NDAORALTABLETPriority Review
Approved
Nov 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROMACTA (eltrombopag olamine) is an oral small-molecule thrombopoietin (TPO) receptor agonist approved by the FDA in 2008. It stimulates platelet production by binding to the TPO receptor on bone marrow progenitor cells. The drug is indicated for chronic immune thrombocytopenia (ITP) and other platelet disorders in patients with insufficient response to standard therapies.
$0.558BPart D
LOE ApproachingStable
1.6 years to LOEWith LOE approaching in 2028 and moderate competitive pressure (30/100), the commercial team is focused on maximizing remaining exclusivity period and preparing transition strategies.
Mechanism 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 (4)
Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State
Started Mar 2023
36 enrolled
Thrombocytopenia
Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State
Started Jan 2020
36 enrolled
Thrombocytopenia
Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia
Started May 2012
10 enrolled
Adult Acute Basophilic LeukemiaAdult Acute Eosinophilic LeukemiaAdult Acute Megakaryoblastic Leukemia (M7)+14 more
Promacta Pregnancy Registry
Started Mar 2010
1 enrolled
Purpura, Thrombocytopaenic, Idiopathic
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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.