Data updated: May 26, 2026
PROMACTA (eltrombopag olamine)
Trial Activity: Declining 1 active trials
Infectious Disease
Approved 2008-11-20
Development Insights
GlaxoSmithKline conducting 3 trials (30%)
40 indications explored (Broad Platform)
→ thrombocytopenia (2 trials)
→ lymphoma (1 trials)
→ peripheral blood stem cell transplantation (1 trials)
6
Indications
--
Phase 3 Trials
5
Priority Reviews
17
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-11-20
- Patent Cliff
- 2028
- Revenue
- $226M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
PROMACTA Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
130 FDA actions from 2008 to 2025 · 5 indication expansions
What PROMACTA Treats
6 FDA approvalsOriginally approved for its first indication in 2008 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals)- • Approved indication (Nov 2008) PriorityLabel Letter
- • Approved indication (Feb 2011)Label Letter
- • Approved indication (Nov 2012) PriorityLabel Letter
- • Approved indication (Aug 2014) PriorityLabel Letter
- • Approved indication (Jun 2015) PriorityLabel Letter
- • Approved indication (Nov 2018) PriorityLabel Letter
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05961410 EPBSCH | 202301091MIFC | Ph 2 | recruiting | Eltrombopag for Peripheral Blood Stem Cell Harvest |
| NCT01927731 results posted | 2012-0920 NCI-2013-02348, 2012-0920 | Ph 2 | completed | Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant |
| NCT01428635 results posted | 2011-0319 NCI-2011-03336, 2011-0319 | Ph 2, Ph 3 | completed | Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy |
| NCT01772420 results posted | 2012-407 NCI-2013-01219, P30CA013330 | Ph 2 | completed | Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia |
| NCT01550185 | I 206111 NCI-2012-00215 | Ph 1 | terminated | Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia |
| NCT00909363 WAS results posted | 0801009600 | Ph 2 | terminated | Thrombocytopenia and Bleeding in Wiskott-Aldrich Syndrome (WAS) Patients |
| NCT01610180 | VI-Plt-01 | Ph 2 | completed | Eltrombopag for the Treatment of Immune ThrombocytoPenia (ITP) Secondary to Chronic Lymphoproliferative Disorders (LPDs) |
| NCT00903422 | 112509 | Ph 1 | completed | Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS) |
| NCT01147809 results posted | 112765 | Ph 2 | completed | Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag |
| NCT01098487 results posted | 112940 | Ph 4 | completed | A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROMACTA FDA Label Details
View full patent landscape →
12 OB patents · 2 families ·
186 international docs across 41 countries
PROMACTA Patents & Exclusivity
Latest Patent: Feb 2028
Patents (12 active)
US8828430*PED
Expires Feb 1, 2028
US8052993*PED
Expires Feb 1, 2028
US8052994*PED
Expires Feb 1, 2028
US8062665*PED
Expires Feb 1, 2028
US8071129*PED
Expires Feb 1, 2028
US8052994
Expires Aug 1, 2027
US8071129
Expires Aug 1, 2027
US8052993
Expires Aug 1, 2027
US8062665
Expires Aug 1, 2027
US8828430
Expires Aug 1, 2027
US7547719*PED
Expires Jan 13, 2026
US7547719
Expires Jul 13, 2025
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for PROMACTA
Revenue Insights
- • Q4-2025: $226M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 395 active patents
Trial Analysis
- • 10 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment