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New Worm-Fighting pill could help millions of children

NCT ID NCT06128447

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This phase 3 trial tests a chewable tablet called ZP5-9676 (flubendazole) against common intestinal worms like hookworm, roundworm, and whipworm. About 300 people aged 6 months to 59 years from high-risk areas will receive either the drug or a placebo. The goal is to see if the drug can cure the infection and reduce egg counts in stool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZP5-9676 (flubendazole) chewable tablet
What this could lead to
If successful, this could provide a new, effective treatment for common intestinal worm infections, improving health in affected communities.
What could go wrong
This is a placebo-controlled trial, so some participants may not receive active treatment. Results may vary by worm type, and long-term effectiveness is not yet known.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 59 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provide a signed informed consent form from the participant or parent/guardian, and assent by participant(as applicable per local requirements) and understand and agree to comply with required procedures in the study. 2. Male or female, who are 6 months to 59 years old, inclusive, and live in a high STH prevalence area 3. Positive for hookworm (A. duodenale or N. americanus), A. lumbricoides, and/or T. trichiura on microscopic examination of fecal samples. 4. Females of childbearing potential must use an acceptable method of contraception as determined by the Investigator from the initial Screening visit through 35 days after study drug administration. A female is considered to be of childbearing potential from menarche until after menopause (age \>45 years with no menses for 12 months without an alternative medical cause) unless permanently sterile. Acceptable methods include abstinence, hormonal contraceptives, intrauterine device/system, vasectomy in the sole male sexual partner, tubal ligation, or double-barrier contraceptive method (male condom with female cervical cap, diaphragm, or sponge) with spermicide. 5. Otherwise healthy based on medical history, physical examination, vital signs, and concomitant medications for inclusion. Exclusion Criteria: 1. Severe anemia (hemoglobin\< 8 g/dL1). 2. Active diarrhea (passage of ≥3 loose or liquid stools per day). 3. Children (6 months to 17 years old) with significant wasting (moderate and severe-below minus two standard deviations from median weight for height of reference population). 4. Women who are pregnant. 5. Hypersensitivity or allergy to ZP5-9676 or any inert ingredients in the chewable formulation or other medications in the benzimidazole class. 6. Taken ZP5-9676 or any other treatment for STH infection within 30 days of screening or randomization. 7. Used an investigational medical device within 30 days of screening. 8. Preplanned surgery procedures within 30 days of screening. 9. History of a medical disorder causing difficulty in chewing or swallowing. 10. Participation in any investigational drug (including vaccine) trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the start of the study (time of first dose). 11. Participation in an interventional clinical study within 30 days of screening. 12. Any condition that interferes with the ability to understand or comply with the requirements of the study. 13. Any other medical condition, serious illness, or other circumstance that would place the subject at increased risk, as determined by the Investigator

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clínica de Vacinas

    RECRUITING

    Americaninha, Brazil