Drugs / ZALTENIBART
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05889299 | Dec 2022 → Nov 2025 | paroxysmal nocturnal hemoglobinuria | Omeros Corporation | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT06209736 | Mar 2024 → Jan 2026 overdue | complement 3 glomerulopathy, immune-complex glomerulonephritis | Omeros Corporation | Recruiting | No outcome recorded |
| Phase 2 | NCT06298955 | Feb 2024 → Dec 2026 expected | paroxysmal nocturnal hemoglobinuria | Omeros Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05972967 | Mar 2023 → Oct 2024 | paroxysmal nocturnal hemoglobinuria | Omeros Corporation | Completed | Met primary |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2024-12-10 | Omeros Corporation | Results Omeros Corporation Announces Presentation of Positive Zaltenibart Data at ASH Annual Meeting omeros.com ↗
In PNH patients experiencing substantial extravascular hemolysis while receiving ravulizumab, zaltenibart monotherapy resulted in sustained clinically meaningful improvements in both hemoglobin and absolute reticulocyte count and prevented both intravascular and extravascular hemolysis. |
| 2024-10-24 | Omeros Corporation | Regulatory FDA Grants Rare Pediatric Disease Designation to Omeros’ MASP-3 Inhibitor Zaltenibart for Treatment of C3 Glomerulopathy omeros.com ↗
Omeros Corporation today announced that zaltenibart (OMS906) has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the treatment of complement 3 glomerulopathy (C3G), an ultra-rare, progressive renal disorder primarily afflicting children and young adults. |
| 2023-11-02 | Omeros Corporation | Results Omeros Corporation Announces Upcoming Presentations at ASH Annual Meeting omeros.com ↗
OMS906, a Novel Alternative Pathway MASP-3 Inhibitor, Normalizes Hemoglobin Levels and Increases Clone Size in Treatment-Naïve PNH Patients |
| 2023-06-12 | Omeros Corporation | Results Omeros Corporation Announces Availability on Its Website of Materials Accompanying Presentations of OMS906 Data at the 2023 European Hematology Association Congress omeros.com ↗
This poster presentation describes findings from a single-ascending dose study evaluating OMS906 safety, pharmacokinetics and pharmacodynamics in healthy subjects. |
| 2023-05-09 | Omeros Corporation | Results Omeros Corporation Reports First Quarter 2023 Financial Results omeros.com ↗
In April 2023 , we announced positive results from a pre-specified interim analysis of our ongoing Phase 1b clinical trial of OMS906 in treatment-naïve adults with paroxysmal nocturnal hemoglobinuria (“PNH”), and updated interim results are provided later in this release. |
| 2023-04-25 | Omeros Corporation | Results Omeros Corporation Reports Interim Data with Alternative Pathway Inhibitor OMS906 as Monotherapy in Patients with Paroxysmal Nocturnal Hemoglobinuria omeros.com ↗ |
| 2022-07-29 | Omeros Corporation | Regulatory FDA Grants Orphan Drug Designation to Omeros’ MASP-3 Inhibitor OMS906 for Treatment of Paroxysmal Nocturnal Hemoglobinuria omeros.com ↗
Omeros Corporation today announced that OMS906 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). |
| 2021-08-09 | Omeros Corporation | Results Omeros Corporation Reports Second Quarter 2021 Financial Results omeros.com ↗
Omeros announced preliminary results from the Phase 1 clinical trial of OMS906, the company’s MASP-3 inhibitor, which showed that (i) OMS906 was well tolerated at all doses tes |
| 2021-06-09 | Omeros Corporation | Results Omeros Announces Preliminary Results from Phase 1 Clinical Trial of OMS906 omeros.com ↗
Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced preliminary results from the Phase 1 clinical trial of its MASP-3 inhibitor OMS906. |
| 2020-10-16 | Omeros Corporation | Results Omeros’ OMS906 Data Presented at Complement-based Drug Development Summit omeros.com ↗
The presentation included data demonstrating that a single dose of OMS906 in an animal study demonstrated a decrease of mature CFD and an increase and accumulation in pro-CFD levels that remained detectable for more than three weeks. |
| 2020-08-31 | Omeros Corporation | Regulatory Omeros’ Investigational New Drug Application for OMS906 Cleared by FDA omeros.com ↗
Omeros Corporation today announced that its Investigational New Drug Application (IND) to begin clinical trials with OMS906 has been cleared by the U.S. Food and Drug Administration (FDA). |
| 2020-08-10 | Omeros Corporation | Regulatory Omeros Corporation Reports Second Quarter 2020 Financial Results omeros.com ↗
Omeros submitted a clinical trial application to European regulators and an investigational new drug application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for OMS906, the company’s MASP-3 inhibitor. |
| 2016-11-10 | Omeros Corporation | Results Single Dose of Omeros’ Lead MASP-3 Inhibitor OMS906 Shows Multi-Week Blockade of the Alternative Pathway omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced pharmacokinetic and pharmacodynamic data from the evaluation of OMS906 in non-human primates. |
| 2016-08-10 | Omeros Corporation | Results Omeros’ Lead MASP-3 Inhibitor OMS906 Demonstrates Efficacy in Paroxysmal Nocturnal Hemoglobinuria Model omeros.com ↗
In a well-established animal model associated with paroxysmal nocturnal hemoglobinuria (PNH), OMS906 significantly improved the survival of red blood cells when compared to control-treated animals and to animals treated with a complement component 5 (C5) inhibitor. |
| 2016-08-04 | Omeros Corporation | Results Omeros’ Lead MASP-3 Inhibitor OMS906 Demonstrates Blockade of the Alternative Pathway of Complement System omeros.com ↗
OMS906 significantly reduced both incidence and severity of disease in a well-established animal model of arthritis mediated by the APC. |
All press releases naming this drug 20 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZALTENIBART | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068191 ↗ |
| Known as | OMS906 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06298955 ↗ |
| Modality | Monoclonal antibody | — CHEMBL6068191 ↗ |
| Route | Intravenous | “3 mg/kg and 5 mg/kg IV given to PNH patients at 8-week intervals” NCT05972967 ↗ |