Romiplostim

Generic Name: Romiplostim

Brand Names: Nplate

Drug Type: Biotech

CAS Number: 267639-76-9

Unique Ingredient Identifier: GN5XU2DXKV

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

Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia

Phase 2

Not yet recruiting

Conditions: Cancer Treatment-induced Thrombocytopenia (CTIT)

Interventions: Drug: Romiplostim N01

First Posted Date: 2025-03-27

Last Posted Date: 2025-03-28

Lead Sponsor: Anhui Provincial Hospital

Target Recruit Count: 97

Registration Number: NCT06898983

Locations: 🇨🇳
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, China

FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

Phase 3

Not yet recruiting

Conditions: CTIT: Cancer Therapy Induced Thrombocytopenia

Interventions: Drug: Romiplostim N01
Drug: Recombinant Human Interleukin-11 (rhIL-11)

First Posted Date: 2025-01-06

Last Posted Date: 2025-01-06

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Target Recruit Count: 88

Registration Number: NCT06759636

Locations: 🇨🇳
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China

Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT

Phase 2

Recruiting

Conditions: Platelet Recovery After Umbilical Cord Blood Transplantation

Interventions: Drug: Romiplostim N01

First Posted Date: 2024-11-18

Last Posted Date: 2024-11-18

Lead Sponsor: Anhui Provincial Hospital

Target Recruit Count: 34

Registration Number: NCT06693791

Locations: 🇨🇳
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, China

A Study of Romiplostim for the Treatment of Refractory Transfusion-dependent NSAA

Phase 4

Not yet recruiting

Conditions: Aplastic Anemia

Interventions: Drug: Romiplostim

First Posted Date: 2024-08-02

Last Posted Date: 2024-08-02

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 40

Registration Number: NCT06535685

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

Ropustin for Refractory Aplastic Anaemia After Radiotherapy - a Single-centre, Prospective, Open-label, Single-arm Study

Phase 4

Not yet recruiting

Conditions: Aplastic Anemia

Interventions: Drug: Romiplostim

First Posted Date: 2024-07-24

Last Posted Date: 2024-07-24

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 40

Registration Number: NCT06516484

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia

Phase 3

Active, not recruiting

Conditions: Safety Issues
Immunogenicity
Drug Effect

Interventions: Drug: Nplate
Drug: GP404141

First Posted Date: 2024-07-11

Last Posted Date: 2024-07-11

Lead Sponsor: Geropharm

Target Recruit Count: 160

Registration Number: NCT06497036

Locations: 🇷🇺
Kaluga Regional Clinical Hospital, Kaluga, Russian Federation
🇷🇺
Samara State Medical University" of the Ministry of Health of the Russian Federation, Samara, Russian Federation
🇷🇺
City Clinical Hospital S.P. Botkin of the Moscow City Health Department, Moscow, Russian Federation

and more 3 locations