You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR ELTROMBOPAG OLAMINE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Eltrombopag Olamine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00351468 ↗ EXTEND (Eltrombopag Extended Dosing Study) Completed Novartis Phase 3 2006-06-01 An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.
NCT00351468 ↗ EXTEND (Eltrombopag Extended Dosing Study) Completed Novartis Pharmaceuticals Phase 3 2006-06-01 An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.
NCT00370331 ↗ RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag Completed GlaxoSmithKline Phase 3 2006-11-01 The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP. Subjects will be randomized 2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects will receive study medication for 6 months, during which the dose of study medication may be adjusted based upon individual platelet counts. In addition, subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care. After discontinuation of study medication, subjects will complete follow-up visits at weeks 1, 2, 4 and months 3 and 6.
NCT00424177 ↗ Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT) Completed GlaxoSmithKline Phase 2 2007-03-01 This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the pharmacodynamics and durability of eltrombopag response as measured by the peripheral platelet counts. For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov
NCT00643929 ↗ LENS - Long-term Eltrombopag Observational Study Completed GlaxoSmithKline 2007-02-01 A long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag. The study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.
NCT00903422 ↗ Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS) Completed GlaxoSmithKline Phase 1 2009-05-14 This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.
NCT01098487 ↗ A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Completed GlaxoSmithKline Phase 4 2010-05-01 A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Eltrombopag Olamine

Condition Name

Condition Name for Eltrombopag Olamine
Intervention Trials
Purpura, Thrombocytopaenic, Idiopathic 5
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 2
Thrombocytopaenia 2
Adult Acute Myeloid Leukemia With Del(5q) 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Eltrombopag Olamine
Intervention Trials
Purpura, Thrombocytopenic, Idiopathic 7
Purpura, Thrombocytopenic 6
Purpura 6
Thrombocytopenia 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Eltrombopag Olamine

Trials by Country

Trials by Country for Eltrombopag Olamine
Location Trials
United States 90
Germany 34
Italy 31
Canada 16
China 14
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Eltrombopag Olamine
Location Trials
New York 8
Georgia 6
Texas 6
Virginia 5
Florida 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Eltrombopag Olamine

Clinical Trial Phase

Clinical Trial Phase for Eltrombopag Olamine
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2/Phase 3 1
[disabled in preview] 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Eltrombopag Olamine
Clinical Trial Phase Trials
Completed 9
Active, not recruiting 3
Terminated 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Eltrombopag Olamine

Sponsor Name

Sponsor Name for Eltrombopag Olamine
Sponsor Trials
GlaxoSmithKline 7
National Cancer Institute (NCI) 5
Novartis Pharmaceuticals 4
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Eltrombopag Olamine
Sponsor Trials
Other 24
Industry 15
NIH 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Eltrombopag Olamine: Clinical Trials, Market Analysis, and Projections

Introduction to Eltrombopag Olamine

Eltrombopag olamine, a thrombopoietin receptor agonist, is a crucial medication in the treatment of various thrombocytopenic conditions. It works by stimulating the production of platelets in the bone marrow, making it an essential drug for patients with low platelet counts.

Clinical Trials and Current Uses

Approved Uses

Eltrombopag olamine is approved for the treatment of thrombocytopenia in several conditions, including chronic immune thrombocytopenia (ITP) in adults and children aged 1 year or older, and in patients with chronic hepatitis C undergoing interferon-based therapy. It is also indicated for chemotherapy-induced thrombocytopenia in solid tumors and severe aplastic anemia[1][3][4].

Ongoing Clinical Trials

The drug is currently under clinical development for several other conditions:

  • Fanconi Anemia: Eltrombopag olamine is in Phase II clinical trials for the treatment of Fanconi anemia, a rare genetic disorder that affects the body's ability to produce blood cells[3].
  • Severe Aplastic Anemia: It is being evaluated for its efficacy in treating severe aplastic anemia, a condition where the bone marrow fails to produce new blood cells[3][4].
  • Acute Myelocytic Leukemia and Myelodysplastic Syndrome: The drug is also under investigation for its potential in treating acute myelocytic leukemia and myelodysplastic syndrome[3].
  • Pediatric Trials: Clinical trials such as the PETIT and PETIT2 studies have demonstrated the efficacy and safety of eltrombopag in children with chronic ITP[4].

Market Analysis

Global Market Overview

The global eltrombopag olamine market is projected to experience significant growth over the next decade. Here are some key points from the market analysis:

  • Growth Rate: The market is expected to grow at a compound annual growth rate (CAGR) of a notable percentage from 2024 to 2034, reaching a substantial value by the end of the forecast period[2][5].
  • Regional Dominance: North America currently dominates the market, accounting for more than 46% of the revenue, due to the high prevalence of target diseases, established healthcare infrastructure, and favorable reimbursement policies[2].

Regional Market Forecasts

  • North America: This region is expected to continue its dominance due to the factors mentioned above. The presence of major pharmaceutical companies and a well-developed healthcare system further supports this growth[2].
  • Europe: The European market benefits from the rising incidence of cancer and other thrombocytopenic conditions. Favorable reimbursement policies and an aging population also drive demand for eltrombopag olamine in this region[2].
  • Asia Pacific: This region is anticipated to be the fastest-growing segment, driven by increasing healthcare expenditure, growing awareness of thrombocytopenic conditions, and improving healthcare infrastructure[2].

Market Drivers and Challenges

  • Drivers: The market is driven by the increasing prevalence of thrombocytopenic conditions, advancements in healthcare infrastructure, and favorable reimbursement policies. Research and development endeavors also play a crucial role in expanding therapeutic applications[2][5].
  • Challenges: Despite the positive outlook, the market faces challenges such as high development costs, stringent regulatory requirements, and potential side effects associated with the drug[5].

Key Players in the Market

Several major pharmaceutical companies are involved in the development and distribution of eltrombopag olamine:

  • GlaxoSmithKline: Known for its brand name Promacta, GlaxoSmithKline is a leading player in the market.
  • Novartis Pharmaceuticals: Novartis is also a significant player, particularly with its ongoing clinical trials for new indications.
  • Other Companies: Selleck Chemicals, Adooq Bioscience, Taiclone, CSNpharm, and MedKoo are among the other companies operating in this market[2].

Market Projections

Revenue and Growth

The eltrombopag olamine market is expected to achieve substantial revenue growth during the forecast period from 2024 to 2034. The market size is projected to increase significantly, driven by the increasing demand for thrombopoietin receptor agonists and the expansion of therapeutic applications[2][5].

Future Outlook

The future outlook for the eltrombopag olamine market is promising, with continued innovation in drug development and an increasing focus on rare and underserved conditions. As more clinical trials reach completion and new indications are approved, the market is likely to see further growth.

"Eltrombopag olamine is under clinical development by Novartis and currently in Phase II for Fanconi Anemia. According to GlobalData, Phase II drugs for Fanconi Anemia do not have sufficient historical data to build an indication benchmark PTSR for Phase II."[3]

Side Effects and Safety Profile

Eltrombopag olamine has a generally favorable safety profile, but like any medication, it can cause side effects. Common adverse effects include headache, nausea, and hepatobiliary laboratory abnormalities. Long-term safety data in children are limited, but studies in adults have not shown a significant increase in thrombosis, marrow fibrosis, or cataract formation[4].

Key Takeaways

  • Clinical Trials: Eltrombopag olamine is being studied for various new indications, including Fanconi anemia, severe aplastic anemia, and acute myelocytic leukemia.
  • Market Growth: The global market is expected to grow significantly, driven by increasing demand and favorable market conditions.
  • Regional Dominance: North America leads the market, followed by Europe and the Asia Pacific region.
  • Key Players: Major pharmaceutical companies like GlaxoSmithKline and Novartis are key players in the market.
  • Safety Profile: The drug has a generally favorable safety profile but can cause side effects such as headache and nausea.

FAQs

What is eltrombopag olamine used for?

Eltrombopag olamine is used to treat thrombocytopenia in conditions such as chronic immune thrombocytopenia (ITP), chronic hepatitis C, chemotherapy-induced thrombocytopenia in solid tumors, and severe aplastic anemia[1][3][4].

What are the common side effects of eltrombopag olamine?

Common side effects include headache, nausea, and hepatobiliary laboratory abnormalities. Long-term safety data in children are limited, but studies in adults have not shown significant adverse effects[4].

Which companies are major players in the eltrombopag olamine market?

Major players include GlaxoSmithKline, Novartis Pharmaceuticals, Selleck Chemicals, Adooq Bioscience, Taiclone, CSNpharm, and MedKoo[2].

What is the current market size and growth projection for eltrombopag olamine?

The market is expected to grow at a significant CAGR from 2024 to 2034, reaching a substantial value by the end of the forecast period. North America dominates the market, with Europe and the Asia Pacific region also showing significant growth[2][5].

Is eltrombopag olamine approved for use in children?

Yes, eltrombopag olamine is approved for the treatment of chronic ITP in children aged 1 year or older. Clinical trials such as PETIT and PETIT2 have demonstrated its efficacy and safety in pediatric patients[4].

What are the ongoing clinical trials for eltrombopag olamine?

Eltrombopag olamine is currently in clinical trials for Fanconi anemia, severe aplastic anemia, acute myelocytic leukemia, and myelodysplastic syndrome[3].

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.