Albenza

(Albendazole)

Phase 3Small molecule

IImpax Laboratories, LLC

Albenza is one of 15 small molecule programs targeting Onchocerciasis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

OnchocerciasisActive, not recruiting

Double-BlindNot yet recruiting

OnchocerciasisPreclinical

Active, not recruiting

Double-BlindPhase 3

Not yet recruiting

Competition

Competitive Landscape

10 competitors in Double-Blind

#DrugCompanyPhaseTrials

Olumiant

Eli Lilly

Phase 3

1 2

Albenza

IImpax Laboratories, LLC

Phase 3

1 3

Everolimus and Lonafarnib

BBoston Children's Hospital

Phase 3

1 4

Inosine Pranobex

NNewport Pharmaceuticals International

Preclinical

2 5

PORT-77

PPortal Therapeutics, Inc.

Phase 1

1 6

Western Therapy

JJiangxi Qingfeng Pharmaceutical Co. Ltd.

Preclinical

1 7

Interferon Alfa-N3

IInterferon Sciences

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Not yet recruiting

Trichuris Infection

NCT07258173

Q2 2027

Phase 2Recruiting

Trichuriasis

NCT04713787

Phase 3Not yet recruiting

Trichuriasis

NCT07661316

Q4 2027

PreclinicalRecruiting

Onchocerciasis

NCT07707817

Phase 3Not yet recruiting

Double-Blind

NCT06613997

Clinical

Trials by Indication[1]

Efficacy and Safety5 trials

Efficacy and Safety of IVM/ALB Co-administration

Completed·JJennifer Keiser·Phase 2/3·NCT03527732·1,673 enrolled

Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

Completed·JJennifer Keiser·Phase 2·NCT05538767·320 enrolled

Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration

Completed·JJennifer Keiser·Phase 2/3·NCT04700423·536 enrolled

Show 2 more trials

Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC

Completed·JJennifer Keiser·Phase 3·NCT06188715·224 enrolled

Efficacy and Safety of MOX/ALB Co-administration

Completed·JJennifer Keiser·Phase 3·NCT04726969·255 enrolled

Onchocerciasis2 trials

Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis

Completed·WWashington University School of Medicine··NCT01905423·17,108 enrolled

A Community Mapping and Participatory Research Protocol for Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations Through Social and Occupational Networks in Nigeria: MISSION Nigeria

Recruiting·UUwemedimo Friday Ekpo·Preclinical·NCT07707817·5,760 enrolled

Trichuriasis2 trials

A Phase 2, Partially-Blinded, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole for the Treatment of Trichuris Trichiura Infection in Adults

Recruiting·AAsociacion Benefica Prisma·Phase 2·NCT04713787·249 enrolled

Randomized, Open-Label, Assessor-Blinded Clinical Trial of Combination Therapies Versus Standard Treatment for Trichuris Trichiura Infection in Schoolchildren in La Moskitia, Honduras

Not yet recruiting·MMundo Sano Foundation·Phase 3·NCT07661316·368 enrolled

MPA1 trial

Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

Completed·CCentre d'Appui à la lutte contre la Maladie·Phase 4·NCT02784743·1,139 enrolled

Efficacy1 trial

Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi

Terminated·LLondon School of Hygiene and Tropical Medicine·N/A·NCT01213576·70 enrolled

6 more indications

GAN1 trial

Co-administration of IVM and ALB in School-based Deworming in Uganda

Completed·JJennifer Keiser··NCT06497075·8,767 enrolled

Double-blind1 trial

21-day Double-blind Trial of Albendazole in Adults With Loa Loa Microfilaremia

Not yet recruiting·PProgramme National de Lutte contre l'Onchocercose, Republic of the Congo·Phase 3·NCT06613997·100 enrolled

Infections1 trial

The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia

Completed·UUniversity Ghent·Phase 4·NCT01327469·2,250 enrolled

Acceptability1 trial

Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC

Completed·JJennifer Keiser·Phase 2·NCT06184399·260 enrolled

Adult1 trial

Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions

Completed· GSK logo

GSK·Phase 1·NCT06201559·70 enrolled

Trichuris Infection1 trial

Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita: a Phase II, Randomized, Double Blind, Controlled Trial

Not yet recruiting·JJennifer Keiser·Phase 2·NCT07258173·100 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 11, 1996

ALBENZA

NDA NDA020666

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Albendazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Albendazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Albendazole. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020666). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Impax Laboratories, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: IImpax Laboratories, LLC

Albenza

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Efficacy and Safety5 trials

Onchocerciasis2 trials

Trichuriasis2 trials

MPA1 trial

Efficacy1 trial

GAN1 trial

Double-blind1 trial

Infections1 trial

Acceptability1 trial

Adult1 trial

Trichuris Infection1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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