Albendazole
| Evidence Level: L2 | Predicted Indications: 3 |
Table of Contents
Albendazole: From Anthelmintic Therapy to Alveolar Echinococcosis
One-Sentence Summary
Albendazole is a benzimidazole anthelmintic (anti-worm drug) that is already marketed in the United States. The TxGNN model predicts it may be effective for alveolar echinococcosis, a severe liver parasitic disease. This is supported by 1 completed Phase 2 trial in the disease itself (n=194), 5 clinical trials in total and 20 publications, and albendazole is already the guideline-recommended parasitostatic treatment. The evidence therefore describes an established use more than a new discovery.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Evidence Pack (anthelmintic; approved indication text is not provided) |
| Predicted New Indication | Alveolar echinococcosis |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L2 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 12 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the Evidence Pack. Albendazole is a benzimidazole. In general pharmacology terms, it binds parasite beta-tubulin, blocks microtubule polymerization and glucose uptake, and reduces the viability of the larval stage (metacestode).
Alveolar echinococcosis is caused by the larval stage of Echinococcus multilocularis, a tapeworm. It mainly attacks the liver and looks like a slow-growing tumour. Surgery is the only potentially curative option, but many patients are diagnosed too late for it. The published reviews and the expert consensus describe benzimidazoles, mainly albendazole, as the backbone of drug treatment.
Albendazole is parasitostatic, not curative. It slows parasite growth but does not kill it, so the parasite can resume growth when treatment stops. This is why the literature calls for better options, and why albendazole is best viewed as an established therapy rather than a new one.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07182305 | Phase 2 | Completed | 194 | Albendazole treatment in early-stage alveolar echinococcosis found by ultrasound screening in Kyrgyzstan; the most direct evidence. No results in the pack. |
| NCT02876146 | N/A | Completed | 50 | EchinoVISTA prospective study: markers of parasite viability to guide follow-up and timing of albendazole withdrawal. Supports monitoring, not efficacy. |
| NCT06483880 | N/A | Unknown | 24 | Randomised trial of adjuvant albendazole vs placebo after pulmonary hydatid cyst resection. Mainly cystic disease; small. |
| NCT05824442 | N/A | Recruiting | 43 | Multiplex qPCR for diagnosing echinococcosis. Diagnostic study with no therapeutic evidence. |
| NCT07176598 | N/A | Completed | 1 | Case report of an intramuscular hydatid cyst. Not alveolar disease; no efficacy inference. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 19931502 | 2010 | Guideline/Consensus | Acta Trop | Expert consensus on diagnosis, treatment and follow-up of cystic and alveolar echinococcosis |
| 39311470 | 2024 | Review | Parasite | Benzimidazoles are the only recommended drugs but are parasitostatic and can cause liver dysfunction |
| 39606163 | 2024 | Review | World J Hepatol | Current status of drug therapy; surgery is primary, drugs are for patients who cannot have surgery |
| 36974024 | 2022 | Review | Chin J Schisto Control | Albendazole may delay disease progression in patients who cannot or will not have surgery |
| 34161992 | 2021 | Review | Semin Liver Dis | Overview of hepatic alveolar echinococcosis, a rare, severe zoonosis with a growing number of cases |
| 39254012 | 2024 | Review | Tidsskr Nor Laegeforen | Treatment is often extensive surgical resection combined with prolonged drug therapy |
| 30760475 | 2019 | Review | Clin Microbiol Rev | 21st-century advances in diagnosis and treatment of echinococcosis |
| 34808118 | 2022 | Review | Acta Trop | No non-surgical option yet replaces albendazole or mebendazole |
| 38501660 | 2024 | Preclinical (rat model) | Antimicrob Agents Chemother | Solubilizing formulations developed to overcome albendazole’s poor oral bioavailability |
| 34688631 | 2022 | Preclinical | Acta Trop | Carvacrol plus albendazole was more effective than albendazole alone in experimental disease |
No randomised controlled trial of albendazole in alveolar echinococcosis appears in the supplied literature.
US Market Information
12 US authorizations are on record; the 5 main ones are listed. Approved indication text is not provided in the Evidence Pack.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| NDA020666 | ALBENZA | Film-coated tablet | Amneal Pharmaceuticals LLC |
| NDA020666 | Albendazole | Film-coated tablet | Amneal Pharmaceuticals of New York LLC |
| ANDA215652 | Albendazole | Film-coated tablet | Alembic Pharmaceuticals Inc. |
| ANDA211034 | Albendazole | Film-coated tablet | Dr. Reddy’s Laboratories Inc |
| ANDA213435 | Albendazole | Tablet | Bryant Ranch Prepack |
All listed forms are oral.
Safety Considerations
- Drug Interactions: No interaction records were found in the queried source.
- Literature notes: Reviews mention that benzimidazoles can cause liver dysfunction and, in some patients, severe adverse effects. This matters because alveolar echinococcosis treatment is long-term.
Warnings and contraindications are not available in the Evidence Pack. Please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: A completed Phase 2 trial in early-stage alveolar echinococcosis, a consensus guideline and multiple reviews support albendazole as the established drug therapy. Because it is only parasitostatic, and long-term use carries liver-safety concerns, it should be handled as a supportive or adjunct therapy alongside surgery where possible, not as a cure.
To proceed, the following is needed:
- Package insert warnings and contraindications (a blocking safety gap)
- Published results of NCT07182305, including its efficacy endpoints
- Mechanism of action data from DrugBank
- A long-term liver function monitoring plan for prolonged treatment
- Confirmation of the original approved indication text, which is missing from the US license records
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.