eflapegrastim
Trade name: Rolvedon
Approved
Sep 9, 2022
Eflapegrastim, sold under the brand name Rolvedon among others, is a long-acting G-CSF analog developed by Hanmi Pharmaceutical and licensed to Spectrum Pharmaceuticals. Eflapegrastim is a leukocyte growth factor. It is used to reduce the risk of febrile neutropenia in people with non-myeloid malignancies receiving myelosuppressive anti-cancer agents. — Wikipedia
Clinical trial activity
6 trials · 3 clinical orgs · 2 marketing orgs
Earliest trial started Dec 1, 2015 (NCT02643420)
Timeline
2010s
- Jan 1, 2015
Spectrum Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2017
Spectrum Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Spectrum Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Sep 9, 2022
Repligen Corporation — Earliest FDA Approval
- Sep 9, 2022
Spectrum Pharmaceuticals — Marketing Organization
- Sep 9, 2022
Repligen Corporation — NDA Secondary Org
- Sep 9, 2022
Repligen Corporation — NDA Organization
Indications
Approved for
Mechanism of action
Approval history
- approvedSep 9, 2022
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3833384 ↗
- WikipediaEflapegrastim ↗
Also known as
- eflapegrastim
- eflapegrastim
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05949333 | Phase 4 | Aug 31, 2023 | Chang Gung University, Hanmi Pharmaceutical |
| NCT04570423 | Phase 2 | Sep 30, 2020 | Spectrum Pharmaceuticals |
| NCT04187898 | Phase 1 | Dec 16, 2019 | Spectrum Pharmaceuticals |
| NCT03135951 | Phase 1 | May 1, 2017 | Spectrum Pharmaceuticals |
| NCT02953340 | Phase 3 | Feb 1, 2017 | Spectrum Pharmaceuticals |
| NCT02643420 | Phase 3 | Dec 1, 2015 | Spectrum Pharmaceuticals |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Spectrum Pharmaceuticals | For profit | 5 | 5 | 3 | 2015 |
| Chang Gung University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Hanmi Pharmaceutical | For profit | 1 | 0 | 1 | 2023 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Repligen Corporation | For profit | NDA2 | Sep 9, 2022 |
| Repligen Corporation | For profit | NDA | Sep 9, 2022 |
| Spectrum Pharmaceuticals | For profit | MKTG | Sep 9, 2022 |