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BF2.649 add on Modafinil

Bioprojet · Phase 3 active Small molecule

BF2.649 is a histamine H3 receptor antagonist that enhances wakefulness and cognitive function when combined with modafinil's dopamine/norepinephrine reuptake inhibition.

BF2.649 is a histamine H3 receptor antagonist that enhances wakefulness and cognitive function when combined with modafinil's dopamine/norepinephrine reuptake inhibition. Used for Excessive daytime sleepiness in narcolepsy (as add-on to modafinil), Cognitive impairment and fatigue in neurological conditions.

At a glance

Generic nameBF2.649 add on Modafinil
Also known asPitolisant, Modiodal
SponsorBioprojet
Drug classHistamine H3 receptor antagonist
TargetHistamine H3 receptor (H3R)
ModalitySmall molecule
Therapeutic areaNeurology / Sleep Medicine
PhasePhase 3

Mechanism of action

BF2.649 blocks histamine H3 receptors, which are inhibitory autoreceptors on histaminergic neurons in the brain. This blockade increases histamine release and promotes wakefulness and alertness. When used as an add-on to modafinil, it provides complementary mechanisms to enhance arousal, vigilance, and cognitive performance through multiple neurotransmitter systems.

Approved indications

Common side effects

Key clinical trials

Primary sources

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SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results