mechlorethamine

Trade name: mustargen

Small moleculeapproved

Approved

Mar 15, 1949

Mechlorethamine also known as mustine, brand name MUSTARGEN administered intravenously is the prototype anticancer chemotherapeutic drug, is indicated for the palliative treatment of Hodgkin's disease (Stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma. In 2013 was approved orphan drug Valchlor (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Mechlorethamine belongs to the group of nitrogen mustard alkylating agents. Alkylating agents work by three different mechanisms: attachment of alkyl groups to DNA bases, resulting in the DNA being fragmented by repair enzymes in their attempts to replace the alkylated bases, 2) DNA damage via the formation of cross-links (bonds between atoms in the DNA) which prevents DNA from being separated for synthesis or transcription, and 3) the induction of mispairing of the nucleotides leading to mutations all of which achieve the same end result - disruption of DNA function and cell death. — NCATS

Clinical trial activity

24 trials · 48 clinical orgs · 3 marketing orgs

Phase 1
2
Phase 2
21
Phase 3
4
Phase 4
1

Earliest trial started Feb 1, 1989 (NCT00002463)

Timeline

1940s

  1. Mar 15, 1949

    Merck — Earliest FDA Approval

  2. Mar 15, 1949

    Recordati — NDA Secondary Org

  3. Mar 15, 1949

    Merck — NDA Organization

1980s

  1. Jan 1, 1989

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1989

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Aug 23, 2013

    Helsinn — NDA Secondary Org

  2. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

    Alkylating agent

Approval history

  • approvedPriority reviewMar 15, 1949

Chemistry & pharmacology

Loading structure…

SMILES

CN(CCCl)CCCl
Mol. weight
156.06 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral, Topical
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

Yes

Black box warning

Sources

Also known as

  • 2,2'-dichloro-n-methyldiethylamine
  • 2,2'-dichloro-n-methyldiethylamine
  • beta,beta'-dichlorodiethyl-n-methylamine
  • beta,beta'-dichlorodiethyl-n-methylamine
  • bis(2-chloroethyl)methylamine
  • bis(2-chloroethyl)methylamine
  • bis(beta-chloroethyl)methylamine
  • bis(beta-chloroethyl)methylamine
  • chlormethine
  • chlormethine
  • chlormethine
  • chlormethine
  • chlormethine
  • hn2 hcl
  • hn2 hcl
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine
  • mechlorethamine hcl
  • mechlorethamine hcl
  • mechlorethamine hcl
  • mechlorethamine hydrochloride
  • mechlorethamine hydrochloride
  • mechlorethamine hydrochloride
  • mechlorethamine hydrochloride
  • methylbis(2-chloroethyl)amine
  • methylbis(2-chloroethyl)amine
  • methylbis(beta-chloroethyl)amine
  • methylbis(beta-chloroethyl)amine
  • mustargen
  • mustargen
  • mustargen
  • mustargen
  • mustine
  • mustine
  • mustine
  • nitrogen mustard
  • nitrogen mustard
  • nitrogen mustard
  • nitrogen mustard
  • nitrogen mustard n-oxide hcl
  • n-methyl-bis(2-chloroethyl)amine
  • n-methyl-bis(2-chloroethyl)amine
  • n-methyl-bis(beta-chloroethyl)amine
  • n-methyl-bis(beta-chloroethyl)amine
  • tinefcon
  • valchlor
  • valchlor
  • β,β'-dichlorodiethyl-n-methylamine
  • β,β'-dichlorodiethyl-n-methylamine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06149247Phase 2Dec 5, 2023Soligenix
NCT05303480N/ADec 7, 2021Leiden University, Recordati
NCT04218825Phase 2Jul 31, 2020European Organisation for Research and Treatment of Cancer, University of Birmingham, University of Lausanne
NCT04026269Phase 1/Phase 2 (Phase 2)Jul 30, 2019People's Liberation Army of China
NCT03288818Phase 2Aug 31, 2018Actelion, Thomas Jefferson University
NCT03417141Phase 2Apr 1, 2018Actelion, Mayo Clinic
NCT03380026Phase 2Dec 13, 2017Rochester Skin Lymphoma Medical Group, PLLC, University of Rochester
NCT02968446Early Phase 1 (Phase 1)Nov 17, 2016Case Western Reserve University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
NCT02881749Phase 2Sep 1, 2016Actelion, Thomas Jefferson University
NCT01373567Phase 4Dec 1, 2010Bhatia Skin Center, Bima Nagar, Indore, Dr. D. Y. Patil Dental College & Hospital, Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014, Durgabai Deshmukh Hospital & Research Center, Lokmanya Tilak Municipal Medical College, Medipoint Hospitals Pvt. Ltd., M.S. Diabetes and Shirdi Skin care centre 6/1, 80 Feet Road, Opp. Krishna Sagar Hotel, Indiranagar, Bangalore, Navprabhat Chambers,Opp, Nagpur, NKP Salve Institute and Lata Mangeshkar Hospital, Nagpur, Piramal, Postgraduate Institute of Medical Education and Research, PSG Hospital, Peelamedu, Rajiv Gandhi University of Health Sciences, Renova Skin & Laser Clinic, Jaipur, Sai Life Sciences, Sheth VS General Hospital, Skin Care Clinic, Nagpur, Skin & Laser Center, New Delhi, Sri Skin Care & Laser Clinic, Chowk-Lucknow, Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar,Indore
NCT00846742Phase 2Jun 5, 2009St. Jude Children's Hospital
NCT00574496Phase 2Nov 1, 2007Cornell University, National Cancer Institute (NCI)
NCT00535470Phase 2Jul 1, 2007Ceptaris, Temple University
NCT00352027Phase 2Jul 1, 2006St. Jude Children's Hospital
NCT00168064Phase 2May 1, 2006Ceptaris, Temple University
NCT00041210Phase 3Oct 1, 2001Inova Health System
NCT00145600Phase 2Mar 1, 2000St. Jude Children's Hospital
NCT00003389Phase 3Apr 1, 1999Eastern Cooperative Oncology Group, National Cancer Institute (NCI), Stanford University
NCT00003262Phase 2May 1, 1997Centro di Riferimento Oncologico - Aviano
NCT00002714Phase 2Apr 1, 1995National Cancer Institute (NCI), Stanford University
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (48)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government5021989
ActelionFor profit3012016
European Organisation for Research and Treatment of CancerAcademic/Hospital3321989
Stanford UniversityAcademic/Hospital3221989
St. Jude Children's HospitalAcademic/Hospital3312000
CeptarisFor profit2212006
Temple UniversityAcademic/Hospital2012006
Thomas Jefferson UniversityAcademic/Hospital2212016
Bhatia Skin Center, Bima Nagar, IndoreAcademic/Hospital1012010
Case Western Reserve UniversityAcademic/Hospital1112016
Centre Medical de BlignyAcademic/Hospital1011993
Centro di Riferimento Oncologico - AvianoAcademic/Hospital1111997
Cornell UniversityAcademic/Hospital1112007
Dr. D. Y. Patil Dental College & HospitalAcademic/Hospital1012010
Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014Academic/Hospital1012010
Durgabai Deshmukh Hospital & Research CenterAcademic/Hospital1012010
Eastern Cooperative Oncology GroupAcademic/Hospital1111999
Inova Health SystemAcademic/Hospital1112001
Institut BergoniéAcademic/Hospital1011993
Leiden UniversityAcademic/Hospital1112021
48 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
HelsinnFor profitNDA2Aug 23, 2013
MerckFor profitNDAMar 15, 1949
RecordatiFor profitNDA2Mar 15, 1949