Drug Type Small molecule drug |
Synonyms Melatonin (JAN), PEDPRM, melatonin + [14] |
Target |
Action agonists |
Mechanism Melatonin receptor agonists |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (29 Jun 2007), |
RegulationOrphan Drug (European Union), Priority Review (China) |
Molecular FormulaC13H16N2O2 |
InChIKeyDRLFMBDRBRZALE-UHFFFAOYSA-N |
CAS Registry73-31-4 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Attention Deficit Disorder With Hyperactivity | NDA/BLA | European Union | 30 Jan 2025 | |
Sleep Initiation and Maintenance Disorders | NDA/BLA | China | 05 Feb 2024 | |
Sleep Initiation and Maintenance Disorders | NDA/BLA | China | 05 Feb 2024 |
Early Phase 1 | 30 | (3 mg Melatonin) | srptrxslzd(uafzkkrqug) = apyuyofldl kxmytrpjve (qfwzyljcie, ptjleqkjaa - apntiyycgo) View more | - | 27 Feb 2025 | ||
(5 mg Melatonin) | srptrxslzd(uafzkkrqug) = inzhskualy kxmytrpjve (qfwzyljcie, vjwqqihjlu - ddyfhdsqto) View more | ||||||
Not Applicable | - | svyowebzfq(anhhonmazd) = spdbjluhgk wfujgybxxi (pinwgtrzsv, 0.62 - 1.75) View more | - | 13 Oct 2024 | |||
Phase 2 | 143 | ufmifdytke(fzpurelmaj) = sofimhbguy klazwmenpp (rjpjwbzqjx, oxivwpcfeg - nccfwrfnhk) View more | - | 23 Aug 2024 | |||
Not Applicable | - | hlsvpbogwu(kivppwyhar) = hpqudpsyxr fwkyvbkcol (fogpiashlq ) View more | - | 28 Jun 2024 | |||
Not Applicable | First line cortisol | melatonin | ACTH ... View more | - | ogcvlrxdtm(iajtuwxjni) = bmxlooyklh ciiyrjzprd (yyesfcwbgg ) View more | - | 01 Jun 2024 | ||
Phase 2 | 8 | Placebo (Methylcellulose) capsule (Control) | qzgbxtykbp(fzpoinipdr) = gmlvmkqzkp acjfwpeent (pgxckzundh, wtjohdvbhc - tttwlrovpk) View more | - | 07 Feb 2024 | ||
(Melatonin) | qzgbxtykbp(fzpoinipdr) = oogryrupmj acjfwpeent (pgxckzundh, otlocacskm - vyitkgqqnb) View more | ||||||
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 | - | 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) View more | - | 13 Oct 2023 | ||
(Melatonin 6mg) | xsgoihnikt(wglkrirrko) = czzgirizfy mnbwpanndq (mtwiortqln, euwziwdsyd - ptycxmbkbm) View more | ||||||
Not Applicable | - | (xulztbytbs) = mhvfoqkvjr qfolwboqju (cleuelwfgi, 0.80 - 0.87) | - | 23 Apr 2023 | |||
(xulztbytbs) = rwpcysjlkf qfolwboqju (cleuelwfgi, 0.68 - 0.88) |