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dactinomycin

Trade name: cosmegen

Small moleculeapproved

Approved

Dec 10, 1964

Dactinomycin (actinomycin D) was isolated from Streptomyces by Selman Waksman in 1940s. The antibiotic shows anti-cancer activity; it was approved by FDA for the treatment of different cancer conditions among which are Ewing's sarcoma, Wilm's tumor, gestational trophoblastic disease, etc. Dactinomycin exerts its action by binding to DNA (preferably to GC motif) and thus inhibiting transcription. — NCATS

Clinical trial activity

61 trials · 81 clinical orgs · 14 marketing orgs

Phase 1
4
Phase 2
54
Phase 3
32
Phase 4
1

Earliest trial started Oct 1, 1991 (NCT00002489)

Timeline

1960s

  1. Dec 10, 1964

    Merck — Earliest FDA Approval

  2. Dec 10, 1964

    Merck — NDA Organization

  3. Dec 10, 1964

    Recordati — NDA Secondary Org

1990s

  1. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1992

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Mar 16, 2010

    West-Ward Pharmaceutical — Marketing Organization

  2. Mar 16, 2010

    Hikma — Marketing Organization

  3. Aug 23, 2013

    Sankyo — Marketing Organization

  4. Aug 23, 2013

    Lutipold — Marketing Organization

  5. Aug 23, 2013

    Daiichi Sankyo — Marketing Organization

  6. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  7. Nov 9, 2017

    Mylan — Marketing Organization

  8. Nov 9, 2017

    Auromedics Pharma — Marketing Organization

  9. Nov 9, 2017

    Eugia Pharma — Marketing Organization

  10. May 20, 2019

    X Gen Pharmaceuticals — Marketing Organization

  11. Jul 16, 2019

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

2020s

  1. Nov 13, 2020

    Meitheal — Marketing Organization

  2. Nov 13, 2020

    Eu Yan Sang — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNABLOCKER

    DNA blocker

Approval history

  • approvedPriority reviewDec 10, 1964

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[C@H]1NC(=O)[C@@H](NC(=O)C2=CC=C(C)C3=C2N=C4C(O3)=C(C)C(=O)C(N)=C4C(=O)N[C@H]5[C@@H](C)OC(=O)[C@H](C(C)C)N(C)C(=O)CN(C)C(=O)[C@@H]6CCCN6C(=O)[C@H](NC5=O)C(C)C)[C@@H](C)OC(=O)[C@H](C(C)C)N(C)C(=O)CN(C)C(=O)[C@@H]7CCCN7C1=O
Mol. weight
1255.417 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 2-amino-n,n'-bis(hexadecahydro-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxo-1h-pyrrolo(2,1-i)(1,4,7,10,13)oxatetra-azacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-3h-phenoxazine-1,9-dicarboxamide
  • 2-amino-n,n'-bis(hexadecahydro-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxo-1h-pyrrolo(2,1-i)(1,4,7,10,13)oxatetra-azacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-3h-phenoxazine-1,9-dicarboxamide
  • actactinomycin a iv
  • actd
  • actd
  • actinomycin
  • actinomycin
  • actinomycin 7
  • actinomycin c1
  • actinomycin c1
  • actinomycin d
  • actinomycin d
  • actinomycin d
  • actinomycin d
  • actinomycin d
  • actinomycin-d
  • actinomycin-d
  • actinomycin iv
  • actinomycin iv
  • c1
  • c1
  • chounghwamycin b
  • cosmegen
  • cosmegen
  • cosmegen
  • cosmegen lyovac
  • cosmegen lyovac
  • dactinomicina
  • dactinomicina
  • dactinomycin
  • dactinomycin
  • dactinomycin
  • dactinomycin
  • dactinomycin
  • dactinomycin
  • dactinomycin
  • dactinomycin
  • dactinomycin
  • dactinomycin d
  • dactinomycine
  • dactinomycine
  • dactinomycinum
  • dactinomycinum
  • dilactone actinomycin d acid
  • dilactone actinomycindioic d acid
  • gnf-pf-1977
  • gnf-pf-1977
  • gnf-pf-2290
  • gnf-pf-2290
  • meractinomycin
  • meractinomycin
  • meractinomycin
  • oncostatin k

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07194044Phase 1Oct 31, 2025National Pediatric Cancer Foundation, University of South Florida
NCT06401330Phase 3Dec 31, 2024National Cancer Institute (NCI)
NCT06647953Phase 3Dec 17, 2024National Cancer Institute (NCI)
NCT06023641Phase 1/Phase 2 (Phase 2)Nov 30, 2023St. Jude Children's Hospital
NCT06020755Phase 2Sep 30, 2023Chinese Academy of Medical Sciences, Dalian Maternity and Child Care Hospital, Fudan University, Gansu Provincial Maternity and Child-Care Hospital, Henan Medical University, Shanghai Junshi Bioscience Co.,Ltd., Shengjing Hospital, Sun Yat-Sen University, University of Electronic Science and Technology of China, Xiamen University
NCT06028672N/ASep 12, 2023Chinese Academy of Medical Sciences, Dalian Maternity and Child Care Hospital, Fudan University, Gansu Provincial Maternity and Child-Care Hospital, Henan Medical University, Shanghai Junshi Bioscience Co.,Ltd., Shengjing Hospital, Sun Yat-Sen University, University of Electronic Science and Technology of China, Xiamen University
NCT05304585Phase 3Jun 22, 2022National Cancer Institute (NCI)
NCT04994132Phase 3Sep 13, 2021National Cancer Institute (NCI)
NCT04756713Phase 3Feb 11, 2021Federal University of Rio de Janeiro, Harvard University
NCT04562558N/ASep 29, 2020Chinese Academy of Medical Sciences, Peking University
NCT04625907Phase 1/Phase 2 (Phase 2)Sep 17, 2020University of Birmingham
NCT04388839Phase 2Jun 30, 2020National Pediatric Cancer Foundation, University of South Florida
NCT04332874Phase 2Apr 1, 2020Memorial Sloan-Kettering Cancer Center
NCT03885388Phase 2/Phase 3 (Phase 3)Mar 8, 2019Huazhong University of Science and Technology, Shandong University, Sichuan University, Zhejiang University
NCT03669783Phase 3Jan 1, 2019Aix-University of Marseille
NCT02567435Phase 3May 23, 2016National Cancer Institute (NCI)
NCT02639650Phase 3Mar 1, 2016Huazhong University of Science and Technology, Shandong University, Zhejiang University, Zhongshan Medical University
NCT01531244Phase 1/Phase 2 (Phase 2)Dec 1, 2014Washington University in St. Louis
NCT01871766Phase 2Dec 4, 2013St. Jude Children's Hospital
NCT01823315Phase 3Dec 1, 2012Huazhong University of Science and Technology, Shandong University, Zhejiang University
Showing 20 of 61 trials
Page 1 / 4

Organizations

Research & Development (81)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government261921995
Children's Cancer and Leukaemia GroupAcademic/Hospital5121998
Cornell UniversityAcademic/Hospital4421991
Chinese Academy of Medical SciencesAcademic/Hospital3222020
Gynecologic Oncology GroupAcademic/Hospital3321999
Huazhong University of Science and TechnologyAcademic/Hospital3112012
Institut Gustave RoussyAcademic/Hospital3111995
Shandong UniversityAcademic/Hospital3012012
Societe Francaise Oncologie PediatriqueAcademic/Hospital3021998
University of BristolAcademic/Hospital3021995
University of LeicesterAcademic/Hospital3311993
Zhejiang UniversityAcademic/Hospital3212012
Barts & The London NHS TrustAcademic/Hospital2112006
Dalian Maternity and Child Care HospitalAcademic/Hospital2022023
Fudan UniversityAcademic/Hospital2022023
Gansu Provincial Maternity and Child-Care HospitalAcademic/Hospital2022023
Gesellschaft fur Padiatrische Onkologie und Hamatologie - GermanyAcademic/Hospital2012001
Harvard UniversityAcademic/Hospital2222003
Henan Medical UniversityAcademic/Hospital2022023
Japan Rhabdomyosarcoma Study GroupAcademic/Hospital2212004
81 organizations
Page 1 / 5

Marketing (16)

OrganizationOrg typeRelationshipDate
Auromedics PharmaFor profitMKTGNov 9, 2017
Daiichi SankyoFor profitMKTGAug 23, 2013
Eu Yan SangFor profitMKTGNov 13, 2020
Eugia PharmaFor profitMKTGNov 9, 2017
HikmaFor profitSYNMar 16, 2010
HikmaFor profitMKTGMar 16, 2010
LutipoldFor profitMKTGAug 23, 2013
MeithealFor profitMKTGNov 13, 2020
MerckFor profitNDADec 10, 1964
MylanFor profitMKTGNov 9, 2017
RecordatiFor profitNDA2Dec 10, 1964
SankyoFor profitMKTGAug 23, 2013
West-Ward PharmaceuticalFor profitMKTGMar 16, 2010
X Gen PharmaceuticalsFor profitSYNMay 20, 2019
X Gen PharmaceuticalsFor profitMKTGMay 20, 2019
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGJul 16, 2019