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lomustine

Small moleculeapproved

Approved

Aug 4, 1976

Lomustine is used in the treatment of certain neoplastic diseases. Although it is generally agreed that lomustine alkylates DNA and RNA, it is not cross resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins. Common adverse reactions include delayed myelosupression, nausea, vomiting, stomatitis, and alopecia. — NCATS

Clinical trial activity

104 trials · 140 clinical orgs · 4 marketing orgs

Phase 1
19
Phase 2
78
Phase 3
40
Phase 4
0

Earliest trial started Jul 1, 1994 (NCT00002569)

Timeline

1970s

  1. Aug 4, 1976

    Earliest FDA Approval

  2. Aug 4, 1976

    Corden Pharma — NDA Secondary Org

  3. Aug 4, 1976

    Azurity — Marketing Organization

1990s

  1. Jan 1, 1994

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1996

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Oct 27, 2025

    CARNEGIE — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

Approval history

  • approvedAug 4, 1976

Chemistry & pharmacology

Loading structure…

SMILES

ClCCN(N=O)C(=O)NC1CCCCC1
Mol. weight
233.695 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

  • 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea
  • 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea
  • 1-(2-chloroethyl)-3-cyclohexylnitrosourea
  • 1-(2-chloroethyl)-3-cyclohexylnitrosourea
  • belustine
  • belustine
  • belustine
  • ccnu
  • ccnu
  • cecenu
  • cecenu
  • ceenu
  • ceenu
  • ceenu
  • chloroethylcyclohexylnitrosourea
  • chloroethylcyclohexylnitrosourea
  • chloroethylcyclohexylnitrosourea
  • cinu
  • cinu
  • cyclohexyl chloroethyl nitrosourea
  • cyclohexyl chloroethyl nitrosourea
  • lomustin
  • lomustina
  • lomustina
  • lomustine
  • lomustine
  • lomustine
  • lomustine
  • lomustine
  • lomustine
  • lomustine
  • lomustine
  • lomustine
  • lomustine
  • lomustine
  • lomustinum
  • lomustinum
  • n-(2-chloroethyl)-n'-cyclohexyl-n-nitrosourea
  • n-(2-chloroethyl)-n'-cyclohexyl-n-nitrosourea

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07120984Phase 2Jan 30, 2026Philogen S.p.A.
NCT07100730Phase 3Nov 2, 2025Telix
NCT07145112Phase 1Oct 1, 2025National Cancer Institute (NCI), University of California, Davis
NCT06325683Phase 2May 31, 2025National Cancer Institute (NCI)
NCT06673459Phase 3Dec 1, 2024Anhui Medical University, Fujian Medical University, Huazhong University of Science and Technology, Jiao Tong University, Soochow University, Southern Medical University, Zhejiang University
NCT06336291Phase 2Jun 30, 2024Philogen S.p.A.
NCT06419946Phase 3May 15, 2024Aarhus University, Gävle Hospital, Kalmar County Hospital, Karlstad University, Karolinska Institute, Linkoping University, Lund University, Norwegian University of Science and Technology, Orebro University, Ryhov County Hospital, Sorlandet Hospital HF, University of Bergen, University of Gothenburg, University of Oslo, University of Stavanger, University of Ulm, Vastra Gotaland Region
NCT05904119Phase 3Mar 31, 2024European Organisation for Research and Treatment of Cancer
NCT06177964Phase 2Dec 31, 2023Duke University, Istari Oncology, Inc.
NCT05902169Phase 3Nov 5, 2023CarThera
NCT05410301N/AApr 30, 2023University of Iowa
NCT05667402N/AJan 15, 2023Jiao Tong University
NCT05382338Phase 3Dec 9, 2022National Cancer Institute (NCI)
NCT05324501Phase 1Oct 19, 2022Biodexa Pharmaceuticals
NCT05304663Phase 1Jun 1, 2022Philogen S.p.A.
NCT05095376Phase 3May 6, 2022National Cancer Institute (NCI), NRG Oncology
NCT05017610Early Phase 1 (Phase 1)Dec 31, 2021Emory University
NCT04933942Phase 2Dec 31, 2021Amgen, European Organisation for Research and Treatment of Cancer
NCT04863950Phase 2Nov 30, 2021University of Texas, San Antonio
NCT04910022Phase 1/Phase 2 (Phase 2)Sep 30, 2021Nerviano Medical Sciences
Showing 20 of 104 trials
Page 1 / 6

Organizations

Research & Development (140)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government261041994
European Organisation for Research and Treatment of CancerAcademic/Hospital8521996
University of Texas at HoustonAcademic/Hospital6531997
Mayo ClinicAcademic/Hospital5021994
Case Western Reserve UniversityAcademic/Hospital4411997
Philogen S.p.A.For profit4422020
Cornell UniversityAcademic/Hospital3321997
Duke UniversityAcademic/Hospital3322014
Eastern Cooperative Oncology GroupAcademic/Hospital3011994
Eli LillyFor profit3332005
Harvard UniversityAcademic/Hospital3132007
North Central Cancer Treatment GroupAcademic/Hospital3011994
NRG OncologyAcademic/Hospital3111998
Radiation Therapy Oncology GroupAcademic/Hospital3311994
AstraZenecaFor profit2222007
Canadian Cancer Trials GroupAcademic/Hospital2011994
Capital Medical UniversityAcademic/Hospital2022015
CelgeneFor profit2022006
Children's Cancer and Leukaemia GroupAcademic/Hospital2212001
Emory UniversityAcademic/Hospital2122019
140 organizations
Page 1 / 7

Marketing (4)

OrganizationOrg typeRelationshipDate
AzurityFor profitMKTGAug 4, 1976
CARNEGIEFor profitMKTGOct 27, 2025
Corden PharmaFor profitNDA2Aug 4, 1976
SquibbFor profitNDA—