eltrombopag

Trade name: promacta

Small moleculeapprovedOrphan Drug FDA

Approved

Nov 20, 2008

Eltrombopag is a thrombopoietin (TPO) nonpeptide mimetic administered orally that activates the TPO receptor by binding to the transmembrane domain and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. Eltrombopag under brand name promacta is approved for the treatment of the low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines, or surgery to remove the spleen, have not worked well enough. ITP is a condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood. Eltrombopag has also been approved for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy and to treat patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. — NCATS

Clinical trial activity

150 trials · 124 clinical orgs · 16 marketing orgs

Phase 1
29
Phase 2
107
Phase 3
27
Phase 4
15

Earliest trial started Feb 1, 2005 (NCT00102726)

Timeline

2000s

  1. Jan 1, 2005

    GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2006

    Novartis — Earliest Phase 3 Sponsor(trial)

  4. May 5, 2008

    Orphan Drug Designation

  5. Nov 20, 2008

    GlaxoSmithKline — Earliest FDA Approval

  6. Nov 20, 2008

    GlaxoSmithKline — NDA Organization

  7. Nov 20, 2008

    Novartis — NDA Secondary Org

  8. Nov 20, 2008

    Novartis — Marketing Organization

2010s

  1. Jul 6, 2016

    Hetero Labs Ltd — Marketing Organization

  2. Nov 28, 2017

    Actavis — Marketing Organization

  3. Nov 28, 2017

    Allergan PLC (2015) — Marketing Organization

  4. Feb 16, 2018

    Teva — Marketing Organization

2020s

  1. Oct 3, 2022

    Teva — NDA Secondary Org

  2. Apr 18, 2024

    Annora Pharma — Marketing Organization

  3. Apr 30, 2024

    Amneal Pharmaceuticals — Marketing Organization

  4. May 7, 2025

    Dr. Reddy's Laboratories — Marketing Organization

  5. Aug 5, 2025

    Somerset Therapeutics LLC — Marketing Organization

  6. Jan 14, 2026

    MSN Laboratories — Marketing Organization

  7. Jan 14, 2026

    Somerset Pharmaceuticals — Marketing Organization

  8. Jan 14, 2026

    Zydus Discovery DMCC — Marketing Organization

  9. Apr 8, 2026

    ZENARA — Marketing Organization

  10. Apr 8, 2026

    Hikma — Marketing Organization

  11. Apr 28, 2026

    Biocon Limited — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedNov 20, 2008

Chemistry & pharmacology

Loading structure…

SMILES

CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O.NCCO.NCCO
Mol. weight
564.64 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag
  • eltrombopag olamine
  • eltrombopag olamine
  • eltrombopag olamine
  • eltrombopag olamine
  • eltrombopag olamine
  • eltrombopag olamine
  • eltrombopagum
  • ppromacta
  • promacta
  • promacta
  • promacta
  • promacta
  • revolade
  • revolade
  • revolade
  • revolade
  • sb497115
  • sb497115
  • sb 497115
  • sb-497115
  • sb-497115
  • sb-497 115
  • sb-497115-gr
  • sb-497115-gr

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07189910Phase 4Dec 1, 2025Huazhong University of Science and Technology
NCT07113743Phase 1/Phase 2 (Phase 2)Sep 10, 2025National Institute of Allergy and Infectious Diseases (NIAID)
NCT07093606N/AJul 14, 2025Sohag University
NCT06834451Phase 4Mar 1, 2025
NCT06630221Phase 2Jan 1, 2025Case Western Reserve University
NCT06531018Phase 1/Phase 2 (Phase 2)Jan 1, 2025Dhaka Medical College, Renata
NCT06607367Phase 1/Phase 2 (Phase 2)Oct 30, 2024Melbourne Health
NCT06345495Phase 2Oct 1, 2024Incyte, University of Texas at Houston
NCT06493981Phase 3Jul 31, 2024Assiut University
NCT06479291N/AJul 31, 2024Dr. Stanley Ho Medical Foundation, Macau, Fudan University, Government of China, Macau University of Science and Technology Hospital
NCT05961410Phase 2Aug 15, 2023National Taiwan University, Novartis
NCT05975996Phase 2Jul 10, 2023China Academy of Chinese Medical Sciences
NCT05907499Phase 3Jul 1, 2023Soochow University
NCT05924152Phase 1Jun 29, 2023Mirati Therapeutics Inc.
NCT05653219Phase 3Dec 30, 2022Novartis
NCT05583838Phase 4Oct 31, 2022China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences, Dalian Medical University, Guangzhou Medical University, Harbin Medical University, Henan Medical University, Inner Mongolia Medical University, Jiao Tong University, Kashgar 1st People's Hospital, Kunming Medical University, North China University of Science and Technology Affiliated Hospital, Shaanxi Provincial People's Hospital, Shanxi Medical University, Sunshine Lake Pharma Co., Ltd., Xijing Hospital, Xinjiang Medical University, Yuyao People's Hospital of Zhejiang Province
NCT05466201Phase 2/Phase 3 (Phase 3)Oct 22, 2022Soochow University
NCT05438875Phase 2Jun 24, 2022Capital Medical University, Government of China, Peking University
NCT05369377Phase 2Jun 1, 2022Capital Medical University, Government of China, Peking University, Shandong University
NCT05286164Phase 2Apr 30, 2022Novartis, Tel Aviv University
Showing 20 of 150 trials
Page 1 / 8

Organizations

Research & Development (124)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit492942005
NovartisFor profit361942006
National Heart, Lung, and Blood Institute (NHLBI)Government8812009
University of Texas at HoustonAcademic/Hospital7712010
Chinese Academy of Medical SciencesAcademic/Hospital5322016
Shandong UniversityAcademic/Hospital5322016
Assiut UniversityAcademic/Hospital4422017
China Academy of Chinese Medical SciencesAcademic/Hospital4322018
Peking UniversityAcademic/Hospital4422020
Case Western Reserve UniversityAcademic/Hospital3212012
Cornell UniversityAcademic/Hospital3312009
Government of ChinaGovernment3022022
Guangzhou Medical UniversityAcademic/Hospital3032018
Harvard UniversityAcademic/Hospital3232011
Henan Medical UniversityAcademic/Hospital3022018
Kunming Medical UniversityAcademic/Hospital3022018
National Cancer Institute (NCI)Government3022012
Soochow UniversityAcademic/Hospital3322018
Tel Aviv UniversityAcademic/Hospital3312013
Associazione Qol-oneAcademic/Hospital2212011
124 organizations
Page 1 / 7

Marketing (22)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGNov 28, 2017
Allergan PLC (2015)For profitMKTGNov 28, 2017
Amneal PharmaceuticalsFor profitMKTGApr 30, 2024
Amneal PharmaceuticalsFor profitSYNJan 14, 2026
Annora PharmaFor profitMKTGApr 18, 2024
Biocon LimitedFor profitMKTGApr 28, 2026
Dr. Reddy's LaboratoriesFor profitMKTGMay 7, 2025
Dr. Reddy's LaboratoriesFor profitSYNMar 16, 2026
GlaxoSmithKlineFor profitNDANov 20, 2008
Hetero Labs LtdFor profitMKTGJul 6, 2016
HikmaFor profitMKTGApr 8, 2026
MSN LaboratoriesFor profitMKTGJan 14, 2026
NovartisFor profitNDA2Nov 20, 2008
NovartisFor profitMKTGNov 20, 2008
Somerset PharmaceuticalsFor profitMKTGJan 14, 2026
Somerset Therapeutics LLCFor profitMKTGAug 5, 2025
TevaFor profitSYNOct 3, 2022
TevaFor profitMKTGFeb 16, 2018
TevaFor profitNDA2Oct 3, 2022
TevaFor profitSYNNov 29, 2023
ZENARAFor profitMKTGApr 8, 2026
Zydus Discovery DMCCFor profitMKTGJan 14, 2026