Overview
Romiplostim is a thrombopoiesis stimulating dimer Fc-peptide fusion protein (peptibody) to increase platelet production through activation of the thrombopoietin receptor. The peptibody molecule has two identical single-chain subunits, each one is made up of 269 amino acid residues. Each subunit consists of an IgG1 Fc carrier domain that is covalently attached to a polypeptide sequence that contains two binding domains to interact with thrombopoietin receptor c-Mpl. Each domain consists of 14 amino acids. Interestingly, romiplostim's amino acid sequence is not similar to that of endogenous thrombopoietin. Romiplostim is produced by recombinant DNA technology in Escherichia coli. FDA approved on August 22, 2008.
Background
Romiplostim is a thrombopoiesis stimulating dimer Fc-peptide fusion protein (peptibody) to increase platelet production through activation of the thrombopoietin receptor. The peptibody molecule has two identical single-chain subunits, each one is made up of 269 amino acid residues. Each subunit consists of an IgG1 Fc carrier domain that is covalently attached to a polypeptide sequence that contains two binding domains to interact with thrombopoietin receptor c-Mpl. Each domain consists of 14 amino acids. Interestingly, romiplostim's amino acid sequence is not similar to that of endogenous thrombopoietin. Romiplostim is produced by recombinant DNA technology in Escherichia coli. FDA approved on August 22, 2008.
Indication
Treatment of chronic immune thrombocytopenic purpura.
Associated Conditions
- Chronic immune thrombocytopenia
- Refractory immune thrombocytopenia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/02 | Not Applicable | Recruiting | |||
2025/06/29 | Not Applicable | Not yet recruiting | |||
2025/06/04 | N/A | ENROLLING_BY_INVITATION | Haikou Affiliated Hospital of Central South University Xiangya School of Medicine | ||
2025/06/03 | Phase 2 | Not yet recruiting | Anjali Sharathkumar | ||
2025/03/27 | Phase 2 | Not yet recruiting | Anhui Provincial Hospital | ||
2025/01/06 | Phase 3 | Not yet recruiting | |||
2024/11/18 | Phase 2 | Recruiting | Anhui Provincial Hospital | ||
2024/08/02 | Phase 4 | Not yet recruiting | |||
2024/07/24 | Phase 4 | Not yet recruiting | |||
2024/07/11 | Phase 3 | Active, not recruiting | Geropharm |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/4/2009 | ||
Authorised | 2/4/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ROMIPLATE POWDER FOR SOLUTION FOR INJECTION 250 μg/vial | SIN14688P | INJECTION, POWDER, FOR SOLUTION | 250 μg/vial (deliverable amount) | 12/3/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Romiplostim N01 for Injection | 国药准字S20240013 | 生物制品 | 注射剂 | 4/2/2024 | |
| Romiplostim N01 for Injection | 国药准字S20240014 | 生物制品 | 注射剂 | 4/2/2024 | |
| Romiplostim for Injection | 国药准字SJ20220001 | 生物制品 | 注射剂 | 1/7/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ROMIPLATE POWDER FOR SOLUTION FOR INJECTION 250MCG | N/A | N/A | N/A | 6/30/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NPLATE romiplostim (rbe) 375 microgram powder for injection vial | 147187 | Medicine | A | 8/8/2008 | |
| NPLATE romiplostim (rbe) 625 microgram powder for injection vial | 147188 | Medicine | A | 8/8/2008 | |
| NPLATE romiplostim (rbe) 230 microgram powder for injection vial | 283890 | Medicine | A | 10/23/2017 |