PROMACTA KIT (eltrombopag olamine)
PROMACTA KIT is indicated for the treatment of Thrombocytopenia; Immune Thrombocytopenia; Chronic Hepatitis C; Severe Aplastic Anemia.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-08-24
- Patent Cliff
- 2026
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION
PROMACTA KIT Approval History
What PROMACTA KIT Treats
4 indicationsPROMACTA KIT is approved for 4 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thrombocytopenia
- Immune Thrombocytopenia
- Chronic Hepatitis C
- Severe Aplastic Anemia
PROMACTA KIT Boxed Warning
RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions ( 5.1 )] . Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended [see Warnings and Precautions ( 5.2 )] . WARNING: RISK FOR HEPAT...
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions ( 5.1 )] . Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended [see Warnings and Precautions ( 5.2 )] . WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning. In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation. ( 5.1 ) Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. ( 5.2 )
PROMACTA KIT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PROMACTA KIT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PROMACTA KIT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PROMACTA KIT
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 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 |
| 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) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 KIT FDA Label Details
Indications & Usage
FDA Label (PDF)PROMACTA KIT is indicated for the treatment of Thrombocytopenia; Immune Thrombocytopenia; Chronic Hepatitis C; Severe Aplastic Anemia.
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions ( 5.1 )] . Eltrombopag...
PROMACTA KIT Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for PROMACTA KIT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 20 active patents
Trial Analysis
- • 81 total trials
- • Stage: Declining
Competitive Landscape
- • 9 similar drugs
- • Same target/indication analysis
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