NDAORALTABLETPriority Review
Approved
Nov 2008
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
44
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROMACTA (eltrombopag olamine) is an oral small-molecule thrombopoietin (TPO) receptor agonist approved by FDA in November 2008 and currently marketed by Novartis. It works by binding to the transmembrane domain of the human TPO-receptor (cMpl) and triggering signaling cascades that promote megakaryocyte proliferation and differentiation, thereby increasing platelet production. PROMACTA is indicated for treating thrombocytopenia across multiple conditions including chronic immune thrombocytopenia (ITP), hepatitis C-associated thrombocytopenia (to enable interferon therapy), and severe aplastic anemia (in combination with standard immunosuppressive therapy). It represents a foundational treatment option in the TPO-agonist class and serves as a first-line agent for platelet production disorders.
$0.6BPart D
1.7 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (44)
Revolade Tablets Specified Drug-use Survey
Started Jul 2024
10 enrolled
Aplastic Anemia
Eltrombopag for Peripheral Blood Stem Cell Harvest
Started Aug 2023
46 enrolled
LymphomaPeripheral Blood Stem Cell Transplantation
A Study of the Safety and Effectiveness of Eltrombopag in Combination With Immunosuppressive Therapy (IST) in Korean Pediatric Patients With Treatment Naïve Severe Aplastic Anemia
Started Jun 2023
13 enrolled
Aplastic Anemia
Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State
Started Mar 2023
36 enrolled
Thrombocytopenia
Immunomodulation With Eltrombopag in ITP
Started Sep 2022
2 enrolled
Primary Immune Thrombocytopenia (ITP)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.