Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for the treatment of idiopathic thrombocytopenic purpura, a condition characterized by low platelet counts. It is a small molecule being developed by Novartis AG for this hematologic indication. The drug is currently in Phase 3 clinical development.
Eltrombopag olamine targets the thrombopoietin receptor, which plays a key role in regulating platelet production. By stimulating this receptor, the drug aims to increase platelet counts in patients with idiopathic thrombocytopenic purpura. This mechanism is central to its therapeutic effect in this hematologic condition.
Eltrombopag olamine is developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. Novartis is responsible for the clinical development and potential commercialization of this drug for idiopathic thrombocytopenic purpura.
Eltrombopag olamine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of idiopathic thrombocytopenic purpura, with one completed Phase 3 trial involving 302 participants.
Eltrombopag olamine has been studied in the EXTEND trial (NCT00351468), a Phase 3 study that has been completed. This trial enrolled 302 participants with idiopathic thrombocytopenic purpura across multiple countries, including the United States, Australia, Canada, and various European and Asian nations. The trial was uncontrolled and not randomized.
Eltrombopag olamine is a salt form of eltrombopag, and the two names refer to the same active pharmaceutical ingredient. The olamine salt is used to improve the drug's solubility and stability. In clinical trials and medical literature, the drug is often referred to simply as eltrombopag.