In short
Eltrombopag olamine is a thrombopoietin receptor agonist, a medicine that helps the body make more platelets. It is authorised for use in conditions including severe aplastic anemia and thrombocytopenia related to chronic hepatitis C. The two trials on this page are Phase 1 bioequivalence studies, each with 72 healthy participants, completed to compare a test 75 mg film-coated tablet with a reference product.
Key points
- Eltrombopag olamine is a thrombopoietin receptor agonist used to treat low platelet counts.
- The two registered trials are Phase 1 bioequivalence studies in healthy volunteers.
- Each trial enrolled 72 participants and has a Completed status.
- Both studies tested a 75 mg film-coated tablet taken by mouth.
- One trial was conducted under fasting conditions and the other under fed conditions.
- The main goal was to compare drug levels in the blood between a test and a reference product.
What is eltrombopag olamine?
Eltrombopag olamine is a medicine that belongs to a class of drugs called thrombopoietin receptor agonists. It is a chemically synthesised substance. The medicine is authorised for use in the United States, where it was first approved in 2008. It is also known simply as eltrombopag. The product used in the registered trials is a film-coated tablet supplied by Bluepharma Indústria Farmacêutica S.A.
How does eltrombopag olamine work?
Eltrombopag olamine works by stimulating the thrombopoietin receptor. This receptor is found on the surface of cells in the bone marrow that produce platelets. When the receptor is activated, it signals the bone marrow to make more platelets, which can help raise a low platelet count. The medicine is classified under the ATC code B02BX05, a group of other systemic hemostatics.
Which conditions is eltrombopag olamine used for?
According to the prescribing information, eltrombopag olamine is authorised for the following uses:
- Severe aplastic anemia — a serious condition where the bone marrow fails to make enough blood cells. Eltrombopag is used in combination with standard immunosuppressive therapy as a first-line treatment for adults and children aged 2 years and older.
- Thrombocytopenia in chronic hepatitis C — a low platelet count that prevents patients from starting or continuing interferon-based therapy for hepatitis C. Eltrombopag helps raise platelets so that treatment can proceed.
- Thrombocytopenia — a condition of low blood platelets, as listed in the trial records for the bioequivalence studies.
How is eltrombopag olamine given?
Eltrombopag olamine is given by mouth as a film-coated tablet. The registered trials used a 75 mg strength. The NHS dm+d browser also lists a 50 mg tablet as a valid prescribable product in the United Kingdom. The prescribing information notes that eltrombopag tablets are for oral use.
What do the clinical trials show?
The two registered trials are both Phase 1 bioequivalence studies. They were designed to show that a test 75 mg film-coated tablet of eltrombopag produces the same drug levels in the body as a reference product. Each study enrolled 72 healthy participants and both are now completed.
The first trial was conducted under fasting conditions, meaning participants took the tablet on an empty stomach. The second trial was conducted under fed conditions, meaning participants took the tablet after a meal.
The main measurement in both trials was pharmacokinetics — how the drug is absorbed, distributed, and eliminated by the body. The studies measured the maximum observed plasma concentration (Cmax), the time to reach that maximum (Tmax), and the area under the plasma concentration versus time curve (AUC), which reflects total drug exposure over 72 hours.
What side effects are known?
The prescribing information includes boxed warnings about liver risks. In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation, a serious worsening of liver function. Eltrombopag may also increase the risk of severe and potentially life-threatening hepatotoxicity, or liver damage. Liver function should be monitored during treatment.