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 7 indications[4].[1]

Biltricide is one of 44 small molecule programs targeting Cysticercosis. 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

CysticercosisActive, not recruiting

SchistosomiasisActive, not recruiting

HelminthiasisActive, not recruiting

MalariaActive, not recruiting

Intestinal SchistosomiasisApproved

Urinary SchistosomiasisApproved

OpisthorchiasisActive, not recruiting

CysticercosisPhase 2

Active, not recruiting

SchistosomiasisApproved

Active, not recruiting

HelminthiasisApproved

Active, not recruiting

MalariaPreclinical

Active, not recruiting

Intestinal SchistosomiasisApproved

Approved

Urinary SchistosomiasisApproved

Approved

OpisthorchiasisApproved

Active, not recruiting

Competition

Competitive Landscape

479 competitors in Malaria

#DrugCompanyPhaseTrials

Biltricide

Bayer

Approved

1 2

Stelara

Johnson & Johnson

Preclinical

—3

Hydroxychloroquine Sulfate

Novartis

Preclinical

—4

Iron

WWatson Pharmaceuticals

Preclinical

1 5

IV LBH589

Novartis

Preclinical

1 6

Mefloquine Plus Artesunate

Medicines for Malaria Venture

Preclinical

1 7

IV Ceftriaxone

RRESnTEC, Institute of Research

Preclinical

1 8

RTS,S/AS01E

GSK

Preclinical

4 9

Piperaquine

UUniversity of Oxford

Preclinical

3 10

Malarone

Medicines for Malaria Venture

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

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

Effect of Schistosomiasis Mansoni on HIV Susceptibility and Female Genital Immunology

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

Schistosomiasis Diagnosis Using a CAA Antigen Test

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

Show 4 more trials

Arachidonic Acid Treatment Against Schistosomiasis Infection in Children

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

Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

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

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

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

Treatment4 trials

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

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

Show 1 more trial

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

Children2 trials

Praziquantel in Children Under Age 4

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

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

Completed·UUniversiteit Antwerpen·Phase 3·NCT01722539·616 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

Infections1 trial

Schistosoma Haematobium Infections and Praziquantel

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

6 more indications

Cysticercosis1 trial

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

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

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

Pregnancy1 trial

S. Japonicum and Pregnancy Outcomes

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

Morbidity1 trial

Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

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

Unspecified2 trials

Schistosoma Mansoni in Mwanza Region, Tanzania

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

Praziquantel-Pharmacokinetic Study

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

Malaria1 trial

Infections1 trial

Cysticercosis1 trial

Disease Progression1 trial

AIN1 trial

Pregnancy1 trial

Morbidity1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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