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Piperaquine

Phase 1

Malaria | Small molecule | Infectious Disease |CNS Pharmaceuticals, Inc.|Last Updated: May 10, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Piperaquine · 1 trial · 1 indication

Phase 1 1
NCT03542149Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQPMalaria
COMPLETED24 Analytics
PHASE1COMPLETED
Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP
MalariaUnlock trial analytics

Study Endpoints

Primary Endpoints

Characterize the PK/PD Relationship Between OZ439 and PQP Plasma Concentrations (Cmax)
PK data up to Day 28 post-dose

Maximum observed drug concentration in observed individual concentration-time profile.

Characterize the PK/PD Relationship Between OZ439 and PQP and Blood Stage Asexual Parasitaemia Measured by Parasite Reduction Ratio at 48 Hours (PRR48)
From IP administration to 48 hours

Ratio between parasitemia at the onset of drug treatment and 48 hours later. The PRR is defined as the ratio of the number of parasites at time of treatment divided by the number after a given amount of time has elapsed post-treatment. This time period is normally 48 hours as this is the time taken for P. falciparum parasites to pass through their asexual erythrocytic life cycle.

Characterize the PK/PD Relationship Between OZ439 and PQP and Blood Stage Asexual Parasitaemia Measured by Parasite Clearance Half-life
from IP administration to 108 hours

PCt1/2 = Parasite Clearance Half-life;

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Cohort 1: Treatment Group A: 200mg of OZ439 and 480 mg PQPEXPERIMENTAL200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
Cohort 1:Treatment Group B: 200mg of OZ439 and 640 mg PQPEXPERIMENTAL200mg of OZ439 and 640 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
Cohort 1:Treatment Group C: 400mg of OZ439 and 480 mg PQPEXPERIMENTAL400mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
Cohort 1Treatment Group D and Cohort 3 Treatment group A : 400mg of OZ439 and 640 mg PQPEXPERIMENTAL400mg of OZ439 and 640 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
Cohort 2: Treatment Group A: 800mg of OZ439 and 960 mg PQPEXPERIMENTAL800mg of OZ439 and 960 mg PQP.
Cohort 2: Treatment Group B: 200mg of OZ439 and 320 mg PQPEXPERIMENTAL200mg of OZ439 and 320 mg PQP.
Cohort 3: Treatment Group B: 800mg of OZ439 and 640 mg PQPEXPERIMENTAL800mg of OZ439 and 640 mg PQP

Interventions

NameTypeDescription
480 mg Piperaquine phosphateDRUG480 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
640 mg Piperaquine phosphateDRUG640 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439DRUG200 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
400 mg OZ 439DRUG400 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
800 mg OZ 439DRUG800 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
960 mg PQPDRUG960 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
320 mg PQPDRUG320 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Adult (male and female) subjects between 18 and 55 years of age inclusive, who do not live alone (from inoculation day until at least the end of the Riamet® treatment) and will be contactable and available for the duration of the trial and contactable up to 2 weeks following ...

Countries:Australia
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Competitive Landscape -Malaria 6 trials

Frequently asked questions about Piperaquine

What is Piperaquine used for?

Piperaquine is an investigational small molecule being developed for the treatment of malaria. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and antimalarial activity in clinical trials.

Who makes Piperaquine?

Piperaquine is being developed by CNS Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol CNSP. The company is conducting clinical research on this small molecule for the treatment of malaria.

What phase is Piperaquine in?

Piperaquine is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for malaria.

What clinical trials is Piperaquine in?

Piperaquine has been studied in one completed Phase 1 clinical trial, identified as NCT03542149. This trial evaluated the safety, tolerability, and antimalarial activity of single doses of OZ439 and Piperaquine in healthy volunteers in Australia. The trial enrolled 24 participants.

Is Piperaquine the same as OZ439?

No, Piperaquine and OZ439 are distinct compounds. They were studied together in a clinical trial (NCT03542149) that evaluated the safety, tolerability, and antimalarial activity of single doses of both drugs. Piperaquine is being developed by CNS Pharmaceuticals, Inc.