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KLU156 · 1 trial · 1 indication
To confirm the efficacy of KLU156 in adults and children ≥ 10 kg of body weight suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. co-infection) by demonstrating that KLU156 is non-inferior to Coartem (non-inferiority margin = 5%) based on the PCR-corrected ACPR at Day 29. This primary outcome is applicable to non-US submission.
To further confirm the efficacy of KLU156 by demonstrating non-inferiority of KLU156 to Coartem (NI margin 7.5%) based on the uncorrected ACPR at Day 29. This primary outcome is applicable to US New Drug Application (NDA) submission.
| Arm | Type | Description |
|---|---|---|
| KLU156 | EXPERIMENTAL | KLU156 once daily (QD) for 3 days under fed conditions (light meal). |
| Coartem | ACTIVE_COMPARATOR | Coartem twice a day (BID) for 3 days under fed conditions. |
| Name | Type | Description |
|---|---|---|
| KLU156 | DRUG | Oral use. KLU156 (400/480 mg) is the dose for patients with a bodyweight ≥ 35kg. Patients \< 35kg will take a fraction of the dose according to weight group as defined in the protocol. |
| Coartem | DRUG | Oral use. Dosing will be selected based on patient's body weight as per product's label. |
Key Inclusion criteria (Core phase) 1. Male or female patients ≥ 10 kg of body weight. 2. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia ≥ 1,000 and ≤ 200,000 parasites/µL at the time of pre-screening with or without other Plasmo...
KLU156 is an investigational small molecule being developed for the treatment of uncomplicated Plasmodium falciparum malaria. It is intended for use in adults and children, including those as young as two months old. The drug is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.
KLU156 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the efficacy, safety, and tolerability of KLU156 in patients with uncomplicated Plasmodium falciparum malaria.
KLU156 is in Phase 3 clinical development. A Phase 3 trial has been completed, involving 1,720 participants. The drug is still investigational and has not received regulatory approval. It is being studied for the treatment of uncomplicated Plasmodium falciparum malaria in adults and children.
KLU156 has one completed Phase 3 clinical trial registered as NCT05842954, titled "Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria." The trial enrolled 1,720 participants across multiple African countries, including Burkina Faso, Ghana, Kenya, and Uganda.
KLU156 is a small molecule designed to treat uncomplicated Plasmodium falciparum malaria. Its specific molecular target has not been disclosed in available information. The drug is being evaluated in a randomized, active-controlled Phase 3 trial to assess its efficacy, safety, and tolerability compared to an existing treatment.
No alternative names for KLU156 have been disclosed in available information. The drug is identified solely by its code name KLU156 in clinical trial registrations and development records. It is an investigational compound and is not known to be marketed under any other brand name.