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romiplostim

Trade name: nplate

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 22, 2008

Romiplostim, sold under the brand name Nplate among others, is a fusion protein analog of thrombopoietin, a hormone that regulates platelet production. — Wikipedia

Clinical trial activity

114 trials · 84 clinical orgs · 1 marketing orgs

Phase 1
26
Phase 2
84
Phase 3
27
Phase 4
6

Earliest trial started Jul 1, 1998 (NCT00003720)

Timeline

1990s

  1. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Mar 27, 2003

    Orphan Drug Designation

  3. Aug 22, 2008

    Amgen — Earliest FDA Approval

  4. Aug 22, 2008

    Amgen — Marketing Organization

  5. Aug 22, 2008

    Amgen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 22, 2008

Chemistry & pharmacology

Loading structure…

SMILES

Cc1cc(C)c(/C=C2\C(=O)Nc3ccccc32)[nH]1
Mol. weight
238.29 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 3-(2,4-dimethylpyrrol-5-yl)methylidene-indolin-2-one
  • amg531
  • amg531
  • amg 531
  • amg-531
  • amgen megakaryopoiesis protein 531
  • nplate
  • nplate
  • nplate
  • nplate
  • romiplostim
  • romiplostim
  • romiplostim
  • romiplostim
  • romiplostim
  • romiplostim
  • romiplostim
  • romiplostim
  • romiplostim
  • romiplostim
  • romiplostim
  • semaxanib
  • semaxanib
  • semaxanib
  • semaxanib
  • semaxinib
  • semaxinib
  • semaxinib
  • su5416
  • su5416
  • su5416
  • su 5416
  • su-5416
  • su-5416
  • su-5416

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07278661Phase 2Jan 1, 2026University of Nantes
NCT07185893N/ASep 30, 2025Hebei University
NCT07162519N/ASep 20, 2025Hebei University, Huazhong University of Science and Technology, Shandong University, Tangshan People's Hospital, Tianjin Medical University
NCT07128576Phase 2Sep 15, 2025Southern Medical University
NCT07206823N/ASep 1, 2025Soochow University
NCT07063225Phase 2Aug 31, 2025China Academy of Chinese Medical Sciences, Henan Medical University, Kunming Medical University, Tianjin Medical University
NCT07001254Phase 2Jul 31, 2025Department of Health and Human Services, Food and Drug Administration, University of Iowa
NCT07043894Phase 2Jul 1, 2025Chinese Academy of Medical Sciences
NCT06992128Phase 2May 22, 2025Baoding First Center Hospital, Bengbu Medical College, Changzhi Medical College, China Academy of Chinese Medical Sciences, China Medical University, Dalian Medical University, Nantong University, North China University of Science and Technology Affiliated Hospital, North Sichuan Medical University, Qingdao University, Weifang People's Hospital
NCT06898983Phase 2Mar 31, 2025Anhui Medical University
NCT06759636Phase 3Jan 21, 2025Nanjing Medical University
NCT06693791Phase 2Dec 1, 2024Anhui Medical University
NCT06686927Phase 2Nov 20, 2024China Academy of Chinese Medical Sciences, Huazhong University of Science and Technology, Shandong University, Soochow University
NCT06613880Phase 2Oct 24, 2024China Academy of Chinese Medical Sciences, Qilu Pharmaceutical Co., Ltd.
NCT06345495Phase 2Oct 1, 2024Incyte, University of Texas at Houston
NCT06535685Phase 4Aug 2, 2024Chinese Academy of Medical Sciences
NCT06516484Phase 4Jul 30, 2024Chinese Academy of Medical Sciences
NCT06440824Phase 3Jun 1, 2024Shandong University
NCT06658834Phase 2Jun 1, 2024Bengbu Medical College, Changzhi Medical College, China Academy of Chinese Medical Sciences, China Medical University, Dalian Medical University, Guizhou Medical University, Kunming Medical University, Nantong University, North China University of Science and Technology Affiliated Hospital, Qingdao University, Suining Central Hospital, The First People's Hospital of Yunan Province, Weifang People's Hospital
NCT07048249Early Phase 1 (Phase 1)Jan 26, 2024University of Cincinnati
Showing 20 of 114 trials
Page 1 / 6

Organizations

Research & Development (84)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit352552004
National Cancer Institute (NCI)Government281032000
Kyowa Hakko KirinFor profit8822006
University of Texas at HoustonAcademic/Hospital6312000
China Academy of Chinese Medical SciencesAcademic/Hospital5412024
Chinese Academy of Medical SciencesAcademic/Hospital5422015
University of ChicagoAcademic/Hospital5222000
SugenFor profit4241998
Case Western Reserve UniversityAcademic/Hospital3312000
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital3312020
Shandong UniversityAcademic/Hospital3132024
Temple UniversityAcademic/Hospital3112000
University of California, Los AngelesAcademic/Hospital3232000
Ain Shams UniversityAcademic/Hospital2212013
Anhui Medical UniversityAcademic/Hospital2212024
AO GENERIUMFor profit2212021
Bengbu Medical CollegeAcademic/Hospital2012024
Changzhi Medical CollegeAcademic/Hospital2012024
China Medical UniversityAcademic/Hospital2012024
City of Hope National Medical CenterAcademic/Hospital2222000
84 organizations
Page 1 / 5

Marketing (2)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGAug 22, 2008
AmgenFor profitNDAAug 22, 2008