levamisole

Trade name: ergamisol

Small moleculeapproved

Approved

Jun 18, 1990

Levamisole (the trade name Ergamisol), an anthelminthic drug with immunological properties. It also has antitumor activity when administered with 5-fluorouracil in patients with Duke's C colorectal carcinoma; however, this use was discontinued. The mechanism of the antitumor effect is unknown but has been postulated to be related to levamisole's immunomodulatory properties. Levamisole can stimulate antibody formation to various antigens, enhance T-cell responses by stimulating T-cell activation and proliferation, potentiate monocyte and macrophage functions including phagocytosis, chemotaxis and increases motility, adherence, and chemotaxis. Levamisole inhibits alkaline phosphatase and possesses cholinergic activity. The mechanism of action of levamisole as an antiparasitic agent, for example, to treat ascariasis, relates to its agonistic activity to L-subtype nicotinic acetylcholine receptors in nematode muscles. In addition, levamisole was studied for preventing relapses of the steroid-sensitive idiopathic nephrotic syndrome (SSINS). It was shown, that alone or in combination with steroids, the drug can prolong the time to relapse and prevented recurrence during one year of treatment. However, these studies also were also discontinued. — NCATS

Clinical trial activity

24 trials · 52 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
18
Phase 3
14
Phase 4
2

Earliest trial started Jul 1, 1989 (NCT00425152)

Timeline

1980s

  1. Jan 1, 1989

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jun 18, 1990

    Johnson and Johnson — Earliest FDA Approval

  2. Jun 18, 1990

    Johnson and Johnson — NDA Secondary Org

  3. Jun 18, 1990

    Johnson and Johnson — NDA Organization

2000s

  1. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedPriority reviewJun 18, 1990

Chemistry & pharmacology

Loading structure…

SMILES

c1ccc([C@H]2CN3CCSC3=N2)cc1
Mol. weight
204.3 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • ergamisol
  • ergamisol
  • ergamisol
  • ketrax
  • ketrax
  • levamisol
  • levamisol
  • levamisol
  • levamisol
  • levamisole
  • levamisole
  • levamisole
  • levamisole
  • levamisole
  • levamisole
  • levamisole
  • levamisole
  • levamisole hcl
  • levamisole hcl
  • levamisole hcl
  • levamisole hydrochloride
  • levamisole hydrochloride
  • levamisole hydrochloride
  • levamisole hydrochloride
  • levamisole hydrochloride
  • levamisole hydrochloride
  • levamisole hydrochloride
  • levamisolum
  • levamisolum
  • levamizol
  • r-12564
  • r-12564
  • solaskil
  • solaskil
  • tcmdc-125847
  • tcmdc-125847
  • tetramisole
  • tetramisole hcl
  • tetramisole hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06252961Phase 2/Phase 3 (Phase 3)Jun 21, 2024Government of Congo, Government of France, Programme National de Lutte contre l'Onchocercose (PNLO)
NCT05772871Phase 4Apr 26, 2023Huazhong University of Science and Technology, LinkDoc Technology (Beijing) Co. Ltd.
NCT04360122Phase 3May 20, 2020Ain Shams University
NCT04383717Phase 3May 5, 2020Cairo University
NCT04611373Phase 3May 1, 2020Zhengzhou University
NCT04331470Phase 2/Phase 3 (Phase 3)Apr 4, 2020Fasa University of Medical Sciences
NCT04049630Phase 2Jan 15, 2020Institut National de la Santé Et de la Recherche Médicale, France
NCT03950518Phase 3Apr 10, 2019Anyang Regional Hospital, Luoyang Central Hospital, Nanyang Central Hospital, Pingdingshan Coal Medical Group General Hospital, Sanmenxia Central Hospital, The Third People's Hospital of Jiaozuo, Zhengzhou University
NCT03940378Phase 3Feb 1, 2019Anyang Regional Hospital, Luoyang Central Hospital, Nanyang Central Hospital, pinmei Group General Hospital, Sanmenxia Central Hospital, The Third People's Hospital of Jiaozuo, Xinjiang Medical University, Zhengzhou University
NCT03218657N/AJan 1, 2018Zhejiang Chinese Medical University
NCT02818738Phase 3Jun 1, 2017University of Paris
NCT02203396Phase 2Aug 1, 2014Chinese Academy of Medical Sciences, Peking University
NCT01760096Phase 2Jan 1, 2013Chinese Academy of Medical Sciences
NCT01642979Phase 2Jul 1, 2012Chinese Academy of Medical Sciences
NCT01579110Phase 2Apr 1, 2012Chinese Academy of Medical Sciences
NCT02366884Phase 2Jul 1, 2011Dr. Frank Arguello Cancer Clinic, Instituto de Ciencia y Medicina Genomica
NCT01348321Phase 2/Phase 3 (Phase 3)Nov 1, 2008Ahvaz Jundishapur University of Medical Sciences, Jundishapur University of Medical Sciences
NCT00705692Phase 2Mar 1, 2008University of Tehran
NCT00659997Phase 4Jun 1, 2006Government of Tanzania, Natural History Museum, United Kingdom, University of London
NCT00002593Phase 3Dec 1, 1994Cancer and Leukemia Group B (CALGB), Eastern Cooperative Oncology Group, Harvard University, Mayo Clinic, National Cancer Institute (NCI), North Central Cancer Treatment Group, Rutgers University, Southwest Oncology Group, University of Pennsylvania
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (52)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Chinese Academy of Medical SciencesAcademic/Hospital4312012
National Cancer Institute (NCI)Government3011989
Zhengzhou UniversityAcademic/Hospital3312019
Anyang Regional HospitalAcademic/Hospital2012019
Cancer and Leukemia Group B (CALGB)Academic/Hospital2011994
Eastern Cooperative Oncology GroupAcademic/Hospital2011994
Harvard UniversityAcademic/Hospital2011994
Luoyang Central HospitalAcademic/Hospital2012019
Mayo ClinicAcademic/Hospital2011994
Nanyang Central HospitalAcademic/Hospital2012019
North Central Cancer Treatment GroupAcademic/Hospital2011994
Sanmenxia Central HospitalAcademic/Hospital2012019
Southwest Oncology GroupAcademic/Hospital2211994
The Third People's Hospital of JiaozuoAcademic/Hospital2012019
Ahvaz Jundishapur University of Medical SciencesAcademic/Hospital1112008
Ain Shams UniversityAcademic/Hospital1112020
Allegheny Health NetworkAcademic/Hospital1011989
Austrian Breast and Colorectal Cancer GroupAcademic/Hospital1111990
Cairo UniversityAcademic/Hospital1112020
Canadian Cancer Trials GroupAcademic/Hospital1011994
52 organizations
Page 1 / 3

Marketing (2)

OrganizationOrg typeRelationshipDate
Johnson and JohnsonFor profitNDA2Jun 18, 1990
Johnson and JohnsonFor profitNDAJun 18, 1990