Promacta

(Eltrombopag)

ApprovedSmall molecule

Eltrombopag is used to treat low platelet counts (the cells in blood that help with clotting) in patients with certain blood disorders like immune thrombocytopenia, so they're less likely to bleed.[2] Promacta is currently approved and in use across 18 indications[4].[1]

Promacta is one of 268 small molecule programs targeting Hemorrhage. It is currently in Approved.

Indications

136

Total Trials

Active Trials

267

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HemorrhageUnknown

Autoimmune Thrombocytopenic PurpuraUnknown

Connective Tissue DiseaseActive, not recruiting

Chronic Granulomatous Disease (CGD)Enrolling by invitation

Primary Immune Thrombocytopenia (ITP)Not yet recruiting

Primary Immune ThrombocytopeniaActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

ThrombocytopeniaUnknown status

Aplastic AnemiaCompleted

Fanconi AnemiaActive, not recruiting

HemorrhagePreclinical

Unknown

Autoimmune Thrombocytopenic PurpuraPreclinical

Unknown

Connective Tissue DiseasePreclinical

Active, not recruiting

Chronic Granulomatous Disease (CGD)Preclinical

Enrolling by invitation

Primary Immune Thrombocytopenia (ITP)Phase 2

Not yet recruiting

Primary Immune ThrombocytopeniaPhase 3

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

ThrombocytopeniaPhase 3

Unknown status

Aplastic AnemiaPhase 3

Completed

Fanconi AnemiaPhase 2

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Novantrone

Pfizer

Phase 3

34 3

Xospata

Astellas

Phase 3

24 4

Fludara

Sanofi

Phase 3

17 5

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

42 6

Vepesid

AAvyxa

Phase 3

52 7

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 9

Cerubidine

HHikma Pharmaceuticals LLC

Cellcept

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Not yet recruiting

Bone Marrow Failure

NCT06607367

N/ARecruiting

Efficacy and Safety

NCT06479291

Phase 2Active, not recruiting

Platelet Transfusion

NCT04797000

Post-ApprovalRecruiting

Children

NCT03844360

Q3 2027

Active, not recruiting

Myelodysplastic Neoplasm

NCT07825207

Q4 2027

N/ANot yet recruiting

Ripertamab

NCT06790888

Clinical

Trials by Indication[1]

Immune Thrombocytopenia14 trials

A Trial of Eltrombopag or Intravenous Immune Globulin Before Surgery for Immune Thrombocytopenia Patients

Completed·MMcMaster University·Phase 3·NCT01621204·74 enrolled

to Evaluate the Efficacy and Safety of Eltrombopag for Immune Thrombocytopenia With Chronic HBV Infection

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT03664518·48 enrolled

Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children

Completed·—·Phase 3·NCT03939637·122 enrolled

Show 11 more trials

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.

Completed· GSK logo

GSK·Phase 3·NCT01520909·92 enrolled

Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 4·NCT04518475·224 enrolled

Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto··NCT02298075·148 enrolled

Rituximab, Eltrombopag and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Unknown status·HHospital Universitario Dr. Jose E. Gonzalez·Phase 2·NCT02834286·15 enrolled

Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP)

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 4·NCT03771378·96 enrolled

Immune Thrombocytopenia Management in Adults

Unknown status·NNahda University·Phase 4·NCT05861297·467 enrolled

Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05369377·150 enrolled

Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.

Recruiting·RRenata PLC·Phase 1/2·NCT06531018·100 enrolled

A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital··NCT04214951·100 enrolled

Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)

Unknown status·PPeking University People's Hospital·Phase 1·NCT04518878·30 enrolled

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

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07687134·40 enrolled

Thrombocytopenia13 trials

Efficacy of Eltrombopag to Improve Thrombocytopenia of MYH9-related Disease

Completed·FFondazione IRCCS Policlinico San Matteo di Pavia·Phase 2·NCT01133860·12 enrolled

Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures

Terminated· GSK logo

GSK·Phase 3·NCT00678587·292 enrolled

Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT01791101·10 enrolled

Show 10 more trials

Perioperative Eltrombopag in Patients With Inherited Thrombocytopenia

Completed·UUniversity Hospital, Toulouse·Phase 2·NCT03638817·13 enrolled

A Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia

Unknown status·—·Phase 3·NCT02093325·83 enrolled

Eltrombopag for Inherited Thrombocytopenias

Completed·FFondazione IRCCS Policlinico San Matteo di Pavia·Phase 2·NCT02422394·24 enrolled

Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML

Unknown status·NNanfang Hospital, Southern Medical University·Phase 2/3·NCT03701217·220 enrolled

A Study of Eltrombopag in Patients With CMML and Thrombocytopenia

Completed·GGroupe Francophone des Myelodysplasies·Phase 1/2·NCT02323178·30 enrolled

Eltrombopag for Chemotherapy-induced Thrombocytopenia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT04600960·50 enrolled

Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

Terminated·—·Phase 1·NCT01491594·1 enrolled

MAP to Provide Access to Eltrombopag, for Treatment of Patients With Medically Significant Thrombocytopenia

Available· Novartis logo

Novartis··NCT04837703

Eltrombopag for Post Transplant Thrombocytopenia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01000051·64 enrolled

Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Withdrawn·UUniversity of Cincinnati·Phase 2·NCT01194167

Thrombocytopenic Purpura11 trials

Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT)

Completed· GSK logo

GSK·Phase 2·NCT00424177·66 enrolled

A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)

Terminated· Eisai logo

Eisai·Phase 3·NCT01433978·24 enrolled

Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura

Completed·HHumanity & Health Medical Group Limited·Phase 2·NCT03830749·53 enrolled

Show 8 more trials

Eltrombopag Induced Liver Dysfunction During Treatment of Immunethrombocytopenic Purpura

Recruiting·SSohag University·N/A·NCT07093606·100 enrolled

RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag

Completed· GSK logo

GSK·Phase 3·NCT00370331·197 enrolled

Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Completed· GSK logo

GSK·Phase 2·NCT00908037·82 enrolled

Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)

Completed·WWeill Medical College of Cornell University·Phase 2·NCT00902018·20 enrolled

Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim

Completed· GSK logo

GSK··NCT01439321·280 enrolled

Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag

Completed·IIngrid Pabinger, MD·Phase 4·NCT00888901·30 enrolled

Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Completed· GSK logo

GSK·Phase 3·NCT00828750·19 enrolled

A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Completed· Novartis logo

Novartis·Phase 3·NCT02201290·9 enrolled

Aplastic Anemia7 trials

Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects

Completed· Novartis logo

Novartis·Phase 2·NCT02404025·10 enrolled

Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA)

Completed·BB. Höchsmann·Phase 2/3·NCT02773225·93 enrolled

Eltrombopag for Moderate Aplastic Anemia

Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT01328587·34 enrolled

Show 4 more trials

Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic Anemia

Completed· Novartis logo

Novartis·Phase 2·NCT02998645·54 enrolled

Eltrombopag & Cyclosporine in Children With Sever Aplastic Anemia

Completed·—·Phase 4·NCT03243656·20 enrolled

A Pilot Study of the Thrombopoietin-Receptor Agonist Eltrombopag in Refractory Aplastic Anemia Patients

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00922883·43 enrolled

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

Completed· Novartis logo

Novartis·Phase 2·NCT03025698·51 enrolled

Severe Aplastic Anemia6 trials

Study Assessed the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects.

Completed· Novartis logo

Novartis·Phase 2·NCT03988608·20 enrolled

Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia

Completed· Novartis logo

Novartis·Phase 2·NCT04328727·36 enrolled

Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia

Completed·UUniversity of Utah·Phase 2·NCT01703169·13 enrolled

Show 3 more trials

A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia

Completed· Novartis logo

Novartis·Phase 2·NCT02148133·21 enrolled

Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)

Recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT04304820·80 enrolled

Extended Dosing With Eltrombopag for Severe Aplastic Anemia

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT01891994·40 enrolled

61 more indications

Myelodysplastic Syndrome5 trials

Safety Study of Eltrombopag Combined With Azacitidine to Treat Myelodysplastic Syndrome (MDS)

Completed·NNordic MDS Group·Phase 1·NCT01481220·12 enrolled

Eltrombopag With or Without Hypomethylating Agent After Hypomethylating Agent Failure For Patients With Myelodysplastic Syndrome (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01893372·29 enrolled

Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT01286038·37 enrolled

Show 2 more trials

Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (MDS)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02010645·6 enrolled

A Pilot Study of a Thrombopoietin-Receptor Agonist, Eltrombopag, in Patients With Low to Int-2 Risk Myelodysplastic Syndrome (MDS)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00961064·30 enrolled

Treatment3 trials

The Combination of ATRA and Eltrombopag as the Treatment of Steroid-resistant/Relapse ITP Based on MSC-C5b-9

Completed·PPeking University People's Hospital·Phase 3·NCT05438875·96 enrolled

A Rollover Study to Provide Continued Treatment With Eltrombopag

Completed· Novartis logo

Novartis·Phase 4·NCT01957176·22 enrolled

A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP

Completed· Novartis logo

Novartis·Phase 2·NCT03524612·105 enrolled

Liver Disease3 trials

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease

Completed· GSK logo

GSK·Phase 3·NCT00516321·687 enrolled

Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease

Completed· GSK logo

GSK·Phase 2·NCT00861601·38 enrolled

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

Completed· GSK logo

GSK·Phase 3·NCT00529568·759 enrolled

Myelodysplastic Syndromes2 trials

A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia

Completed· Novartis logo

Novartis·Phase 2·NCT01440374·162 enrolled

A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Terminated· Novartis logo

Novartis·Phase 3·NCT02158936·356 enrolled

Chronic Lymphocytic Leukemia2 trials

Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01168921·23 enrolled

Eltrombopag in Thrombocytopenic Chronic Lymphocytic Leukemia (CLL) Patients (CLL2S Study of GCLLSG)

Terminated·UUniversity of Ulm·Phase 1/2·NCT01397149·4 enrolled

Efficacy and Safety2 trials

A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP

Completed· Novartis logo

Novartis·Phase 2·NCT04346654·26 enrolled

The Efficacy and Safety of HCQ Plus TPO-RA in ANA Positive ITP

Recruiting·YYunfeng Cheng·N/A·NCT06479291·126 enrolled

Pediatric2 trials

Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect

Completed· GSK logo

GSK·Phase 1·NCT01072162·40 enrolled

The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP.

Completed·NNayera Hazaa Elsherif·N/A·NCT03412188·36 enrolled

Multiple Myeloma2 trials

Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma

Terminated·—·Phase 2·NCT01484314·1 enrolled

Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing ASCT

Completed·—·Phase 1·NCT01286675·19 enrolled

Fanconi Anemia2 trials

Eltrombopag for Treatment of Fanconi Anemia

Completed·JJulian Sevilla·Phase 2·NCT06045052·8 enrolled

Eltrombopag for Patients With Fanconi Anemia

Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT03206086·25 enrolled

Children2 trials

Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 3·NCT03413306·100 enrolled

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

Recruiting·WWei Zhao·Phase 4·NCT03844360·1,500 enrolled

Observational Study2 trials

WEUSKOP5410: Observational Study in ENABLE Clinical Trials

Completed· GSK logo

GSK··NCT01458080·1 enrolled

LENS - Long-term Eltrombopag Observational Study

Completed· GSK logo

GSK··NCT00643929·164 enrolled

Adult2 trials

Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP

Completed·QQilu Hospital of Shandong University·Phase 2·NCT04917679·102 enrolled

Eltrombopag Taste Testing in Healthy Adult Volunteers

Completed· GSK logo

GSK·Phase 1·NCT00487968·12 enrolled

Adult Subject2 trials

Drug Interaction Study Between Eltrombopag and Lopinavir/Ritonavir in Healthy Adult Subjects.

Completed· GSK logo

GSK·Phase 1·NCT00833378·40 enrolled

Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT01657552·56 enrolled

Randomized2 trials

A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients

Terminated·TTechnische Universität Dresden·Phase 2·NCT02446145·132 enrolled

A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 4·NCT05583838·157 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Eltrombopag at Escalated Doses

Completed·WWeill Medical College of Cornell University·Phase 2·NCT01880047·35 enrolled

A Safety and Efficacy Study of Eltrombopag in Subjects With AML

Completed· Novartis logo

Novartis·Phase 2·NCT01890746·148 enrolled

HSCT2 trials

The Use of Eltrombopag Post HSCT in BMFD

Completed·TThe First Affiliated Hospital of Soochow University·Phase 2/3·NCT05466201·118 enrolled

Eltrombopag vs. rhTPO to Increase Platelet Level After HSCT

Completed·SShenzhen Second People's Hospital·Phase 3·NCT03515096·98 enrolled

Pediatric Patients1 trial

Eltrombopag for Enhancing Platelet Engraftment in Pediatric Patients Undergoing Cord Blood Transplantation

Unknown status·Mmoshe yeshurun·Phase 2·NCT01940562·20 enrolled

Lactation1 trial

Milk-only Lactation Study for Patients on Eltrombopag

Withdrawn· GSK logo

GSK·Phase 4·NCT01055600

Renal Impairment1 trial

Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment

Completed· GSK logo

GSK·Phase 1·NCT00442871·29 enrolled

Hepatic Impairment1 trial

Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment

Completed· GSK logo

GSK·Phase 1·NCT00359463·33 enrolled

Chronic1 trial

Eltrombopag in Chronic ITP

Unknown status·—·Phase 4·NCT04102033·20 enrolled

TIA1 trial

Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag

Completed· GSK logo

GSK·Phase 1·NCT00688272·36 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Eltrombopag For Secondary Poor Graft Function Post Allogeneic Hematopoietic Stem Cell Transplantation

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT03437603·20 enrolled

Diamond-Blackfan anemia1 trial

Treatment of Refractory Diamond-Blackfan Anemia With Eltrombopag

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1/2·NCT04269889·15 enrolled

Phase II1 trial

Eltrombopag Phase III Study In Chinese Chronic ITP Patients

Completed· Novartis logo

Novartis·Phase 3·NCT01762761·155 enrolled

Toxicity1 trial

Eltrombopag Treatment in Patients With Prolonged BM Toxicity After CART

Unknown status·TTel-Aviv Sourasky Medical Center·Phase 2·NCT05286164·30 enrolled

Refractory1 trial

Association of FcγRIIIA Polymorphism and THPO Expression With Response to Eltrombopag in Refractory ITP Patients

Unknown status·NNational Institute of Blood and Marrow Transplant (NIBMT), Pakistan·Phase 3·NCT02877212·75 enrolled

Outcome1 trial

Outcomes in Bone Marrow Aplasia.

Not yet recruiting·—·Phase 3·NCT06493981·3 enrolled

Interaction1 trial

Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT02281370·39 enrolled

Ripertamab1 trial

Ripertamab Plus Eltrombopag vs. Eltrombopag in ITP Patients Post-Steroid Failure

Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·N/A·NCT06790888·78 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation

Terminated·UUniversity Hospital, Lille·Phase 2·NCT03948529·9 enrolled

Poor Graft Function1 trial

Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function

Terminated· Novartis logo

Novartis·Phase 2·NCT03718533·10 enrolled

Pregnancy1 trial

Promacta Pregnancy Registry

Completed· GSK logo

GSK··NCT01064336·1 enrolled

Prospective1 trial

The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT

Unknown status·SShandong Provincial Hospital··NCT03902041·160 enrolled

Platelet Transfusion1 trial

Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT04797000·36 enrolled

MPA1 trial

Indirect Comparison Between Eltrombopag & Romiplostim

Completed· GSK logo

GSK··NCT01236014·1 enrolled

Leukemia1 trial

Eltrombopag in Elderly Acute Myelogenous Leukemia (AML)

Terminated·—·Phase 1/2·NCT01113502·44 enrolled

Glucocorticoids1 trial

Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITP

Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 4·NCT07189910·150 enrolled

CMML1 trial

Eltrombopag as a Novel Therapeutic Approach for Low-risk MDS and CMML With TET2 Mutations

Recruiting·—·Phase 2·NCT06630221·25 enrolled

Bone Marrow Failure1 trial

REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2

Not yet recruiting·MMelbourne Health·Phase 1/2·NCT06607367·20 enrolled

Immunomodulation1 trial

Immunomodulation With Eltrombopag in ITP

Completed·UUniversity Children's Hospital Basel·Phase 2·NCT04812483·2 enrolled

Acute Myeloid Leukemia1 trial

Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy

Active, not recruiting·FFrench Innovative Leukemia Organisation·Phase 2·NCT03603795·110 enrolled

Clinical Trial1 trial

Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390

Completed· GSK logo

GSK·Phase 3·NCT00996216·27 enrolled

COVID-191 trial

Eltrombopag Plus rhTPO Versus Eltrombopag for ITP During the COVID-19 Pandemic (ELABORATE-19)

Unknown status·PPeking University People's Hospital·Phase 2·NCT04516837·120 enrolled

Connective Tissue Disease1 trial

Efficacy and Safety of Eltrombopag for Refractory Thrombocytopenia Associated With Connective Tissue Disease

Completed·TTongji Hospital··NCT06458803·52 enrolled

Fasting Conditions1 trial

A Pharmacokinetic Study of Eltrombopag 50 Milligram (mg) in Healthy Volunteers Under Fasting Conditions

Completed· GSK logo

GSK·Phase 1·NCT02254434·26 enrolled

Drug1 trial

Drug Use Investigation for REVOLADE (ITP)

Completed· Novartis logo

Novartis··NCT01416311·5,797 enrolled

Breast Cancer1 trial

Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)

Completed·UUniversity of California, San Francisco·Phase 1·NCT04542382·11 enrolled

Transplantation1 trial

Eltrombopag for Enhancing Platelet Engraftment in Adult Patients Undergoing Cord Blood Transplantation

Unknown status·RRabin Medical Center·Phase 2·NCT01757145·20 enrolled

Sarcoma1 trial

Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide

Completed· GSK logo

GSK·Phase 1·NCT00358540·18 enrolled

Immune1 trial

Eltrombopag in Second Line Adult Primary Immune Thrombosytopenia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT02402998·55 enrolled

Total Body Irradiation1 trial

Phase I Study of Eltrombopag for Promoting Thrombopoiesis After Total Body Irradiation

Completed·JJane Liesveld·Phase 1·NCT00903929·19 enrolled

Chronic Hepatitis1 trial

Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 2/3·NCT01821625·7 enrolled

Wiskott-Aldrich syndrome1 trial

Efficacy and Safety of Romiplostim Versus Eltrombopag in the Treatment of Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 2·NCT04371939·30 enrolled

Malignant Solid Tumors1 trial

Pilot Trial of Eltrombopag in Patients Undergoing Chemotherapy for Malignant Solid Tumors

Suspended·UUniversity of California, Davis·Phase 1·NCT04485416·10 enrolled

Myelodysplastic Neoplasm1 trial

Observational Study on Eltrombopag in Hypocellular Myelodysplastic Neoplasms

Active, not recruiting·FFondazione Italiana Sindromi Mielodisplastiche-ETS··NCT07825207·100 enrolled

Splenomegaly1 trial

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06345495·30 enrolled

Chronic Granulomatous Disease (CGD)1 trial

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

Enrolling by invitation·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT07113743·10 enrolled

Primary Immune Thrombocytopenia1 trial

A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05653219·152 enrolled

Primary Immune Thrombocytopenia (ITP)1 trial

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).

Not yet recruiting· Novartis logo

Novartis·Phase 2·NCT07660172·36 enrolled

Unspecified4 trials

Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies

Completed· Novartis logo

Novartis··NCT01715779·22 enrolled

Meta-analysis - Eltrombopag

Completed· GSK logo

GSK··NCT01235988·1 enrolled

Bioequivalence Study of Revolade® Eltrombopag 50 mg

Active, not recruiting·CCentro de Atencion e Investigacion Medica·Phase 4·NCT06834451·30 enrolled

Show 1 more trial

hATG+CsA vs hATG+CsA+Eltrombopag for SAA

Completed·EEuropean Society for Blood and Marrow Transplantation·Phase 3·NCT02099747·202 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 20, 2008

PROMACTA

NDA NDA022291

Mar 5, 2010

PROMACTA

NDA NDA022291

Dec 6, 2011

PROMACTA

NDA NDA022291

Nov 16, 2012

PROMACTA

NDA NDA022291

Feb 10, 2014

PROMACTA

NDA NDA022291

Apr 10, 2014

PROMACTA

NDA NDA022291

Jul 16, 2014

PROMACTA

NDA NDA022291

Aug 26, 2014

PROMACTA

NDA NDA022291

Apr 7, 2015

PROMACTA

NDA NDA022291

Jun 11, 2015

PROMACTA

NDA NDA022291

Aug 24, 2015

PROMACTA KIT

NDA NDA207027

Oct 12, 2016

PROMACTA

NDA NDA022291

Mar 9, 2017

PROMACTA KIT

NDA NDA207027

Mar 9, 2017

PROMACTA

NDA NDA022291

Jul 5, 2017

PROMACTA KIT

NDA NDA207027

Jul 5, 2017

PROMACTA

NDA NDA022291

Oct 4, 2017

PROMACTA

NDA NDA022291

May 25, 2018

PROMACTA KIT

NDA NDA207027

Jul 24, 2018

PROMACTA KIT

NDA NDA207027

Jul 24, 2018

PROMACTA

NDA NDA022291

Sep 27, 2018

PROMACTA KIT

NDA NDA207027

Nov 16, 2018

PROMACTA

NDA NDA022291

Apr 24, 2019

PROMACTA KIT

NDA NDA207027

Apr 28, 2020

PROMACTA

NDA NDA022291

Apr 29, 2020

PROMACTA

NDA NDA022291

Apr 29, 2020

PROMACTA KIT

NDA NDA207027

Oct 8, 2020

PROMACTA KIT

NDA NDA207027

Feb 3, 2021

PROMACTA KIT

NDA NDA207027

Feb 3, 2021

PROMACTA

NDA NDA022291

Mar 31, 2022

PROMACTA

NDA NDA022291

Mar 31, 2022

PROMACTA KIT

NDA NDA207027

Nov 15, 2022

PROMACTA

NDA NDA022291

Mar 9, 2023

PROMACTA KIT

NDA NDA207027

Mar 9, 2023

PROMACTA

NDA NDA022291

Jul 6, 2023

PROMACTA

NDA NDA022291

Dec 27, 2024

PROMACTA

NDA NDA022291

Jun 6, 2025

PROMACTA KIT

NDA NDA207027

Jun 6, 2025

PROMACTA

NDA NDA022291

Sources

References

[1]
ClinicalTrials.gov — 136 trial records for Eltrombopag. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Promacta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Eltrombopag compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Eltrombopag. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA207027). U.S. Food & Drug Administration.
[6]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thrombopoietin Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GSK

Promacta

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Trials by Indication[1]

Immune Thrombocytopenia14 trials

Thrombocytopenia13 trials

Thrombocytopenic Purpura11 trials

Aplastic Anemia7 trials

Severe Aplastic Anemia6 trials

Myelodysplastic Syndrome5 trials

Treatment3 trials

Liver Disease3 trials

Myelodysplastic Syndromes2 trials

Chronic Lymphocytic Leukemia2 trials

Efficacy and Safety2 trials

Pediatric2 trials

Multiple Myeloma2 trials

Fanconi Anemia2 trials

Children2 trials

Observational Study2 trials

Adult2 trials

Adult Subject2 trials

Randomized2 trials

Safety and Efficacy2 trials

HSCT2 trials

Pediatric Patients1 trial

Lactation1 trial

Renal Impairment1 trial

Hepatic Impairment1 trial

Chronic1 trial

TIA1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Diamond-Blackfan anemia1 trial

Phase II1 trial

Toxicity1 trial

Refractory1 trial

Outcome1 trial

Interaction1 trial

Ripertamab1 trial

Allogeneic Hematopoietic Cell Transplant1 trial

Poor Graft Function1 trial

Pregnancy1 trial

Prospective1 trial

Platelet Transfusion1 trial

MPA1 trial

Leukemia1 trial

Glucocorticoids1 trial

CMML1 trial

Bone Marrow Failure1 trial

Immunomodulation1 trial

Acute Myeloid Leukemia1 trial

Clinical Trial1 trial

COVID-191 trial

Connective Tissue Disease1 trial

Fasting Conditions1 trial

Drug1 trial

Breast Cancer1 trial

Transplantation1 trial

Sarcoma1 trial

Immune1 trial

Total Body Irradiation1 trial

Chronic Hepatitis1 trial

Wiskott-Aldrich syndrome1 trial

Malignant Solid Tumors1 trial

Myelodysplastic Neoplasm1 trial

Splenomegaly1 trial

Chronic Granulomatous Disease (CGD)1 trial

Primary Immune Thrombocytopenia1 trial

Primary Immune Thrombocytopenia (ITP)1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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