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Promacta (ELTROMBOPAG)
Promacta works by binding to the thrombopoietin receptor, stimulating platelet production in the bone marrow.
Promacta (eltrombopag) is a thrombopoietin receptor agonist, a small molecule that targets the thrombopoietin receptor to stimulate platelet production. It was originally developed by Novartis and is used to treat chronic idiopathic thrombocytopenic purpura (ITP). Promacta was FDA-approved in 2008 and is currently owned by Novartis. The drug has a half-life of 21 to 32 hours and is available as a generic medication. Key safety considerations include the risk of liver toxicity and the potential for interactions with other medications.
At a glance
| Generic name | ELTROMBOPAG |
|---|---|
| Sponsor | Novartis |
| Drug class | Thrombopoietin Receptor Agonist |
| Target | Thrombopoietin receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2008 |
| Annual revenue | 569 |
Mechanism of action
Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor and initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells.
Approved indications
- Persistent or Chronic ITP
- Thrombocytopenia in Chronic Hepatitis C
- Severe Aplastic Anemia (First-Line)
- Severe Aplastic Anemia (Second-Line)
Boxed warnings
- 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 )
Common side effects
- Nausea
- Diarrhea
- Upper respiratory tract infection
- Vomiting
- Urinary tract infection
- Increased ALT
- Myalgia
- Oropharyngeal pain
- Increased AST
- Pharyngitis
- Back pain
- Influenza
Drug interactions
- Polyvalent Cations (iron, calcium, aluminum, magnesium, selenium, zinc)
- OATP1B1 Substrates (atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38, valsartan)
- BCRP Substrates (imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan)
- HIV Protease Inhibitors (lopinavir/ritonavir)
- Hepatitis C Virus Protease Inhibitors (boceprevir, telaprevir)
- Peginterferon Alfa-2a/b
Key clinical trials
- RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag (PHASE3)
- Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease (PHASE3)
- A Pilot Study of the Thrombopoietin-Receptor Agonist Eltrombopag in Refractory Aplastic Anemia Patients (PHASE2)
- SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP) (PHASE2)
- Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. (PHASE3)
- EXTEND (Eltrombopag Extended Dosing Study) (PHASE3)
- Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease (PHASE3)
- Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Promacta CI brief — competitive landscape report
- Promacta updates RSS · CI watch RSS
- Novartis portfolio CI