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INE963

Phase 2

Uncomplicated Plasmodium Falciparum Malaria | Small molecule | Infectious Disease |Novartis AG|Last Updated: Nov 19, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment379
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05750628Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum MalariaPHASE2 RECRUITING 327Jan 23, 2024Jun 23, 2026Jul 30, 202512 Burkina Faso, Côte d’Ivoire +4
NCT07235020Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum MalariaPHASE2 COMPLETED 52Jan 23, 2024Feb 21, 2025Nov 19, 20256 Burkina Faso, Côte d’Ivoire +4
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Study Endpoints
Primary Endpoints
Part A: parasite clearance time (PCT)
up to Day 7

Part A: To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.

Part B and C: polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)
Day 29

Part B and C: To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria. ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).

Parasite clearance time (PCT)
up to Day 7

To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.

Secondary Endpoints
Part A: PCR-corrected and uncorrected ACPR
Day 29
Parts B and C: PCT
up to Day 7
Parts B and C: PCR-uncorrected ACPR
Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A1: Dose Level 1 INE963EXPERIMENTALCohort A1: Dose Level 1 INE963
Cohort A1: Dose Level 2 INE963EXPERIMENTALCohort A1: Dose Level 2 INE963
Cohort A1: Dose Level 3 INE963EXPERIMENTALCohort A1: Dose Level 3 INE963
Cohort B1: Cipargamin + INE963EXPERIMENTALCohort B1: Cipargamin + INE963
Cohort B1: SoC (Coartem)ACTIVE_COMPARATORCohort B1: SoC (Coartem)
Cohort B2: Cipargamin + KLU156EXPERIMENTALCohort B2: Cipargamin + KLU156
Cohort B2: SoC (Coartem)ACTIVE_COMPARATORCohort B2: SoC (Coartem)
Cohort C2: Cipargamin + KLU156EXPERIMENTALCohort C2: Cipargamin + KLU156
Cohort C2: SoC (Coartem)ACTIVE_COMPARATORCohort C2: SoC (Coartem)
Cohort A1: Dose Level 4 INE963EXPERIMENTALCohort A1: Dose level 4 INE963
Cohort A1: INE963 Dose Level 1EXPERIMENTALCohort A1: INE963 Dose Level 1
Cohort A1: INE963 Dose Level 2EXPERIMENTALCohort A1: INE963 Dose Level 2
Cohort A1: INE963 Dose Level 3EXPERIMENTALCohort A1: INE963 Dose Level 3
Cohort A1: INE963 Dose Level 4EXPERIMENTALCohort A1: INE963 Dose Level 4
Interventions
NameTypeDescription
INE963DRUGoral INE963
KAE609 (Cipargamin)DRUGoral KAE609 (Cipargamin)
SoC (Coartem)DRUGSoC (Coartem)
KLU156DRUGoral sachet KLU156 (KAF156 + lumefantrine)
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Eligibility Criteria
Age Range2 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part B and 2 to \<12 years of age for Part C at screening. 2. Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150...

Countries:Burkina FasoCôte d’IvoireGabonGhanaKenyaUganda
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05750628primaryCompletionDate: changed
LOWMay 24, 2026NCT05750628studyFirstPostDate: changed