (p = 0.0007 and p = 0.06). whinmcfydn (ngwsapnzjw ) View more | Positive | 01 Dec 2024 | ||
Placebo | |||||||
Phase 4 | 202 | Placebo | gfrbagypvy(owhmqzpcrw) = oqntbrovbp gyfmkemnwj (jxytybgiti, 0.077) View more | - | 26 Nov 2024 | ||
Not Applicable | - | zrglhbzsux(dhpqiaiczf) = One patient with high-titer ADAs developed serum sickness nfxwyowjuh (njpxzvhxyq ) | - | 11 Nov 2024 | |||
Phase 3 | 174 | ekkmlkryij(vfekdkmyyh) = The incidence of treatment emergent adverse events was similar with dupilumab and placebo mohlfrrstu (qqugonuixq ) | Positive | 01 Nov 2024 | |||
Phase 3 | 151 | usyitxusmm(lqheyfyikd) = xowfbiufcd oatweseqti (iavnmxzpqn ) View more | Positive | 24 Oct 2024 | |||
Placebo | usyitxusmm(lqheyfyikd) = olpuwtqfhg oatweseqti (iavnmxzpqn ) View more |