KAE609: Clinical Trials

8 completed, 1 recruiting, 1 terminated. 8 Phase 2, 2 Phase 1.

By phase and status

Phase	Trials	Status
Phase 2	8	Completed 7, Recruiting 1
Phase 1	2	Completed 1, Terminated 1

Follow KAE609: new trials by email Literature Review of KAE609 trials Research Report on KAE609

Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2) KAE609, SoC (Coartem), KLU156 - Uncomplicated Plasmodium Falciparum Malaria	Phase 2	Recruiting	Novartis Pharmaceuticals	120	2026-02-12	2026-10-15
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B1) KAE609 (Cipargamin), SoC (Coartem), INE963 - Uncomplicated Plasmodium Falciparum Malaria	Phase 2	Completed	Novartis Pharmaceuticals	95	2025-10-10	2026-09-10
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2) KAE609, SoC (Coartem), KLU156 - Uncomplicated Plasmodium Falciparum Malaria	Phase 2	Completed	Novartis Pharmaceuticals	60	2024-01-23	2026-05-07
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria Cipargamin, IV Artesunate, Coartem - Severe Malaria	Phase 2	Completed	Novartis Pharmaceuticals	254	2022-03-07	2026-04-09
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects KAE609, Placebo - Malaria	Phase 1	Completed	Novartis Pharmaceuticals	57	2020-07-22	2021-12-13
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria. KAE609, Coartem - Malaria	Phase 2	Completed	Novartis Pharmaceuticals	188	2017-11-16	2021-10-11
Effectiveness of KAE609 in Reducing Asexual & Sexual Blood-stage P.Falciparum Infection & Infectivity to Mosquitos KAE609, Piperaquine Phosphate - Plasmodium Falciparum Malaria	Phase 1	Terminated	Novartis Pharmaceuticals	8	2015-07-01	2019-07-23
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection KAE609 - Malaria	Phase 2	Completed	Novartis Pharmaceuticals	25	2014-01-01	2016-10-31
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection KAE609 - Cure Rate	Phase 2	Completed	Novartis Pharmaceuticals	11	2013-07-01	2015-09-10
Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection KAE609 - Malaria	Phase 2	Completed	Novartis Pharmaceuticals	27	2012-01-01	2013-05-13

Conditions studied

Malaria (6)  ·  Malaria, Falciparum (4)  ·  Acute malaria (1)  ·  Parasitemia (1)

Sponsors

Novartis Pharmaceuticals (10)

Countries

Côte d’Ivoire (4)  ·  Gabon (4)  ·  Kenya (4)  ·  Rwanda (4)  ·  Uganda (4)  ·  Burkina Faso (3)  ·  Ghana (3)  ·  Thailand (2)  ·  Vietnam (2)  ·  Australia (1)  ·  Belgium (1)  ·  Democratic Republic of the Congo (1)  ·  Mali (1)  ·  Mozambique (1)

Top investigators

James McCarthy, MD FRACP (1)

Results publications

PMID 25075833, PMID 27872070, PMID 33199389, PMID 34410358, PMID 34930267, PMID 39058022

NIH funding

2019 (1)