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Also known as emodepside (BAY 44-4400)
emodepside · 2 trials · 3 indications
Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit
| Arm | Type | Description |
|---|---|---|
| Emodepside | EXPERIMENTAL | - |
| Mebendazole | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| emodepside (BAY 44-4400) | DRUG | Treatment with single dose of oral 15 mg emodepside |
| Mebendazole 100 MG | DRUG | Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days |
| similar placebo to mebendazole | DRUG | Treatment with mebendazole similar placebo orally administered b.i.d. for 3 days |
| matching placebo of emodepside | DRUG | Treatment with single dose of oral emodepside matching placebo |
| Mebendazole | DRUG | Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days |
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...
Emodepside is being developed for the treatment of soil-transmitted helminth infections, including Trichuris trichiura (whipworm), hookworm infection, and Ascaris lumbricoides (roundworm) infection. It is an investigational small molecule in Phase 3 clinical development and is not yet approved for these infections.
Emodepside is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is running the Phase 3 clinical program evaluating the drug in participants with soil-transmitted helminth infections across multiple countries.
Emodepside is in Phase 3 clinical development. Two Phase 3 trials are ongoing, one active and not recruiting and one not yet recruiting, with a combined planned enrollment of 630 participants. The drug is investigational and has not been approved for any indication.
Emodepside is being studied in two Phase 3 trials: NCT06800248, which is not yet recruiting in the Philippines, and NCT06736691, which is active and not recruiting in Tanzania. Both trials enroll participants aged 12 years and older with soil-transmitted helminth infections and each plans to enroll 315 participants.
Yes, emodepside is also known as BAY 44-4400. Both names refer to the same investigational small molecule developed by Bayer AG for soil-transmitted helminth infections, including Trichuris trichiura, hookworm, and Ascaris lumbricoides infections.
Both Phase 3 trials of emodepside are randomized, double-blind, and active-controlled, enrolling 315 participants each. They include participants aged 12 years and older with Trichuris trichiura, hookworm, or Ascaris lumbricoides infection, and neither trial selects patients by biomarker.