Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cipargamin · 1 trial · 1 indication
A blood draw was performed at each collection time point for parasitemia assessment.
| Arm | Type | Description |
|---|---|---|
| IV Cipargamin 20 mg | EXPERIMENTAL | Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days). |
| IV Cipargamin 40 mg | EXPERIMENTAL | Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days). |
| IV Artesunate | ACTIVE_COMPARATOR | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
| Name | Type | Description |
|---|---|---|
| Cipargamin | DRUG | Cipargamin, 20 mg or 40 mg, by intravenous administration of solution for injection |
| IV Artesunate | DRUG | Artesunate, 2.4 mg/kg or 3 mg/kg, by intravenous administration of reconstituted solution |
| Coartem | DRUG | Oral standard of care (Coartem tablets, dosed per weight, as per label) |
Inclusion Criteria: * Cohort 1: Participants aged ≥ 12 years with moderately severe malaria as defined in (prostration and/or repeated vomiting) without presence of other signs of severe malaria (and with high P. falciparum parasitemia (60,000-250,000 parasites per µl) * Subsequent Cohorts 2 to ...
Cipargamin is an investigational small molecule being developed for severe malaria, specifically severe Plasmodium falciparum malaria. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Cipargamin is a small molecule that targets the Plasmodium falciparum parasite, the cause of severe malaria. It is designed to treat infections by this parasite, though its specific molecular target has not been disclosed in available information.
Cipargamin is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with severe malaria.
Cipargamin is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.
Cipargamin has been studied in one completed Phase 2 clinical trial with the identifier NCT04675931. This trial evaluated the efficacy, safety, tolerability, and pharmacokinetics of intravenous cipargamin in 254 participants with severe Plasmodium falciparum malaria across multiple African countries.
Cipargamin is not known to have alternative names. It is a distinct investigational compound developed by Novartis AG for the treatment of severe malaria, and no other names for this drug have been reported.