Drugs / lipegfilgrastim
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Lonquex | — | 2013-07-25 | europa.eu ↗ |
Trials 4 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02306915 | Oct 2014 → Mar 2015 | — | Merckle GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01585649 | Jul 2012 → Jun 2014 | sarcoma | Merckle GmbH | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02488382 | Jul 2017 → Jul 2018 | plasma cell myeloma | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02044276 | Mar 2014 → Aug 2017 | aggressive B-cell non-Hodgkin lymphoma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-08-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives European Marketing Authorization for Lonquex® (XM22 lipegfilgrastim) tevapharm.com ↗ |
| 2013-06-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva’s Lonquex®(XM22 lipegfilgrastim) Recommended for Approval in the EU for the Reduction of Chemotherapy-Induced Neutropenia (CIN) tevapharm.com ↗ |
| 2011-06-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Successful Results of Phase III Study of Its Long-Acting G-CSF Product (Lipegfilgrastim) in Breast Cancer Patients tevapharm.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lipegfilgrastim | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02306915 ↗ |
| Known as | Lonquek | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02488382 ↗ |
| Known as | Lonquex | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594230 ↗ |
| Known as | XM-22 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594230 ↗ |
| Action | Activate | “Granulocyte colony stimulating factor receptor agonist” CHEMBL4594230 ↗ |
| Modality | Protein / enzyme biologic | “Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF)” NCT02488382 ↗ |
| Route | Subcutaneous | “subcutaneous (SC) injection of 6 mg lipegfilgrastim” NCT02044276 ↗ |
| Target | CSF3R | “Granulocyte colony stimulating factor receptor agonist” CHEMBL4594230 ↗ |