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omacetaxine

Trade name: synribo

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Oct 26, 2012

Cephalotaxine is an active metabolite of omacetaxine mepesuccinate also known as omacetaxine. In most patients the levels of cephalotaxine are undetectable. Omacetaxine mepesuccinate is a first-in-class cephalotaxine demonstrating clinical activity in chronic myeloid leukemia. — NCATS

Clinical trial activity

43 trials · 46 clinical orgs · 1 marketing orgs

Phase 1
10
Phase 2
34
Phase 3
10
Phase 4
0

Earliest trial started Sep 1, 1994 (NCT00002574)

Timeline

1990s

  1. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  3. Mar 10, 2006

    Orphan Drug Designation

2010s

  1. Oct 26, 2012

    Teva — Earliest FDA Approval

  2. Oct 26, 2012

    Teva — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • RibosomeINHIBITOR

    Ribosome inhibitor

    Inhibition of protein synthesis independent of direct BCR-ABL binding

  • Unspecified targetOTHER

    Protein synthesis inhibitor

    Inhibition of protein synthesis independent of direct BCR-ABL binding

Approval history

  • approvedAcceleratedFast trackOct 26, 2012

Chemistry & pharmacology

Loading structure…

SMILES

COC1=C[C@]23CCCN2CCC4=C(C=C5OCOC5=C4)[C@@H]3[C@@H]1O
Mol. weight
315.3636 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • (2'r,3s,4s,5r)-(−)-homoharringtonine
  • (2'r,3s,4s,5r)-(−)-homoharringtonine
  • ceflatonin
  • cgx-635
  • cgx-635
  • cgx-635
  • hht
  • hht
  • homoharringtonin
  • homoharringtonin
  • homoharringtonine
  • homoharringtonine
  • homoharringtonine
  • homoharringtonine
  • homoharringtonine
  • homoharringtonine
  • (−)-homoharringtonine
  • (−)-homoharringtonine
  • homoharringtonine, 3h-labeled, (3(r))-isomer
  • nsc 141633
  • nsc-141633
  • omacetaxine
  • omacetaxine
  • omacetaxine
  • omacetaxine mepesuccinate
  • omacetaxine mepesuccinate
  • omacetaxine mepesuccinate
  • omacetaxine mepesuccinate
  • omacetaxine mepesuccinate
  • omacetaxine mepesuccinate
  • omacetaxine mepesuccinate
  • omacetaxine mepesuccinate
  • omacetaxine mepesuccinate
  • synribo
  • synribo
  • synribo
  • synribo

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07163910Phase 2Apr 20, 2025Nantong University, Southeast University, The First People Hospital of Nantong City
NCT06855810Phase 2/Phase 3 (Phase 3)Mar 31, 2025China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences
NCT06742463Phase 2Dec 31, 2024Zhejiang University
NCT06744556Phase 2Dec 20, 2024China Academy of Chinese Medical Sciences
NCT06483906Phase 2Jul 2, 2024Jiao Tong University
NCT06361329Phase 3Apr 30, 2024Zhejiang University
NCT06221683Phase 2Jan 1, 2024Soochow University
NCT05941585N/AJul 31, 2023China Academy of Chinese Medical Sciences
NCT05805072N/AMay 1, 2023Soochow University
NCT05805098Phase 2/Phase 3 (Phase 3)Mar 1, 2023Soochow University
NCT05726110Phase 3Jan 29, 2023Antengene Corporation, Shanxi Bethune Hospital
NCT04926285Phase 1Nov 15, 2021University of Illinois at Chicago
NCT04874194Phase 1/Phase 2 (Phase 2)Oct 31, 2021University of Texas at Houston
NCT04743115Phase 1Feb 28, 2021Government of China
NCT04505995N/AJan 1, 2020Air Force Military Medical University, China, Hebei University, Qingdao University, Shandong University, Tai'an Central Hospital
NCT04248595Phase 3Dec 1, 2019Southeast University
NCT04126681Phase 2Oct 21, 2019Ascentage Pharma Group Inc., Peking University
NCT03873311Phase 3Sep 1, 2019China Medical University
NCT04087967Phase 3Apr 1, 2019Changzhou No.2 People's Hospital, Huai'an Second People's Hospital, Jingjiang People's Hospital, Kunming Medical University, Soochow University, The First People's Hospital of Lianyungang, Zhangjiagang First People's Hospital
NCT04083911Phase 3Apr 1, 2019Changzhou No.2 People's Hospital, Jingjiang People's Hospital, Kunming Medical University, Soochow University, The First People's Hospital of Lianyungang, The Second People's Hospital of Huai'an, Zhangjiagang First People's Hospital
Showing 20 of 43 trials
Page 1 / 3

Organizations

Research & Development (46)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of Texas at HoustonAcademic/Hospital11511994
TevaFor profit10422006
National Cancer Institute (NCI)Government7521994
Soochow UniversityAcademic/Hospital6632019
ChemGenex PharmaceuticalsFor profit4222005
CephalonFor profit3012006
Changzhou No.2 People's HospitalAcademic/Hospital3012019
China Academy of Chinese Medical SciencesAcademic/Hospital3332023
Jingjiang People's HospitalAcademic/Hospital2012019
Kunming Medical UniversityAcademic/Hospital2012019
Southeast UniversityAcademic/Hospital2222019
The First People's Hospital of LianyungangAcademic/Hospital2012019
The Second People's Hospital of Huai'anAcademic/Hospital2012019
The University of Hong KongAcademic/Hospital2212017
University of Illinois at ChicagoAcademic/Hospital2222015
Zhangjiagang First People's HospitalAcademic/Hospital2012019
Zhejiang UniversityAcademic/Hospital2222024
Air Force Military Medical University, ChinaAcademic/Hospital1112020
Anhui Medical UniversityAcademic/Hospital1012019
Antengene CorporationFor profit1012023
46 organizations
Page 1 / 3

Marketing (1)

OrganizationOrg typeRelationshipDate
TevaFor profitNDAOct 26, 2012