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MELATONIN

Phase 2

Sleep Disorder | Small molecule | Other |Sanofi|Trials Updated: Apr 25, 2022

MELATONIN development status

Highest phase Phase 2 run by Southeast Renal Research Institute (NCT01922999)
Phase scored for SNYPhase 1
Registered trials 5 across 5 sponsors since Aug 2013

MELATONIN target and mechanism

Molecular targetMTNR1A, MTNR1B
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL45

Also known as MELATONIN (MELATL07959)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

MELATONIN clinical trials

MELATONIN · 1 trial · 1 indication

Phase 1 1
NCT03514732Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep DisordersSleep Disorder (Healthy Volunteers)
COMPLETED40 Analytics
PHASE1COMPLETED
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Sleep Disorder (Healthy Volunteers)Unlock trial analytics

Study Endpoints

Primary Endpoints

Comparison of the sleep quality
From baseline to Day 21

Difference in the average score of sleep quality

Secondary Endpoints

Comparison of the average scores of sleep quality
From baseline to Day 28
Comparison of time for getting asleep
From baseline to Day 28
Comparison of sleep time
From baseline to Day 28
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Novanuit® Triple ActionEXPERIMENTAL2 capsules of Novanuit® Triple Action once daily for 2 weeks, 30 minutes to 1 hour before bedtime.

Interventions

NameTypeDescription
MELATONIN (MELATL07959)DRUGPharmaceutical form:Capsule Route of administration: Oral
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria : * Healthy men or women volunteers, aged from 20 to 75 years included at the moment of the inclusion visit. * Subject with Body Mass Index (BMI) between 18.5 and 29.9 kg/m² (limits included). * Good general health (based on subject interview about his/her medical history and on ...

Countries:Poland
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Competitive Landscape -Insomnia and Sleep Disorders 22 trials (matched to "Sleep Disorder")

Top 2 of 6 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK1PHASE3Suvorexant
Vanda Pharmaceuticals Inc.VNDA2PHASE3tasimelteon
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Frequently asked questions about MELATONIN

What is MELATONIN used for?

MELATONIN is being studied for sleep disorders. A Phase 1 trial evaluated improvements in sleep quality in healthy volunteers with sleep disorders. It is an investigational small molecule developed by Sanofi, and it is not described as an approved treatment.

What does MELATONIN target?

MELATONIN targets the melatonin receptors MTNR1A and MTNR1B, where it acts as an agonist. By binding and activating these receptors, it is designed to influence sleep regulation, which is the basis for its study in sleep disorders.

Who makes MELATONIN?

MELATONIN is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company associated with this investigational sleep disorder asset.

What phase is MELATONIN in?

MELATONIN is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. It is an investigational small molecule and is not described as FDA approved.

What clinical trials is MELATONIN in?

MELATONIN has been studied in one completed Phase 1 trial, NCT03514732, titled a study to evaluate improvements of the quality of sleep with NOVANUIT Triple Action in healthy volunteers with sleep disorders. It enrolled 40 participants in Poland and was uncontrolled, with no randomization or blinding.

Is MELATONIN the same as MELATONIN (MELATL07959)?

Yes, MELATONIN is also known as MELATONIN (MELATL07959). Both names refer to the same Sanofi investigational small molecule being studied for sleep disorders.