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Drug

Eltrombopag

Approved · EMA
Emerging researchLate-stage developmentRising momentum

Also known as Alvaiz, Promacta, Eltrombopagum.

RxNorm711942ChEMBLCHEMBL461101UNIIS56D65XJ9G
4
Research papers
20
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Eltrombopag Combined With Telitacicept Versus Eltrombopag Monotherapy for the Treatment of Immune Thrombocytopenia Refractory or Relapsed to Corticosteroid Therapy: A Randomized Exploratory, Controlled, Open-label, Phase II Clinical Study

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

A Phase 2, Open-label, Single-arm Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary Immune Thrombocytopenia Who Had an Insufficient Response to or Relapsed After First-line Corticosteroid Treatment (VAYHIT-P).

Clinical trial2026-06-25Results expected Q2 2033 · ClinicalTrials.gov

Part B- Phase I/II, Non-Randomized, Single Site Study, Open-label Study of G1XCGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease

Clinical trial2026-06-22Results expected Q3 2028 · ClinicalTrials.gov

A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients

Clinical trial2026-04-29Results expected Q1 2029 · ClinicalTrials.gov

A Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Moderate Aplastic Anemia Patients

Clinical trial2026-04-23Results posted · ClinicalTrials.gov

High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly

Clinical trial2026-03-11Results expected Q1 2027 · ClinicalTrials.gov

Drug Safety Update: Eltrombopag (Revolade): reports of interference with bilirubin and creatinine test results

Regulatory2018-07-17MHRA

Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial.

Research2015-07-28Lancet (London, England)

Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study.

Research2015-07-28The Lancet. Haematology

Eltrombopag restores trilineage hematopoiesis in refractory severe aplastic anemia that can be sustained on discontinuation of drug.

Research2013-12-17Blood

Eltrombopag and improved hematopoiesis in refractory aplastic anemia.

Research2012-07-01The New England journal of medicine

Approval: Revolade (EMA)

Regulatory2010-03-11EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Eltrombopag
Aliases & brands
AlvaizPromactaEltrombopagum
RxNorm CUI
711942
ChEMBL ID
CHEMBL461101
UNII
S56D65XJ9G
Regulatory jurisdictions
mhraema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2010-03-11
Latest approval
2010-03-11
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2010-03-11Approval
Approval: Revolade (EMA)
Indication: Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)… Show full indication

Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1). Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2018-07-17Safety communicationSafety
Drug Safety Update: Eltrombopag (Revolade): reports of interference with bilirubin and creatinine test results
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

122 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
122
registered trials across all phases
LATEST COMPLETION 2026
20
Active studies
15
Recruiting
41
Late-stage (III+)
69
Completed
33
Discontinued
PHASE DISTRIBUTIONn = 122
Early Phase 11Phase 117Phase 1 / 27Phase 256Phase 2 / 34Phase 321Phase 412Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients

RecruitingPH IVInstitute of Hematology & Blood Diseases Hospital, Chinan=2242030

Efficacy and Safety of Glucocorticoids Combined With Recombinant Human Thrombopoietin (rhTPO) Sequential Eltrombopag Olamine for Severe Primary Immune Thrombocytopenia (ITP) in Adults

Not yet recruitingPH IVUnion Hospital, Tongji Medical College, Huazhong University of Science and Technologyn=1502027

Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease

RecruitingPH IVKey trialWei Zhaon=1,5002026

Bioequivalence Study of Revolade® Eltrombopag 50 mg Tablets - Novartis Vs Myelone ® Eltrombopag 50 mg Tablets - Colompack / Immediate Release Tablets in Healthy Subjects Under Fasting Condition

Active, not recruitingPH IVCentro de Atencion e Investigacion Medican=302025

Comparing the Efficacy and Safety of Optimized rhTPO Treatment Versus Eltrombopag Treatment in Previously Treated Primary Immune Thrombocytopenia Patients: A Multicenter Randomized Open-label Trial

CompletedPH IVInstitute of Hematology & Blood Diseases Hospital, Chinan=1572024

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Moderate Aplastic Anemia Patients

CompletedPH IINational Heart, Lung, and Blood Institute (NHLBI)n=342026

A Multicenter Clinical Study of a TPO Receptor Agonist (Eltrombopag) in the Acceleration of Engraftment Post Hematopoietic Stem Cell Transplantation of Bone Marrow Failure Diseases

CompletedPH II/IIIThe First Affiliated Hospital of Soochow Universityn=1182025

A Phase III Study of Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia in Children

CompletedPH IIIBaylor College of Medicinen=1222025

Efficacy and Safety of Thrombopoetin-Receptor Agonist Eltrombopag in in Combination With Ciclosporin A in Moderate Aplastic Anemia (EMAA): Prospective Randomized Multicenter Study

CompletedPH II/IIIB. Höchsmannn=932025

A Phase II, Open-label, Non-controlled, Intra-patient Dose-escalation Study to Characterize the Pharmacokinetics After Oral Administration of Eltrombopag in Pediatric Patients With Refractory, Relapsed or Treatment Naive Severe Aplastic Anemia or Recurrent Aplastic Anemia

CompletedPH IINovartis Pharmaceuticalsn=512025

A Non-randomized, Open Label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin (r-ATG) and Cyclosporine A (CsA) in East-Asian Patients With Treatment Naive Severe Aplastic Anemia (REACTS)

CompletedPH IINovartis Pharmaceuticalsn=362024

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20122015
Journals, researchers & institutions
Top journals
  • Blood1
  • Lancet (London, England)1
  • The Lancet. Haematology1
  • The New England journal of medicine1
Leading researchers
  • Bailey CK2
  • Bakshi KK2
  • Bussel JB2
  • Calvo KR2
  • Chagin KD2
  • Chan GW2
  • Desmond R2
  • Dumitriu B2
Leading institutions
free-text, unnormalised
  • and Blood Institute2
  • Collegeville2
  • Royal Manchester Children's Hospital2
  • Weill Cornell Medical College2
  • Baylor College of Medicine1
  • Children's Hospital of Pittsburgh of UPMC1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.