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emodepside

Phase 3

Trichuris Trichiura; Infection | Small molecule | Other |Bayer AG|Last Updated: Jun 11, 2026

Target and mechanism

ModalitySmall molecule

Also known as emodepside (BAY 44-4400)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment315

FDA Designations

No designations recorded

Clinical trial landscape

emodepside · 1 trial · 3 indications

Phase 3 1
NCT06800248Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth InfectionsTrichuris Trichiura; Infection
NOT YET_RECRUITING315 Analytics
PHASE3NOT YET_RECRUITING
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Trichuris Trichiura; InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Cured of T. trichiura infection
Test of Cure Visit at 14 to 21 days after end of treatment

Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit

Secondary Endpoints

Cured of A. lumbricoides infection
Time Frame: Test of Cure Visit at 14 to 21 days after end of treatment
Occurrence of TEAEs
Adverse events that occur after the first dose of study intervention up to 21 days after the last dose of study intervention
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EmodepsideEXPERIMENTAL -
MebendazoleACTIVE_COMPARATOR -

Interventions

NameTypeDescription
emodepside (BAY 44-4400)DRUGTreatment with single dose of oral 15 mg emodepside
Mebendazole 100 MGDRUGTreatment with 100 mg mebendazole orally administered b.i.d. for 3 days
similar placebo to mebendazoleDRUGTreatment with mebendazole similar placebo orally administered b.i.d. for 3 days
matching placebo of emodepsideDRUGTreatment with single dose of oral emodepside matching placebo
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older. 2. T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assess...

Countries:Philippines
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Frequently asked questions about emodepside

What is emodepside used for?

Emodepside is an investigational small molecule being developed for the treatment of Trichuris trichiura infection, also known as whipworm infection. It is currently in Phase 3 clinical development and is being studied in patients with soil-transmitted helminth infections, including hookworm and Ascaris lumbricoides infections.

Who makes emodepside?

Emodepside is being developed by Bayer AG, a German pharmaceutical company. The company's stock is traded over-the-counter under the ticker symbol BAYRY.

What phase is emodepside in?

Emodepside is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to evaluate its efficacy and safety in participants with soil-transmitted helminth infections.

What clinical trials is emodepside in?

Emodepside is being studied in a Phase 3 clinical trial with the identifier NCT06800248. This randomized, double-blind, active-controlled trial is expected to enroll 315 participants aged 12 years and older in the Philippines. The study is not yet recruiting and will evaluate the drug's efficacy and safety in treating Trichuris trichiura, hookworm, and Ascaris lumbricoides infections.

Is emodepside the same as BAY 44-4400?

Yes, emodepside is also known as BAY 44-4400. Both names refer to the same investigational drug being developed by Bayer AG for the treatment of soil-transmitted helminth infections.