One pill to beat worms? new drug emodepside takes on mebendazole
NCT ID NCT06736691
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a single dose of emodepside can cure soil-transmitted worm infections (like whipworm, hookworm, and roundworm) better than the standard 3-day course of mebendazole. About 315 adolescents and adults with confirmed infections will receive either emodepside or mebendazole, and researchers will check stool samples to see if the worms are gone. The goal is to find a simpler, more effective treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- emodepside
- What this could lead to
- If it works, this could offer a simpler, single-dose treatment for common worm infections, potentially improving cure rates and reducing the need for multiple doses.
- What could go wrong
- This is a single-center trial with 315 participants, so results may not apply broadly. Emodepside is new for this use, and side effects or lower-than-expected efficacy are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 315 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG). 3. A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline. 4. Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age. 5. Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit. Exclusion Criteria: 1. Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug. 2. Any of the following: 1. Platelet \<75,000/mm3 2. Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) \>3x upper limit of normal (ULN) 3. Total bilirubin \>2xULN 4. Estimated Glomerular Filtration Rate (eGFR) \<90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) \<90 ml/min (adults) 3. Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit. 4. Use of sensitive CYP3A4 substrates within 14 days before the start of the first study intervention and until at least 14 days after the last administration of study intervention (detailed list of prohibited medication is provided in Section 6.5.1). 5. Treatment with metronidazole within 2 days before the first dose of study intervention or planned before 24 hours after last administration of study intervention. 6. Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up). 7. Known allergy/hypersensitivity to mebendazole and/or emodepside
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Public Health Laboratory - Ivo de Carneri (PHL-IdC)
Chake Chake, Tanzania
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Other studies related to the condition(s) this trial covers.
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