melatonin

Small moleculemarketed

Melatonin (5-methoxy N-acetyltryptamine) is a hormone synthesized and released from the pineal gland at night, which acts on specific high affinity G-protein coupled receptors to regulate various aspects of physiology and behaviour, including circadian and seasonal responses, and some retinal, cardiovascular and immunological functions. Melatonin is also made synthetically and available without a prescription as an over-the-counter (OTC) dietary supplement in the U.S. Melatonin supplementation has many uses, however, it has been widely studied for treatment of jet lag and sleep disorders. Parents may consider using melatonin to help their child who has a trouble falling asleep. A medical professional should always evaluate insomnia or other sleeping disorders in children. Additionally, melatonin has been shown to protect against oxidative stress in various, highly divergent experimental systems. There are many reasons for its remarkable protective potential. In mammals, melatonin binds to a number of receptor subtypes including high-affinity (MT1 and MT2) and low-affinity (MT3, nuclear orphan receptors) binding sites, which are distributed throughout the central nervous system and periphery. — NCATS

Clinical trial activity

433 trials · 372 clinical orgs · 0 marketing orgs

Phase 1
75
Phase 2
158
Phase 3
84
Phase 4
59

Earliest trial started Nov 1, 1995 (NCT00869128)

Timeline

1990s

  1. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approved

Chemistry & pharmacology

Loading structure…

SMILES

COC1=CC2=C(NC=C2CCNC(C)=O)C=C1
Mol. weight
232.2783 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 5-methoxy-n-acetyltryptamine
  • 5-methoxy-n-acetyltryptamine
  • bci-049
  • circadin
  • circadin
  • circadin
  • circadin
  • general nutrit
  • health aid
  • heidadouppi
  • icenia
  • life ext
  • melapure
  • melapure
  • melatol
  • melatonin
  • melatonin
  • melatonin
  • melatonin
  • melatonin
  • melatonin
  • melatonin
  • melatonin
  • melatonin
  • melatonine
  • melatonine
  • melatonine
  • n-(2-(5-methoxy-1h-indol-3-yl)ethyl)acetamide
  • n-(2-(5-methoxy-1h-indol-3-yl)ethyl)acetamide
  • n-[2-(5-methoxyindol-3-yl)ethyl]acetamide
  • n-[2-(5-methoxyindol-3-yl)ethyl]acetamide
  • n-acetyl-5-methoxytryptamine
  • n-acetyl-5-methoxytryptamine
  • n-acetyl-5-methoxytryptamine
  • n-acetyl-5-methoxytryptamine
  • natrol
  • natrol
  • nature's blend
  • natures bounty
  • quality health
  • s.gard
  • travelag
  • vespro
  • vytalonin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07221968Phase 2Jul 1, 2026Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Johns Hopkins University
NCT07305350Phase 2Dec 10, 2025University of Child Health Sciences and Children's Hospital, Lahore
NCT07096635N/AOct 1, 2025Assiut University
NCT07138443N/AAug 31, 2025Baylor University
NCT07046429N/AAug 5, 2025American Association for the Study of Liver Diseases, Cornell University
NCT07067307Phase 1/Phase 2 (Phase 2)Jul 31, 2025Mansoura University
NCT07036796Phase 2Jul 4, 2025Ain Shams University
NCT07036367Phase 4Jul 1, 2025Al Azhar University
NCT07169383Phase 2Jun 28, 2025PAEC General Hospital, Islamabad
NCT07162272Phase 4Jun 25, 2025Ain Shams University
NCT06949904Phase 1/Phase 2 (Phase 2)May 31, 2025College of Physicians and Surgeons Pakistan
NCT07003243Phase 1May 26, 2025University of Baghdad
NCT06996171N/AMay 5, 2025CMH Kharian Medical College
NCT06935292Phase 2/Phase 3 (Phase 3)Apr 30, 2025Tanta University
NCT07062757N/AMar 30, 2025Bezmialem University
NCT06872944Early Phase 1 (Phase 1)Mar 21, 2025Cairo University
NCT06859957Phase 3Mar 19, 2025Erasmus University Rotterdam
NCT07307677N/AMar 11, 2025Bangladesh Medical University
NCT06802913Early Phase 1 (Phase 1)Feb 28, 2025Woolcock Institute of Medical Research
NCT06846086Phase 1Feb 20, 2025Tanta University
Showing 20 of 433 trials
Page 1 / 22

Organizations

Research & Development (372)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of CopenhagenAcademic/Hospital201642005
Ain Shams UniversityAcademic/Hospital191842013
Harvard UniversityAcademic/Hospital161352005
Neurim Pharmaceuticals Ltd.For profit12941995
Oregon Health and Science UniversityAcademic/Hospital9731997
Tel Aviv UniversityAcademic/Hospital9942004
Cairo UniversityAcademic/Hospital8842018
Aarhus UniversityAcademic/Hospital7552012
National Institutes of Health (NIH)Government7131997
Tanta UniversityAcademic/Hospital7752012
University of Texas at HoustonAcademic/Hospital6642004
Emory UniversityAcademic/Hospital5422009
Isfahan UniversityAcademic/Hospital5532010
Kuhnil Pharmaceutical Co., Ltd.For profit5332011
University of California, San DiegoAcademic/Hospital5432004
University of Sao PauloAcademic/Hospital5442015
University of TorontoAcademic/Hospital5532010
Al Azhar UniversityAcademic/Hospital4332023
Alexandria UniversityAcademic/Hospital4422018
Duquesne UniversityAcademic/Hospital4422008
372 organizations
Page 1 / 19