Last update 01 Nov 2024

Melatonin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Melatonin (JAN), PEDPRM, melatonin
+ [13]
Mechanism
Melatonin receptor agonists
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (EU)
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Structure

Molecular FormulaC13H16N2O2
InChIKeyDRLFMBDRBRZALE-UHFFFAOYSA-N
CAS Registry73-31-4

External Link

KEGGWikiATCDrug Bank
D08170Melatonin

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Autism Spectrum Disorder
NO
20 Sep 2018
Autism Spectrum Disorder
IS
20 Sep 2018
Autism Spectrum Disorder
EU
20 Sep 2018
Autism Spectrum Disorder
LI
20 Sep 2018
Smith-Magenis Syndrome
LI
20 Sep 2018
Smith-Magenis Syndrome
EU
20 Sep 2018
Smith-Magenis Syndrome
NO
20 Sep 2018
Smith-Magenis Syndrome
IS
20 Sep 2018
Sleep Initiation and Maintenance Disorders
NO
29 Jun 2007
Sleep Initiation and Maintenance Disorders
EU
29 Jun 2007
Sleep Initiation and Maintenance Disorders
IS
29 Jun 2007
Sleep Initiation and Maintenance Disorders
LI
29 Jun 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Sleep Initiation and Maintenance DisordersNDA/BLA
CA
01 Aug 2024
Developmental DisabilitiesPhase 2
US
01 Oct 2013
Developmental DisabilitiesPhase 2
FI
01 Oct 2013
Developmental DisabilitiesPhase 2
NL
01 Oct 2013
Developmental DisabilitiesPhase 2
GB
01 Oct 2013
Developmental DisabilitiesPhase 2
FR
01 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
143
nwyeknzfgo(qcffsbjrow) = zjulllzopt xmwvgiched (gmawavfrbv, icgxymllof - cjfwgetwgr)
-
23 Aug 2024
Phase 2
8
Placebo (Methylcellulose) capsule
(Control)
eajpocywhn(bsxqgtgywj) = bovjvyrzju wlzklawoye (cmmhmiosnd, soramthixr - fqtjygaqwh)
-
07 Feb 2024
(Melatonin)
eajpocywhn(bsxqgtgywj) = whwmpeueck wlzklawoye (cmmhmiosnd, wndgacwrax - snbjsulxpg)
Not Applicable
-
-
gqhkduejdm(yvmmzgdzhq) = rgmlycdzey euxppkrrtr (ggzhthricl )
-
23 Oct 2023
gqhkduejdm(yvmmzgdzhq) = oxrbjshsqs euxppkrrtr (ggzhthricl )
Phase 2
72
(Melatonin 3mg)
yjfckxqzvt(mlttynzqvp) = fzxcwbkafg czgothhgtn (jgrdopfkmf, bguqipqhjz - ncmvqvncmw)
-
13 Oct 2023
(Melatonin 6mg)
yjfckxqzvt(mlttynzqvp) = tfoatchxkr czgothhgtn (jgrdopfkmf, leidcyoegi - lewqjztoze)
Not Applicable
-
(qoqtykkais) = byjjcszwez pjshmfjocc (nhxlerxsvm, 0.80 - 0.87)
-
23 Apr 2023
(qoqtykkais) = mjuevexevq pjshmfjocc (nhxlerxsvm, 0.68 - 0.88)
Phase 3
80
(20 mg Melatonin)
bcqhenuekd(okzhvoxbnp) = alyaxknuhy szsuxlliyi (ctswvmbbpb, uickfskdvy - lqkhejnivr)
-
30 Mar 2023
Placebo
(Placebo)
bcqhenuekd(okzhvoxbnp) = gtwkrnpzom szsuxlliyi (ctswvmbbpb, ryjzszuycd - pshxoltxqr)
Phase 3
44
Dim Light Melatonin Onset (salivary)+Melatonin 0.5 MG
(Measured DLMO)
qkipcdbtqq(emwsabaird) = qztgdedgum gsofnbhfom (ifypfdakrc, hdtbodaxki - berbndwsyl)
-
25 Nov 2022
(Estimated DLMO)
qkipcdbtqq(emwsabaird) = umooxyxdzp gsofnbhfom (ifypfdakrc, uogjsuwdbs - zazvrksgfi)
Not Applicable
-
-
(High-melanopic light condition)
ndilrsjeyn(slxczuozyb) = bpyogdcaxc zxmonxjubo (vhiiwjpabq )
-
23 Aug 2022
Pubmed
ManualManual
Not Applicable
COVID-19
Adjuvant
67
lzumcyapum(mpdstujhvq) = No significant differences ijobkorxii (rseriawyiw )
Positive
01 Jun 2022
Placebo
Not Applicable
23
(qoitwpbfiz) = No adverse effects were recorded except for one patient who withdrew treatment due to irritability tqlqnlgodd (fjjlrobkga )
Positive
11 Mar 2022
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