Drugs / Eflapegrastim
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04187898 | Mar 2020 → Jul 2024 | breast cancer, neutropenia | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03135951 | May 2017 → Feb 2018 | breast cancer | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01037543 | Nov 2009 → Feb 2011 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT00998283 | Oct 2009 → Sep 2010 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04570423 | May 2021 → Oct 2027 expected | cancer, lymphoma | Spectrum Pharmaceuticals, Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT01724866 | Mar 2013 → Aug 2014 | neutropenia | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02953340 | May 2017 → Jun 2018 | breast cancer, neutropenia | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT02643420 | Jan 2016 → Jan 2018 | breast cancer, neutropenia | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05949333 | Nov 2023 → Jan 2025 | breast neoplasm | Eunseong Medical Foundation Good GANG-AN HOSPITAL | Unknown | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eflapegrastim | “A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of...” PMID 34993933 ↗ Jan 2022 |
| Known as | Eflapegrastim-xnst | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833384 ↗ |
| Known as | HM10460A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00998283 ↗ |
| Known as | HNK460 | “Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects” NCT00998283 ↗ |
| Known as | Rolontis | “Eflapegrastim (Rolontis®) is a novel long-acting pegylated recombinant human granulocyte colony-stimulating factor (G-CSF).” PMID 34993933 ↗ Jan 2022 |
| Known as | Rolvedon | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833384 ↗ |
| Known as | SPI-2012 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01724866 ↗ |
| Known as | SPL-2012 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833384 ↗ |
| Action | Activate | “Granulocyte colony stimulating factor receptor agonist” CHEMBL3833384 ↗ |
| Modality | Protein / enzyme biologic | “Eflapegrastim (Rolontis®) is a novel long-acting pegylated recombinant human granulocyte colony-stimulating factor (G-CSF).” PMID 34993933 ↗ Jan 2022 |
| Route | Subcutaneous | “Subcutaneously administrate at 0 hour on Day 1” NCT00998283 ↗ |
| Target | CSF3R | “Granulocyte colony stimulating factor receptor agonist” CHEMBL3833384 ↗ |