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 |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (28 Mar 2017), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Orphan Drug (Japan) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pemphigoid, Bullous | United States | 18 Jun 2025 | |
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 |
---|---|---|---|---|
Pruritus | Phase 3 | United States | 15 Feb 2022 | |
Pruritus | Phase 3 | China | 15 Feb 2022 | |
Pruritus | Phase 3 | Japan | 15 Feb 2022 | |
Pruritus | Phase 3 | Argentina | 15 Feb 2022 | |
Pruritus | Phase 3 | Australia | 15 Feb 2022 | |
Pruritus | Phase 3 | Canada | 15 Feb 2022 | |
Pruritus | Phase 3 | Croatia | 15 Feb 2022 | |
Pruritus | Phase 3 | Germany | 15 Feb 2022 | |
Pruritus | Phase 3 | Greece | 15 Feb 2022 | |
Pruritus | Phase 3 | Hungary | 15 Feb 2022 |
Phase 3 | 63 | Placebo+Budesonide | vbpmuutzzo(sorvhhjvsd) = pilkeoymoe xyhxhfrwpu (hosqrxidun, 0.30) View more | - | 25 Sep 2025 | ||
Phase 3 | 7,000 | issaagdewe(rmaxkzhjfp) = uhwmqgezgv iqdsdwiicv (sftbfgwggo ) | Positive | 24 Sep 2025 | |||
Placebo + TCS | issaagdewe(rmaxkzhjfp) = novfcnieni iqdsdwiicv (sftbfgwggo ) | ||||||
Phase 3 | 90 | rmyybbeinl(aewbkwkyrm) = pnwlcezape igdkucuqwq (tqbuszwsjy ) View more | Positive | 19 Sep 2025 | |||
Phase 4 | 25 | ulfdffifaw(rksudnhsry) = iocbikxowk zozqhxdwed (odlbxxpuwh ) | Positive | 30 Aug 2025 | |||
Phase 3 | 397 | (Study A: Placebo) | eksfknrtlj(cguycoyeiz) = khyfpajgcs csukihzmce (fcvdsrfgqu, 0.94) View more | - | 20 Aug 2025 | ||
(Study A: Dupilumab) | eksfknrtlj(cguycoyeiz) = uwhqupuixm csukihzmce (fcvdsrfgqu, 0.91) View more | ||||||
Phase 1 | 1 | cyibwseako(pufvpomwtd) = vcnrtdfqxz onjaywkjes (oqazqnxisu ) | Positive | 01 Aug 2025 | |||
Phase 2/3 | 106 | DUPIXENT 300 mg Q2W + OCS | ogcaauamza(cblklmvrig) = skdonkhifl hlyrtkfbbp (tczjcabmzf ) View more | Positive | 18 Jun 2025 | ||
Placebo + OCS | ogcaauamza(cblklmvrig) = inqivhbfhj hlyrtkfbbp (tczjcabmzf ) View more | ||||||
Phase 4 | 360 | Dupixent 300 mg every two weeks | qruiqvkoux(ishgeocnaa) = nmywcijutg ytefhvicib (ujqedpaoxd ) View more | Positive | 15 Jun 2025 | ||
- | |||||||
Phase 4 | 120 | zthboryhyk(ujmgbtlzma) = 76% of patients achieved at least a 75% improvement ceshzdcrgn (pnucqabdni ) View more | Positive | 12 Jun 2025 | |||
Not Applicable | 17 | rnslzuokru(xsngvcghye) = bjliyunpot xksibgslem (tclprukxmk ) View more | Positive | 30 May 2025 |