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Efbemalenograstim alpha

Trade name: Ryzneuta

Recombinant proteinapproved

Approved

Nov 16, 2023

Clinical trial activity

11 trials · 14 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
10
Phase 3
3
Phase 4
0

Earliest trial started Jun 1, 2012 (NCT01648322)

Timeline

2010s

  1. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2016

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Nov 16, 2023

    EVIVE Biotechnology — Earliest FDA Approval

  2. Nov 16, 2023

    EVIVE Biotechnology — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 16, 2023

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • f-627

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07187908Phase 2Jan 1, 2025Henan Medical University, Sichuan University
NCT06649448N/AOct 10, 2024Shandong University
NCT06251947Phase 2Apr 15, 2024Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd, Shandong University
NCT06134765Phase 2Nov 30, 2023Zhejiang University
NCT04174599Phase 3Apr 12, 2018Fudan University, Generon (Shanghai) Corporation Ltd.
NCT03252431Phase 3Feb 28, 2018Generon (Shanghai) Corporation Ltd.
NCT02872103Phase 3Aug 1, 2016Generon (Shanghai) Corporation Ltd.
NCT02521441Phase 2May 1, 2014Fudan University, Generon (Shanghai) Corporation Ltd., Guangzhou Medical University, Huazhong University of Science and Technology, Jiao Tong University, Nantong University, Qingdao University, Southern Medical University
NCT02522234Phase 1/Phase 2 (Phase 2)Mar 1, 2014Fudan University, Generon (Shanghai) Corporation Ltd., Sun Yat-Sen University
NCT02527746Phase 1/Phase 2 (Phase 2)Dec 1, 2012Fudan University, Generon (Shanghai) Corporation Ltd.
NCT01648322Phase 2Jun 1, 2012Generon (Shanghai) Corporation Ltd.
Showing 11 of 11 trials
Page 1 / 1

Organizations

Research & Development (14)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Generon (Shanghai) Corporation Ltd.For profit7722012
Fudan UniversityAcademic/Hospital4022012
Shandong UniversityAcademic/Hospital2222024
Guangzhou Medical UniversityAcademic/Hospital1012014
Henan Medical UniversityAcademic/Hospital1112025
Huazhong University of Science and TechnologyAcademic/Hospital1012014
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,LtdFor profit1012024
Jiao Tong UniversityAcademic/Hospital1012014
Nantong UniversityAcademic/Hospital1012014
Qingdao UniversityAcademic/Hospital1012014
Sichuan UniversityAcademic/Hospital1012025
Southern Medical UniversityAcademic/Hospital1012014
Sun Yat-Sen UniversityAcademic/Hospital1012014
Zhejiang UniversityAcademic/Hospital1112023
14 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
EVIVE BiotechnologyFor profitNDANov 16, 2023