levamisole
Trade name: ergamisol
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
Earliest trial started Jul 1, 1989 (NCT00425152)
Timeline
1980s
- Jan 1, 1989
Earliest Phase 3 Sponsor(trial)
1990s
- Jun 18, 1990
Johnson and Johnson — Earliest FDA Approval
- Jun 18, 1990
Johnson and Johnson — NDA Secondary Org
- Jun 18, 1990
Johnson and Johnson — NDA Organization
2000s
- Jan 1, 2008
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Studied for
- Acne Vulgaris · Phase 2/Phase 3
- Anemia · Phase 2
- Anemia, Aplastic · Phase 2
- Anemia, Hemolytic · Phase 2
- Anemia, Hemolytic, Autoimmune · Phase 2
- Ascariasis · Phase 4
- Autoimmune Diseases · Phase 2
- Bone Marrow Failure Disorders · Phase 2
- Carcinoma, Hepatocellular · Phase 3
- Catheters · Phase 3
- Colonic Neoplasms · Phase 3
- Colorectal Neoplasms · Phase 3
- COVID-19 · Phase 3
- Hematologic Diseases · Phase 2
- Hemoglobinuria · Phase 2
- Hemoglobinuria, Paroxysmal · Phase 2
- Hemolysis · Phase 2
- Immune System Diseases · Phase 2
- Kidney Diseases · Phase 4
- Loiasis · Phase 2/Phase 3
- Neoplasms · Phase 2
- Onchocerciasis, Ocular · Phase 2
- Pathologic Processes · Phase 2
- Proteinuria · Phase 2
- Renal Dialysis · Phase 2
- Respiratory Tract Infections · Phase 3
- Thrombosis · Phase 2
- Trichuriasis · Phase 4
- Urination Disorders · Phase 2
Mechanism of action
Nicotinic acetylcholine receptor alpha subunit agonist
Approval history
- approvedPriority reviewJun 18, 1990
Chemistry & pharmacology
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
- ChEMBLCHEMBL1454 ↗
- WikipediaLevamisole ↗
- NCATSDL9055K809 ↗
- ChEMBLCHEMBL554891 ↗
- ChEMBLCHEMBL277775 ↗
- ChEMBLCHEMBL1770 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06252961 | Phase 2/Phase 3 (Phase 3) | Jun 21, 2024 | Government of Congo, Government of France, Programme National de Lutte contre l'Onchocercose (PNLO) |
| NCT05772871 | Phase 4 | Apr 26, 2023 | Huazhong University of Science and Technology, LinkDoc Technology (Beijing) Co. Ltd. |
| NCT04360122 | Phase 3 | May 20, 2020 | Ain Shams University |
| NCT04383717 | Phase 3 | May 5, 2020 | Cairo University |
| NCT04611373 | Phase 3 | May 1, 2020 | Zhengzhou University |
| NCT04331470 | Phase 2/Phase 3 (Phase 3) | Apr 4, 2020 | Fasa University of Medical Sciences |
| NCT04049630 | Phase 2 | Jan 15, 2020 | Institut National de la Santé Et de la Recherche Médicale, France |
| NCT03950518 | Phase 3 | Apr 10, 2019 | Anyang 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 |
| NCT03940378 | Phase 3 | Feb 1, 2019 | Anyang 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 |
| NCT03218657 | N/A | Jan 1, 2018 | Zhejiang Chinese Medical University |
| NCT02818738 | Phase 3 | Jun 1, 2017 | University of Paris |
| NCT02203396 | Phase 2 | Aug 1, 2014 | Chinese Academy of Medical Sciences, Peking University |
| NCT01760096 | Phase 2 | Jan 1, 2013 | Chinese Academy of Medical Sciences |
| NCT01642979 | Phase 2 | Jul 1, 2012 | Chinese Academy of Medical Sciences |
| NCT01579110 | Phase 2 | Apr 1, 2012 | Chinese Academy of Medical Sciences |
| NCT02366884 | Phase 2 | Jul 1, 2011 | Dr. Frank Arguello Cancer Clinic, Instituto de Ciencia y Medicina Genomica |
| NCT01348321 | Phase 2/Phase 3 (Phase 3) | Nov 1, 2008 | Ahvaz Jundishapur University of Medical Sciences, Jundishapur University of Medical Sciences |
| NCT00705692 | Phase 2 | Mar 1, 2008 | University of Tehran |
| NCT00659997 | Phase 4 | Jun 1, 2006 | Government of Tanzania, Natural History Museum, United Kingdom, University of London |
| NCT00002593 | Phase 3 | Dec 1, 1994 | Cancer 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 |
Organizations
Research & Development (52)
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | NDA2 | Jun 18, 1990 |
| Johnson and Johnson | For profit | NDA | Jun 18, 1990 |