Drugs / Pozelimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | protein-losing enteropathy | 2023-02-03 | “A BLA for pozelimab, an antibody to C5, for the treatment of CD55-deficient protein-losing enteropathy (CHAPLE) was submitted.” regeneron.com ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06479863 | Aug 2024 → May 2027 expected | idiopathic inflammatory myopathy, inclusion body myositis | Austin Neuromuscular Center | Recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07230834 | Jan 2026 → Jul 2028 expected | dry age related macular degeneration | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT04940364 | Aug 2021 → Jun 2022 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04601844 | Nov 2020 → Jul 2021 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04491838 | Aug 2020 → Mar 2021 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03115996 | May 2017 → Aug 2018 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04811716 | Jul 2021 → Oct 2022 | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04888507 | Jul 2021 → May 2022 | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03946748 | May 2019 → Jun 2021 | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04209634 | Jan 2020 → Nov 2021 | protein-losing enteropathy | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT07154745 | Jun 2026 → Jan 2030 expected | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06541704 | Oct 2024 → Jul 2028 expected | dry age related macular degeneration | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05744921 | Mar 2023 → Oct 2028 expected | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05131204 | Oct 2022 → Jul 2023 | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05133531 | Aug 2022 → Oct 2026 expected | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05070858 | Dec 2021 → Jul 2025 overdue | generalized myasthenia gravis | Regeneron Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT04162470 | Dec 2019 → Apr 2022 | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 41 trial | ||||||
| Phase 4 | NCT07142343 | Mar 2026 → Feb 2030 expected | — | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase not stated3 trials | ||||||
| — | NCT06028594 | — | paroxysmal nocturnal hemoglobinuria | Regeneron Pharmaceuticals | No longer available | No outcome recorded |
| — | NCT06003881 | — | protein-losing enteropathy | Regeneron Pharmaceuticals | Approved for marketing | No outcome recorded |
| — | NCT05232110 | — | protein-losing enteropathy | Regeneron Pharmaceuticals | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-08-26 | Regeneron Pharmaceuticals | Results Regeneron Announces Positive Results from Phase 3 Trial in Generalized Myasthenia Gravis regeneron.com ↗ |
| 2024-12-07 | Regeneron Pharmaceuticals | Results Novel Combination of Pozelimab and Cemdisiran (Poze-Cemdi) Achieved Greater Control of Intravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria Compared to Ravulizumab regeneron.com ↗
Head-to-head exploratory cohort of a Phase 3 trial showed first-in-class poze-cemdi combination treatment helped patients achieve and maintain greater disease control, as measured by lactate dehydrogenase (LDH) levels, compared to standard-of-care ravulizumab |
| 2023-08-18 | Regeneron Pharmaceuticals | Regulatory Veopoz™ (pozelimab-bbfg) Receives FDA Approval as the First Treatment for Children and Adults with CHAPLE Disease regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has approved Veopoz™ (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. |
| 2023-02-21 | Regeneron Pharmaceuticals | Regulatory Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease Accepted for FDA Priority Review regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for pozelimab as a treatment for adults and children as young as 1 year of age with CHAPLE disease (also known as CD55 deficiency with Hyperactivation of complement, Angiopathic thrombosis and Protein Losing Enteropathy or CD55-deficient protein-losing enteropathy). |
| 2019-12-05 | Regeneron Pharmaceuticals | Results Regeneron Announces Positive Topline Phase 2 Data with Anti-C5 Antibody Pozelimab in Patients with a Rare Blood Disorder regeneron.com ↗
Pozelimab reduced the abnormal destruction of red blood cells, otherwise known as "hemolysis," with patients in the initial cohort achieving normal levels of a blood biomarker of elevated hemolysis called lactate dehydrogenase (LDH). |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-08-26 | Regeneron Pharmaceuticals | Regeneron Announces Positive Results from Phase 3 Trial in Generalized Myasthenia Gravis regeneron.com ↗ |
| 2024-12-07 | Regeneron Pharmaceuticals | Novel Combination of Pozelimab and Cemdisiran (Poze-Cemdi) Achieved Greater Control of Intravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria Compared to Ravulizumab regeneron.com ↗ |
| 2023-08-18 | Regeneron Pharmaceuticals | Veopoz™ (pozelimab-bbfg) Receives FDA Approval as the First Treatment for Children and Adults with CHAPLE Disease regeneron.com ↗ |
| 2023-02-21 | Regeneron Pharmaceuticals | Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease Accepted for FDA Priority Review regeneron.com ↗ |
| 2019-12-05 | Regeneron Pharmaceuticals | Regeneron Announces Positive Topline Phase 2 Data with Anti-C5 Antibody Pozelimab in Patients with a Rare Blood Disorder regeneron.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pozelimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07154745 ↗ |
| Known as | Pozelimab-bbfg | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298086 ↗ |
| Known as | REGN3918 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04162470 ↗ |
| Known as | Veopoz | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298086 ↗ |
| Action | Inhibit | “an antibody blocking complement component 5” PMID 38278170 ↗ Jan 2024 |
| Modality | Monoclonal antibody | “Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918” NCT03115996 ↗ |
| Route | Intravenous | “Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918” NCT03115996 ↗ |
| Route | Subcutaneous | “Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918” NCT03115996 ↗ |
| Target | C5 | “a C5 antibody (pozelimab)” PMID 42030965 ↗ Apr 2026 |