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Label indication PROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. FDA label
Also known as eltrombopag olamine (SB-497115-GR)
eltrombopag olamine · 1 trial · 1 indication
All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.
| Arm | Type | Description |
|---|---|---|
| Eltrombopag | EXPERIMENTAL | Open-label eltrombopag |
| Name | Type | Description |
|---|---|---|
| eltrombopag olamine (SB-497115-GR) | DRUG | Eltrombopag with starting dose of 50mg daily, max dose of 75mg daily and min dose of 25mg daily or less frequently. Modifications were given to maintain platelet count in range of 50 to 200 Gi/L. |
Inclusion Criteria: * Subject has signed and dated a written informed consent. * Adults (≥18 years) diagnosed with ITP according to the American Society for Hematology/British Committee for Standards in Haematology (ASH/BCSH) guidelines \[George, 1996; BCSH, 2003\]. In addition, a peripheral blood ...
Eltrombopag olamine is a small molecule developed by Novartis AG (ticker NVS) for immune thrombocytopenic purpura, also called idiopathic thrombocytopenic purpura. It is an orally administered agent studied in hematology, and it has been evaluated in a Phase 3 clinical program. It is also known by the research code SB-497115-GR.
Eltrombopag olamine is used for purpura, thrombocytopaenic, idiopathic, commonly called immune thrombocytopenic purpura, a hematologic condition marked by low platelet counts. Its clinical development in this indication includes the Phase 3 EXTEND study, which enrolled 302 adult patients aged 18 years and older across 31 countries.
Eltrombopag olamine targets MPL, the thrombopoietin receptor, and acts as an agonist at that receptor. By activating MPL signaling, the drug is designed to stimulate platelet production. This mechanism underlies its study in immune thrombocytopenic purpura, where platelet counts are reduced.
Eltrombopag olamine is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor associated with the clinical development program for the drug in immune thrombocytopenic purpura, including the Phase 3 EXTEND trial.
Eltrombopag olamine is in Phase 3 development for immune thrombocytopenic purpura. The program includes one completed Phase 3 trial, and no trials are currently listed as active. The drug is investigational in this dataset and is not described as approved.
Eltrombopag olamine has been studied in NCT00351468, the EXTEND (Eltrombopag Extended Dosing Study), a completed Phase 3 trial in immune thrombocytopenic purpura. It enrolled 302 adults aged 18 years and older, was open to all sexes, and did not include healthy volunteers. It was an uncontrolled study conducted across 31 countries.
Yes, SB-497115-GR is a research code for eltrombopag olamine. The two names refer to the same small molecule developed by Novartis AG for immune thrombocytopenic purpura, so searches for either name point to the same Phase 3 hematology asset.