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MAGNE-B6

Phase 1

Healthy Volunteers | Small molecule | Other |Sanofi|Last Updated: Sep 12, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

MAGNE-B6 · 1 trial · 1 indication

Phase 1 1
NCT06386211Bioavailability Study of Magne-B6 New FormulationHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
Bioavailability Study of Magne-B6 New Formulation
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Study Endpoints

Primary Endpoints

Maximal Observed Concentration (Cmax) of Magnesium in Plasma
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2
Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine
Pre-dose and Days 1 and 2 after the treatment administration in Period 1 and 2

Secondary Endpoints

Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
From screening up to 3 days after last administration (approximately 7 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Sequence Group 1EXPERIMENTAL -
Treatment Sequence Group 2EXPERIMENTAL -

Interventions

NameTypeDescription
MAGNE-B6 Oral SolutionDRUGOral solution.
MAGNE-B6 New Formulation TabletDRUGNew formulation tablet.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female participants, between 18 and 45 years of age, inclusive. 2. Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m\^2), inclusive...

Countries:Turkey (Türkiye)
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Frequently asked questions about MAGNE-B6

What is MAGNE-B6 used for?

MAGNE-B6 is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess the bioavailability of a new formulation. The drug is not approved and remains in clinical development.

Who makes MAGNE-B6?

MAGNE-B6 is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical research on this investigational drug, which is currently in Phase 1 development.

What phase is MAGNE-B6 in?

MAGNE-B6 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its bioavailability.

What clinical trials is MAGNE-B6 in?

MAGNE-B6 has one completed Phase 1 clinical trial, identified as NCT06386211. This study, titled 'Bioavailability Study of Magne-B6 New Formulation,' enrolled 24 healthy volunteers in Turkey and was a controlled, randomized trial.

Is MAGNE-B6 FDA approved?

MAGNE-B6 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in healthy volunteers to assess the bioavailability of a new formulation, and it has not completed the clinical trial process.