Last reviewed · How we verify
Levamisol (LEVAMISOLE)
Levamisole is a small molecule drug in the levamisole class, originally developed by Janssen Pharmaceutica and currently owned by Johnson & Johnson. It targets the tissue-nonspecific isozyme of alkaline phosphatase and is FDA-approved for the treatment of Ancylostomiasis and Ascariasis. Levamisole is off-patent and has no active Orange Book patents, indicating that it is available as a generic medication. Despite its off-patent status, there are currently no generic manufacturers of levamisole. It has a bioavailability of 65%.
At a glance
| Generic name | LEVAMISOLE |
|---|---|
| Drug class | levamisole |
| Target | Alkaline phosphatase, tissue-nonspecific isozyme |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1990 |
Approved indications
- Ancylostomiasis
- Ascariasis
Common side effects
- Swelling at injection site
- Hypersalivation
- Tissue damage at injection site
Serious adverse events
- Granulomas at injection site
- Necrosis at injection site
- Clostridial infection
- Death
Drug interactions
- phenprocoumon
- warfarin
Key clinical trials
- Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT) (PHASE3)
- A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia (PHASE2)
- Dupilumab Therapy in Nephrotic Syndrome in Children (PHASE2)
- A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects (PHASE2,PHASE3)
- The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children (PHASE4)
- A Transdiagnostic Intervention for Health-related Habits (LEV) (NA)
- Pharmacological Modulation of Hippocampal Activity in Psychosis 2 (PHASE2)
- Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nephrotic Syndrome in Children (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Levamisol CI brief — competitive landscape report
- Levamisol updates RSS · CI watch RSS