Overview
Levamisole is an antihelminthic drug that was commonly used for the treatment of parasitic, viral, and bacterial infections. It was manufactured by Janssen and first used in 1969 as an agent to treat worm infestations Levamisole was approved by the FDA in 1990 as an adjuvant treatment for colon cancer. Prior to this, levamisole was used as an antirheumatic therapy in the 1970s and 1980s for patients with rheumatoid arthritis. Because of its immunomodulatory effects, this drug has been studied in the treatment of various immune-mediated diseases, with some studies showing positive results. This drug has also been used in combination with other drugs for the treatment of various cancers. Levamisole was withdrawn from the American market in 2000 due to its ability to cause serious adverse effects, including agranulocytosis. Interestingly, levamisole has been found as an adulterant in cocaine and can lead to a variety of adverse effects in individuals using this drug.
Indication
For adjuvant treatment in combination with fluorouracil after surgical resection in patients with Dukes' stage C colon cancer. Also used to treat malignant melanoma and head/neck cancer.
Associated Conditions
- Adenocarcinoma of Colon
- Ancylostoma duodenale infection
- Ascaris lumbricoides infection
- Colorectal Carcinoma (CRC)
- Enterobius vermicularis infection
- Necatoriasis due to necator americanus
- Strongyloides Stercoralis Infection
- Trichuris Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/12 | Phase 2 | Not yet recruiting | Programme National de Lutte contre l'Onchocercose, Republic of the Congo | ||
2023/03/16 | Phase 4 | Recruiting | Jianhua Zhou | ||
2020/05/12 | Phase 3 | UNKNOWN | |||
2020/04/24 | Phase 3 | UNKNOWN | |||
2020/04/02 | Phase 2 | UNKNOWN | Fasa University of Medical Sciences | ||
2019/05/15 | Phase 3 | UNKNOWN | The First Affiliated Hospital of Zhengzhou University | ||
2019/05/07 | Phase 3 | UNKNOWN | The First Affiliated Hospital of Zhengzhou University | ||
2017/07/14 | Not Applicable | UNKNOWN | Shengyun Lin | ||
2016/06/30 | Phase 3 | Completed | |||
2012/04/17 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zoetis Inc. | 54771-1685 | SUBCUTANEOUS | 150 mg in 1 mL | 3/24/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Levamisole Hydrochloride Pills | 国药准字H21022832 | 化学药品 | 丸剂 | 6/19/2020 | |
| Levamisole Hydrochloride Pills | 国药准字H21024199 | 化学药品 | 丸剂 | 7/23/2020 | |
| Levamisole Hydrochloride Granules | 国药准字H20059935 | 化学药品 | 颗粒剂 | 6/19/2020 | |
| Levamisole Hydrochloride Granules | 国药准字H12020340 | 化学药品 | 颗粒剂 | 8/6/2020 | |
| Levamisole Hydrochloride Granules | 国药准字H22020187 | 化学药品 | 颗粒剂 | 2/19/2020 | |
| Levamisole Hydrochloride Granules | 国药准字H51020395 | 化学药品 | 颗粒剂 | 3/3/2021 | |
| Levamisole Hydrochloride Suppositories | 国药准字H23021966 | 化学药品 | 栓剂 | 6/29/2020 | |
| Levamisole Hydrochloride Suppositories | 国药准字H11021446 | 化学药品 | 栓剂 | 12/8/2020 | |
| Levamisole Hydrochloride Suppositories | 国药准字H14020255 | 化学药品 | 栓剂 | 8/6/2020 | |
| Levamisole Hydrochloride Suppositories | 国药准字H23022466 | 化学药品 | 栓剂 | 6/29/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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