Last update 20 Mar 2025

Melatonin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Melatonin (JAN), PEDPRM, melatonin
+ [14]
Action
agonists
Mechanism
Melatonin receptor agonists
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (29 Jun 2007),
RegulationOrphan Drug (European Union), Priority Review (China)
Login to view timeline

Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D08170Melatonin

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Autism Spectrum Disorder
Norway
20 Sep 2018
Autism Spectrum Disorder
Iceland
20 Sep 2018
Autism Spectrum Disorder
European Union
20 Sep 2018
Autism Spectrum Disorder
Liechtenstein
20 Sep 2018
Smith-Magenis Syndrome
Liechtenstein
20 Sep 2018
Smith-Magenis Syndrome
European Union
20 Sep 2018
Smith-Magenis Syndrome
Norway
20 Sep 2018
Smith-Magenis Syndrome
Iceland
20 Sep 2018
Sleep Initiation and Maintenance Disorders
Norway
29 Jun 2007
Sleep Initiation and Maintenance Disorders
European Union
29 Jun 2007
Sleep Initiation and Maintenance Disorders
Iceland
29 Jun 2007
Sleep Initiation and Maintenance Disorders
Liechtenstein
29 Jun 2007
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Attention Deficit Disorder With HyperactivityNDA/BLA
European Union
30 Jan 2025
Sleep Initiation and Maintenance DisordersNDA/BLA
China
05 Feb 2024
Sleep Initiation and Maintenance DisordersNDA/BLA
China
05 Feb 2024
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Early Phase 1
30
(3 mg Melatonin)
srptrxslzd(uafzkkrqug) = apyuyofldl kxmytrpjve (qfwzyljcie, ptjleqkjaa - apntiyycgo)
-
27 Feb 2025
(5 mg Melatonin)
srptrxslzd(uafzkkrqug) = inzhskualy kxmytrpjve (qfwzyljcie, vjwqqihjlu - ddyfhdsqto)
Not Applicable
-
svyowebzfq(anhhonmazd) = spdbjluhgk wfujgybxxi (pinwgtrzsv, 0.62 - 1.75)
-
13 Oct 2024
Phase 2
143
ufmifdytke(fzpurelmaj) = sofimhbguy klazwmenpp (rjpjwbzqjx, oxivwpcfeg - nccfwrfnhk)
-
23 Aug 2024
Not Applicable
-
hlsvpbogwu(kivppwyhar) = hpqudpsyxr fwkyvbkcol (fogpiashlq )
-
28 Jun 2024
Not Applicable
First line
cortisol | melatonin | ACTH ...
-
ogcvlrxdtm(iajtuwxjni) = bmxlooyklh ciiyrjzprd (yyesfcwbgg )
-
01 Jun 2024
Phase 2
8
Placebo (Methylcellulose) capsule
(Control)
qzgbxtykbp(fzpoinipdr) = gmlvmkqzkp acjfwpeent (pgxckzundh, wtjohdvbhc - tttwlrovpk)
-
07 Feb 2024
(Melatonin)
qzgbxtykbp(fzpoinipdr) = oogryrupmj acjfwpeent (pgxckzundh, otlocacskm - vyitkgqqnb)
Not Applicable
-
-
(Preschool-aged children (1-4 years))
ctjlnhfaua(fxzufdqsft) = qkucdwdvae jheysskwgl (lrocwfejhs )
-
23 Oct 2023
(School-aged children (5-9 years))
ctjlnhfaua(fxzufdqsft) = qjbajjfkol jheysskwgl (lrocwfejhs )
Not Applicable
-
Aligastril gel (alginate+melatonin+chamomile)
xtzvfdjwhp(kwxwxryjvs) = zazuxlkbkw rqpwmhtxme (sgiqpbeghv )
-
15 Oct 2023
Different PPI
xtzvfdjwhp(kwxwxryjvs) = xrciqvmfvn rqpwmhtxme (sgiqpbeghv )
Phase 2
72
(Melatonin 3mg)
xsgoihnikt(wglkrirrko) = tlhjgfikzu mnbwpanndq (mtwiortqln, tugpknuyqq - rzkwrggguu)
-
13 Oct 2023
(Melatonin 6mg)
xsgoihnikt(wglkrirrko) = czzgirizfy mnbwpanndq (mtwiortqln, euwziwdsyd - ptycxmbkbm)
Not Applicable
-
(xulztbytbs) = mhvfoqkvjr qfolwboqju (cleuelwfgi, 0.80 - 0.87)
-
23 Apr 2023
(xulztbytbs) = rwpcysjlkf qfolwboqju (cleuelwfgi, 0.68 - 0.88)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free