Biltricide

(Praziquantel)

ApprovedSmall molecule

Praziquantel is used to treat infections caused by parasitic worms, particularly schistosomiasis and tapeworm infections. It works by killing the parasites in the body.[2] Biltricide is currently approved and in use across 8 indications[4].[1]

Biltricide is one of 72 small molecule programs targeting Schistosomiasis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

SchistosomiasisCompleted

OpisthorchiasisActive, not recruiting

HelminthiasisActive, not recruiting

Urinary SchistosomiasisApproved

Intestinal SchistosomiasisApproved

MalariaActive, not recruiting

TreatmentCompleted

Disease ProgressionCompleted

SchistosomiasisApproved

Completed

OpisthorchiasisApproved

Active, not recruiting

HelminthiasisApproved

Active, not recruiting

Urinary SchistosomiasisApproved

Approved

Intestinal SchistosomiasisApproved

Approved

MalariaPreclinical

Active, not recruiting

TreatmentPreclinical

Completed

Disease ProgressionPreclinical

Completed

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Biltricide

Bayer

Approved

4 2

Dexilant

Takeda

Preclinical

2 3

Theo-Dur

Pfizer

Preclinical

1 4

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 5

Valium

Akero Therapeutics

Preclinical

2 6

Lotemax

PPharmos

Preclinical

1 7

Clomid

Ferring

Preclinical

1 8

Aurlumyn

BBTG International Inc.

Preclinical

1 9

Somavert

PPharmacia and Upjohn

Preclinical

1 10

Zoledronate

Mario Negri Institute for Pharmacological Research

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Treatment

NCT07074444

Clinical

Trials by Indication[1]

Schistosomiasis7 trials

Schistosomiasis Diagnosis Using a CAA Antigen Test

Unknown status·CCentre de Recherche Médicale de Lambaréné·Phase 3·NCT03779347·100 enrolled

Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

Completed·Ddsm-firmenich Switzerland AG·N/A·NCT02144389·335 enrolled

Effect of Schistosomiasis Mansoni on HIV Susceptibility and Female Genital Immunology

Completed·UUniversity of Toronto·Phase 4·NCT02878564·34 enrolled

Show 4 more trials

Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

Completed·DDafra Pharma·Phase 2/3·NCT00510159·800 enrolled

Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in People With Schistosomiasis

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT02734186

Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children

Completed·IInstitute of Tropical Medicine, Belgium·Phase 3·NCT03893097·726 enrolled

Prevention of Female Genital Schistosomiasis (FGS) in Rural High-endemic South Africa

Unknown status·OOslo University Hospital··NCT01154907·6,500 enrolled

Treatment4 trials

The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda

Completed·DDBL -Institute for Health Research and Development·N/A·NCT00215267·540 enrolled

A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni

Completed·KKenya Medical Research Institute·Phase 3·NCT01054651·212 enrolled

Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel

Recruiting·FFirst Affiliated Hospital of Guangxi Medical University·Phase 4·NCT07074444·318 enrolled

Show 1 more trial

Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique

Completed·DDBL -Institute for Health Research and Development·N/A·NCT00231322·520 enrolled

Children2 trials

Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren

Completed·UUniversiteit Antwerpen·Phase 3·NCT01722539·616 enrolled

Praziquantel in Children Under Age 4

Unknown status·RRhode Island Hospital·Phase 2·NCT03640377·600 enrolled

Morbidity1 trial

Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

Completed·MMakerere University·Phase 2·NCT01901484·800 enrolled

Infections1 trial

Schistosoma Haematobium Infections and Praziquantel

Completed·UUniversity of Khartoum·Phase 3·NCT01558336·520 enrolled

6 more indications

Disease Progression1 trial

Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression

Completed·UUniversity of Washington·N/A·NCT00507221·948 enrolled

AIN1 trial

Clinical Evaluation of Ujiplus® Against Schistosoma Mansoni

Completed·KKenya Medical Research Institute·Phase 2/3·NCT04679831·400 enrolled

Cysticercosis1 trial

Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ)

Completed·UUniversidad Peruana Cayetano Heredia·Phase 2/3·NCT00441285·156 enrolled

Pregnancy1 trial

S. Japonicum and Pregnancy Outcomes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00486863·370 enrolled

Malaria1 trial

Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children

Unknown status·LLondon School of Hygiene and Tropical Medicine·N/A·NCT05354258·600 enrolled

Unspecified2 trials

Praziquantel-Pharmacokinetic Study

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01288872·47 enrolled

Schistosoma Mansoni in Mwanza Region, Tanzania

Completed·DDBL -Institute for Health Research and Development·N/A·NCT02162875·37,500 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 29, 1982

BILTRICIDE

NDA NDA018714

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Praziquantel. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Biltricide drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Praziquantel compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Praziquantel. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018714). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Voltage-Activated Calcium Channel Beta 1 Subunit Blocker; Voltage-Activated Calcium Channel Beta 2 Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

Biltricide

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Schistosomiasis7 trials

Treatment4 trials

Children2 trials

Morbidity1 trial

Infections1 trial

Disease Progression1 trial

AIN1 trial

Cysticercosis1 trial

Pregnancy1 trial

Malaria1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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