Drugs / F-627

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Ryzneuta 2024-03-21 europa.eu

Trials 11 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02527746 Dec 2012 → Dec 2013 breast cancer, neutropenia EVIVE Biotechnology Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02522234 Feb 2014 → Aug 2015 neutropenia EVIVE Biotechnology Completed No outcome recorded
Phase 25 trials
Phase 2 NCT07187908 Jan 2025 → Oct 2026 expected chemotherapy-induced toxicity Henan Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT06251947 Apr 2024 → Jun 2026 overdue cervical cancer, ovarian cancer Shandong University Recruiting No outcome recorded
Phase 2 NCT06134765 Nov 2023 → Oct 2024 colorectal cancer, malignant pancreatic neoplasm Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
Phase 2 NCT02521441 Jul 2014 → Sep 2015 neutropenia EVIVE Biotechnology Completed No outcome recorded
Phase 2 NCT01648322 Jun 2012 → Dec 2014 breast cancer, neutropenia EVIVE Biotechnology Completed No outcome recorded
Phase 33 trials
Phase 3 NCT03252431 Apr 2018 → Sep 2019 female breast carcinoma, neutropenia EVIVE Biotechnology Completed No outcome recorded
Phase 3 NCT04174599 Apr 2018 → Jan 2019 breast cancer, neutropenia EVIVE Biotechnology Completed No outcome recorded
Phase 3 NCT02872103 Aug 2016 → Dec 2017 breast cancer, neutropenia EVIVE Biotechnology Completed No outcome recorded
Phase not applicable1 trial
NCT06649448 Oct 2024 → Dec 2025 overdue neutropenia Shandong Cancer Hospital and Institute Not yet recruiting No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

FieldValueCited text
Known as F-627 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02872103
6

NCT04174599

NCT02522234

NCT02527746

NCT03252431

NCT02521441

NCT01648322

Known as Bemalenograstim alfa ClinicalTrials.gov intervention name — accepted as the source's own label NCT06134765
Known as efbemalenograstim alfa “F-627 (efbemalenograstim alfa) is a novel long acting granulocyte colony-stimulating factor (G-CSF) that contains two human G-CSF fused to a human immunoglobulin G2 (hIgG2) -Fc...” PMID 39272058 Sep 2024
3

NCT07187908

NCT06649448

NCT06251947

Known as Ryzneuta “This studyevaluated the efficacy and safety of F-627, also known as efbemalenograstim alfa (Ryzneuta®) in reducing neutropenia compared with filgrastim (GRAN®).” PMID 39272058 Sep 2024
Modality Protein / enzyme biologic “rh G-CSF Fc Fusion Protein” NCT02522234
Route Subcutaneous “by subcutaneous injection” NCT02522234