Promacta Kit

(Eltrombopag Olamine)

ApprovedSmall molecule

Novartis

Promacta Kit is one of 200 small molecule programs targeting Thrombocytopenic Purpura. It is currently in Approved.

Indications

Total Trials

Active Trials

199

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Thrombocytopenic PurpuraActive, not recruiting

AnemiaActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

Myeloid LeukemiaActive, not recruiting

Thrombocytopenic PurpuraApproved

Active, not recruiting

AnemiaPhase 2

Active, not recruiting

Myelodysplastic SyndromePhase 1

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

Immune ThrombocytopeniaPhase 2

Active, not recruiting

Myeloid LeukemiaPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Pfizer

Phase 3

32 2

Fludara

Sanofi

Phase 3

15 3

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

31 4

Promacta Kit

Novartis

Approved

2 5

Novantrone

EMD Serono

Phase 3

19 6

Bicnu

MMelissa K Accordino

Phase 3

1 7

Active Comparator

Moderna

Phase 3

1 8

Lenograstim

Sanofi

Phase 3

1 9

Experimental

Biogen

Phase 3

1 10

Valspodar

EEastern Cooperative Oncology Group

Phase 3

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

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia2 trials

Eltrombopag Olamine in Improving Platelet Recovery in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

Unknown status·—·Phase 2·NCT02071901·31 enrolled

Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia

Terminated·RRoswell Park Cancer Institute·Phase 1·NCT01550185·10 enrolled

LAM1 trial

Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01927731·48 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag

Completed· GSK logo

GSK·Phase 2·NCT01147809·130 enrolled

Thrombocytopenic Purpura1 trial

A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Completed· GSK logo

GSK·Phase 4·NCT01098487·167 enrolled

Anemia1 trial

Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia

Completed·—·Phase 2·NCT01772420·52 enrolled

5 more indications

Stem Cell1 trial

Eltrombopag for Peripheral Blood Stem Cell Harvest

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT05961410·46 enrolled

Myelodysplastic Syndrome1 trial

Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)

Completed· GSK logo

GSK·Phase 1·NCT00903422·98 enrolled

Immune Thrombocytopenia1 trial

Eltrombopag for the Treatment of Immune ThrombocytoPenia (ITP) Secondary to Chronic Lymphoproliferative Disorders (LPDs)

Completed·FFondazione Progetto Ematologia·Phase 2·NCT01610180·18 enrolled

Myeloid Leukemia1 trial

Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy

Completed·MM.D. Anderson Cancer Center·Phase 2/3·NCT01428635·21 enrolled

Unspecified1 trial

EXTEND (Eltrombopag Extended Dosing Study)

Completed· Novartis logo

Novartis·Phase 3·NCT00351468·302 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 20, 2011

PROMACTA

NDA NDA022291

Sep 27, 2018

PROMACTA KIT

NDA NDA207027

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Eltrombopag Olamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Eltrombopag Olamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Eltrombopag Olamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA207027). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Promacta Kit. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[5]

Patent Cliff

Aug 1, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7547719Jul 13, 2025

7547719*PEDJan 13, 2026

8052994Aug 1, 2027

8828430Aug 1, 2027

8071129Aug 1, 2027

7 more patents

8062665Aug 1, 2027

8052993Aug 1, 2027

8071129*PEDFeb 1, 2028

8828430*PEDFeb 1, 2028

8052993*PEDFeb 1, 2028

8052994*PEDFeb 1, 2028

8062665*PEDFeb 1, 2028

Promacta Kit

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Acute Myeloid Leukemia2 trials

LAM1 trial

Safety and Efficacy1 trial

Thrombocytopenic Purpura1 trial

Anemia1 trial

Stem Cell1 trial

Myelodysplastic Syndrome1 trial

Immune Thrombocytopenia1 trial

Myeloid Leukemia1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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