cipargamin intravenous (KAE609 IV) / Novartis - LARVOL DELTA

To evaluate efficacy, safety, tolerability and PK of intravenous cipargamin in participants with severe Plasmodium falciparum (clinicaltrialsregister.eu) - P2 | N=254 | Sponsor: Novartis Pharma AG

New P2 trial • Infectious Disease • Malaria • Pediatrics

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=254 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Malaria • Pediatrics

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=254 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Malaria • Pediatrics

The non-artemisinin antimalarial drugs under development: a review. (PubMed, Clin Microbiol Infect) - "Although attrition remains a possibility, several promising candidate drugs with novel modes of action are advancing through clinical development. Many are expected to become available for treating uncomplicated and severe malaria within the next decade. These new antimalarials could significantly enhance malaria treatment, reduce resistance, and support global health effort toward malaria control, elimination, and, potentially, eradication."

Journal • Review • Infectious Disease • Malaria

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=252 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2025 ➔ Sep 2025 | Trial primary completion date: May 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Infectious Disease • Malaria • Pediatrics

First-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending doses clinical study to assess the safety, tolerability, and pharmacokinetics of cipargamin administered intravenously in healthy adults. (PubMed, Antimicrob Agents Chemother) - P1 | "This first-in-human study assessed safety, tolerability, and pharmacokinetics (PK) of cipargamin (intravenous) in healthy adults. However, these results should be interpreted with caution due to inadequate Fridericia's QT correction. This study is registered with ClinicalTrials.gov as NCT04321252."

Clinical • Journal • P1 data • PK/PD data • Gastrointestinal Disorder • Infectious Disease • Malaria

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=252 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Feb 2024 ➔ May 2025 | Trial primary completion date: Feb 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Infectious Disease • Malaria • Pediatrics

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=252 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria • Pediatrics

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2; N=252; Not yet recruiting; Sponsor: Novartis Pharmaceuticals; Initiation date: Aug 2021 ➔ Nov 2021

Trial initiation date • Infectious Disease • Malaria • Pediatrics

Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects (clinicaltrials.gov) - P1; N=57; Completed; Sponsor: Novartis Pharmaceuticals; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Malaria

To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2; N=252; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

Clinical • New P2 trial • Infectious Disease • Malaria • Pediatrics

Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Malaria

Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Novartis Pharmaceuticals; Initiation date: Apr 2020 ➔ Jul 2020

Clinical • Trial initiation date • Infectious Disease • Malaria

Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

Clinical • New P1 trial