Overview
Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Indication
For the treatment of anemia (from renal transplants or certain HIV treatment)
Associated Conditions
- Anemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/17 | Phase 4 | Active, not recruiting | |||
2025/06/04 | Not Applicable | Not yet recruiting | |||
2024/06/20 | Phase 3 | Recruiting | |||
2023/05/18 | Phase 4 | Completed | Yi Fang | ||
2023/03/15 | Phase 3 | Recruiting | |||
2022/04/22 | Phase 2 | Recruiting | |||
2022/03/03 | Phase 2 | Completed | |||
2021/07/13 | Phase 4 | Completed | Rufaida Mazahir | ||
2021/03/15 | Phase 1 | Active, not recruiting | |||
2020/06/16 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/8/2001 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NESP INJECTION PLASTIC SYRINGE 60 μg/0.5 ml | SIN14743P | INJECTION, SOLUTION, CONCENTRATE | 60 μg | 3/2/2015 | |
| NESP INJECTION PLASTIC SYRINGE 180 μg/0.5 ml | SIN14745P | INJECTION, SOLUTION, CONCENTRATE | 180 μg | 3/2/2015 | |
| NESP INJECTION PLASTIC SYRINGE 120 μg/0.5 ml | SIN14744P | INJECTION, SOLUTION, CONCENTRATE | 120 μg | 3/2/2015 | |
| NESP INJECTION PLASTIC SYRINGE 30 μg/0.5 ml | SIN14741P | INJECTION, SOLUTION, CONCENTRATE | 30 μg | 3/2/2015 | |
| NESP INJECTION PLASTIC SYRINGE 10 μg/0.5 ml | SIN14739P | INJECTION, SOLUTION, CONCENTRATE | 10 μg | 3/2/2015 | |
| NESP INJECTION PLASTIC SYRINGE 20 μg/0.5 ml | SIN14740P | INJECTION, SOLUTION, CONCENTRATE | 20 μg | 3/2/2015 | |
| NESP INJECTION PLASTIC SYRINGE 40 μg/0.5 ml | SIN14742P | INJECTION, SOLUTION, CONCENTRATE | 40 μg | 3/2/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Darbepoetin alfa Injection | S20200014 | 生物制品 | 注射剂 | 6/17/2020 | |
| Darbepoetin alfa Injection | S20200013 | 生物制品 | 注射剂 | 6/17/2020 | |
| Darbepoetin alfa Injection | S20200011 | 生物制品 | 注射剂 | 6/17/2020 | |
| Darbepoetin alfa Injection | S20200012 | 生物制品 | 注射剂 | 6/17/2020 | |
| Darbepoetin alfa Injection | S20200015 | 生物制品 | 注射剂 | 6/17/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NESP INJECTION PLASTIC SYRINGE 40MCG/0.5ML | N/A | N/A | N/A | 8/25/2014 | |
| NESP INJECTION PLASTIC SYRINGE 180MCG/0.5ML | N/A | N/A | N/A | 8/25/2014 | |
| NESP INJECTION PLASTIC SYRINGE 20MCG/0.5ML | N/A | N/A | N/A | 8/25/2014 | |
| NESP INJECTION PLASTIC SYRINGE 120MCG/0.5ML | N/A | N/A | N/A | 8/25/2014 |
TGA Drug Approvals
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