CLINICAL TRIALS PROFILE FOR ELTROMBOPAG OLAMINE

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.

Clinical Trial Conditions for eltrombopag olamine

Condition Name

Condition Name for eltrombopag olamine
Intervention	Trials
Purpura, Thrombocytopaenic, Idiopathic	5
Thrombocytopenia	3
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)	2

Condition MeSH

Condition MeSH for eltrombopag olamine
Intervention	Trials
Thrombocytopenia	8
Purpura, Thrombocytopenic, Idiopathic	8
Purpura, Thrombocytopenic	6

Clinical Trial Locations for eltrombopag olamine

Trials by Country

Trials by Country for eltrombopag olamine
Location	Trials
United States	90
Germany	34
Italy	31
China	17
Canada	16

Trials by US State

Trials by US State for eltrombopag olamine
Location	Trials
New York	8
Texas	6
Georgia	6
Virginia	5
Missouri	4

Clinical Trial Progress for eltrombopag olamine

Clinical Trial Phase

Clinical Trial Phase for eltrombopag olamine
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	2
Phase 3	3

Clinical Trial Status

Clinical Trial Status for eltrombopag olamine
Clinical Trial Phase	Trials
Completed	11
Active, not recruiting	3
Terminated	2

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

Sponsor Type

Sponsor Type for eltrombopag olamine
Sponsor	Trials
Other	25
Industry	17
NIH	5

Clinical Trials Update, Market Analysis and Projection for Eltrombopag Olamine

Last updated: February 21, 2026

What is the current status of clinical trials for Eltrombopag Olamine?

Eltrombopag Olamine is an oral thrombopoietin receptor agonist developed for various thrombocytopenic conditions. It is currently in several phases of clinical testing:

• Approved Indications: Approved in multiple jurisdictions for chronic immune thrombocytopenia (ITP). First approved in the U.S. in 2018 by the FDA.

• Ongoing Trials: As of Q1 2023, multiple trials are active or completed, including:

  • Phase 3: Trials for aplastic anemia and hepatitis C-associated thrombocytopenia. For example, NCT03675746 investigates efficacy in refractory aplastic anemia.

  • Phase 2: Studies for cirrhosis-related thrombocytopenia, such as NCT04522044.

• Recent Results: Positive results published in 2022 show efficacy in increasing platelet counts in thrombocytopenic patients with a manageable safety profile.

How does clinical trial activity compare globally?

Phase	Number of Trials	Key Regions	Recent Trends (2021-2023)
Phase 2	4	U.S., Europe	Increased focus on non-ITP indications.
Phase 3	2	U.S., China	Expansion into additional thrombocytopenic conditions.
Other	3	Multiple regions	Observational studies, biosimilar development.

Sources: ClinicalTrials.gov, 2023.

What are the market dynamics shaping the drug's prospects?

Current Market Size

• The global thrombopoietin receptor agonist market was valued at approximately USD 2.3 billion in 2022.
• Eltrombopag holds an estimated 55% market share in approved indications in the U.S.

Competitive Landscape

• Competing drugs include romiplostim and avatrombopag.
• Eltrombopag's oral formulation offers patient convenience over injectable alternatives like romiplostim.

Market Drivers

• Rising prevalence of ITP and aplastic anemia globally.
• Increasing approval for additional indications, expanding addressable patient populations.
• Management of thrombocytopenia in chemotherapy and hepatitis C remains a significant segment.

Regulatory and Patent Factors

• Patent expiry is anticipated post-2030 in major markets, prompting potential biosimilar entry.
• Recent FDA approval pathways for expanded indications facilitate faster access.

What are the projections for Eltrombopag Olamine over the next five years?

Year	Estimated Market Share	Projected Market Size (USD billion)	Key Drivers
2023	55%	1.27	Launch of new indications in China and Europe; ongoing clinical success
2024	60%	1.44	Expanded labeling in ITP, aplastic anemia; increased awareness
2025	65%	1.70	Entry into pediatric indications; new combination therapies
2026	70%	2.00	Patent protection maintained; biosimilars delayed
2027	75%	2.35	Broader global reimbursement; inclusion in chronic disease guidelines

Market Opportunities and Risks

• Opportunities: Growth in underserved populations, combination therapy approvals, potential use in oncology supportive care.
• Risks: Patent expirations, biosimilar competition, adverse safety reports, regulatory delays.

Sources: EvaluatePharma, 2023; IQVIA, 2023.

Key Takeaways

• Eltrombopag Olamine is actively progressing through clinical development for additional thrombocytopenic indications beyond ITP.
• The drug commands a majority share in its current approved segments, with opportunities in expanding global markets.
• Market size is expected to grow to USD 2.35 billion by 2027, driven by increased indication approvals and geographic expansion.
• Competition from injectable alternatives and biosimilars remains a significant factor influencing future profitability.

FAQs

1. What are the main approved uses of Eltrombopag Olamine?
Approved primarily for chronic immune thrombocytopenia in adults. Also approved for severe aplastic anemia in some markets.

2. Are there any notable safety concerns?
Common adverse events include headache, nausea, and increased liver enzymes. Rare cases involve hepatotoxicity and thromboembolic events.

3. What are the prospects for new indications?
Clinical trials target aplastic anemia, hepatitis C, and cirrhosis-related thrombocytopenia. Approval could significantly expand the patient base.

4. Who are the main competitors?
Romiplostim (Injectable TPO receptor agonist), avatrombopag (Oral).

5. How will patent expiry affect the market?
Patent expiration post-2030 may lead to biosimilar entry, impacting pricing and market share.

References

[1] ClinicalTrials.gov. (2023). Eltrombopag trials.
[2] EvaluatePharma. (2023). Thrombopoietin receptor agonists market report.
[3] IQVIA. (2023). Global oncology and hematology market analysis.