Drugs / Depemokimab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma, nasal polyps, and aspirin intolerance 3 milestones | |||||
| Filed | US (FDA) | — | asthma, nasal polyps, and aspirin intolerance | 2025-03-03 | “the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications.” gsk.com ↗ |
| Filed | EU (EMA) | — | asthma, nasal polyps, and aspirin intolerance | 2025-01-28 | “European Medicines Agency has accepted for review the Marketing Authorisation Application for the use of depemokimab in two indications.” gsk.com ↗ |
| Filed | Japan (PMDA) | — | asthma, nasal polyps, and aspirin intolerance | 2025-01-28 | “submitted to the Japanese Ministry of Health, Labour and Welfare for use of depemokimab in two indications.” gsk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Exdensur | — | 2026-02-12 | europa.eu ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05602025 | Dec 2022 → Oct 2023 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT05140200 | Dec 2021 → Dec 2022 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT03287310 | Oct 2017 → Jul 2019 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 314 trials · 4 met primary | ||||||
| Phase 3 | NCT07671001 | Jun 2026 → Mar 2029 expected | asthma | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07456033 | Mar 2026 → Jul 2030 expected | asthma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT07177339 | Oct 2025 → Nov 2029 expected | chronic obstructive pulmonary disease | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06961214 | Jun 2025 → Dec 2028 expected | chronic obstructive pulmonary disease | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06959095 | Jun 2025 → Dec 2028 expected | chronic obstructive pulmonary disease | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06979323 | Jul 2024 → Jan 2028 expected | asthma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05334368 | Sep 2022 → Nov 2027 expected | hypereosinophilic syndrome | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05263934 | Jul 2022 → Sep 2026 overdue | eosinophilic granulomatosis with polyangiitis | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05274750 | Apr 2022 → Jul 2024 | nasal cavity polyp | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT05281523 | Apr 2022 → Jul 2024 | nasal cavity polyp | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT05243680 | Mar 2022 → May 2025 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04719832 | Mar 2021 → Nov 2023 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT04718103 | Feb 2021 → Apr 2024 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT04718389 | Jan 2021 → Sep 2025 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07701967 | Jul 2026 → Jun 2027 expected | nasal cavity polyp | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07828327 | Nov 2026 → Feb 2027 expected | allergic bronchopulmonary aspergillosis, chronic asthma | Qianfoshan Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-04-08 | GlaxoSmithKline | Regulatory Exdensur (depemokimab) approved in China for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. |
| 2026-03-30 | GlaxoSmithKline | Regulatory Exdensur (depemokimab) approved in China for the treatment of severe asthma gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older. |
| 2026-02-17 | GlaxoSmithKline | Regulatory Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the European Commission has approved Exdensur (depemokimab) in two indications: as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller; as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. |
| 2026-01-06 | GlaxoSmithKline | Regulatory Exdensur (depemokimab) approved in Japan for severe asthma and chronic rhinosinusitis with nasal polyps gsk.com ↗
The MHLW approval was based on data from the SWIFT and ANCHOR phase III trials, which demonstrated the sustained efficacy of a twice-yearly dose of depemokimab versus placebo, both plus standard of care. |
| 2025-12-16 | GlaxoSmithKline | Regulatory Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older. |
| 2025-12-15 | GlaxoSmithKline | Regulatory Exdensur (depemokimab) approved in the UK for treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the marketing authorisation of Exdensur (depemokimab) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). |
| 2025-12-12 | GlaxoSmithKline | Regulatory Depemokimab receives positive CHMP opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps gsk.com ↗ |
| 2025-03-03 | GlaxoSmithKline | Regulatory Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP) gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications. |
| 2025-03-01 | GlaxoSmithKline | Results Depemokimab delivers clinically meaningful and statistically significant improvements for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) gsk.com ↗
ANCHOR-1 (N=271) and ANCHOR-2 (N=257) met their co-primary endpoints, with twice-yearly administration of depemokimab showing clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction, two key clinical measures of disease severity, versus placebo. |
| 2025-01-28 | GlaxoSmithKline | Regulatory Depemokimab applications accepted for review in China and Japan for asthma with type 2 inflammation and CRSwNP gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that new drug applications have been accepted for review by the China National Medical Products Administration and submitted to the Japanese Ministry of Health, Labour and Welfare for use of depemokimab in two indications. |
| 2025-01-28 | GlaxoSmithKline | Regulatory Depemokimab accepted for review by the European Medicines Agency for use in asthma with type 2 inflammation and CRSwNP gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency has accepted for review the Marketing Authorisation Application for the use of depemokimab in two indications. |
| 2024-10-14 | GlaxoSmithKline | Results GSK announces positive phase III results from ANCHOR trials for depemokimab in chronic rhinosinusitis with nasal polyps gsk.com ↗
Both trials met their co-primary endpoints of a change from baseline in total endoscopic nasal polyp score at 52 weeks and change from baseline in mean nasal obstruction score from weeks 49 to 52. |
| 2024-09-09 | GlaxoSmithKline | Results Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations gsk.com ↗
SWIFT-1 and SWIFT-2 phase III data show depemokimab delivered a statistically significant and clinically meaningful reduction in exacerbations over 52 weeks versus placebo plus standard of care, in duplicate studies |
| 2024-09-03 | GlaxoSmithKline | Results GSK aims to redefine the future of respiratory medicine at the European Respiratory Society International Congress gsk.com ↗
First presentation of SWIFT-1 and SWIFT-2 phase III trial data for ultra-long-acting biologic depemokimab in severe asthma |
| 2024-05-21 | GlaxoSmithKline | Results GSK announces positive results from phase III severe asthma trials of depemokimab gsk.com ↗
Both SWIFT-1 and SWIFT-2 met their primary endpoints of a reduction in the annualised rate of clinically significant exacerbations (asthma attacks) over 52 weeks. |
All press releases naming this drug 15 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Depemokimab | “GSK3511294 (Depemokimab) 100 mg SC along with the placebo and SOC will be administered.” NCT04718389 ↗16“GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.” NCT05243680 ↗ |
| Known as | AQ-82742999 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650469 ↗ |
| Known as | GSK3511294 | “Depemokimab (GSK3511294) was administered using a pre- filled syringe.” NCT05274750 ↗6“Depemokimab (GSK3511294) was administered using a pre-filled syringe.” NCT05281523 ↗ “GSK3511294 (Depemokimab)” NCT04719832 ↗ |
| Action | Inhibit | “known to block binding of IL-5 to the IL-5 receptor complex” NCT03287310 ↗ |
| Modality | Monoclonal antibody | “GSK3511294 is a humanized anti-interleukin (IL)-5 monoclonal antibody (mAb)” PMID 34292606 ↗ Aug 2021 |
| Route | Subcutaneous | “GSK3511294 will be administered by SC injection.” NCT03287310 ↗ |
| Target | IL5 | “GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5” NCT03287310 ↗ |