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Ramelteon
Rozerem (ramelteon) is a small molecule pharmaceutical. Ramelteon was first approved as Rozerem on 2005-07-22. It is used to treat sleep initiation and maintenance disorders in the USA. The pharmaceutical is active against melatonin receptor type 1B and melatonin receptor type 1A.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Rozerem (generic drugs available since 2013-07-26)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ramelteon
Tradename
Company
Number
Date
Products
ROZEREMTakedaN-021782 RX2005-07-22
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ramelteonANDA2023-06-15
rozeremNew Drug Application2021-03-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sleep initiation and maintenance disorders—D007319F51.01
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CH: Melatonin receptor agonists, hypnotics and sedatives
— N05CH02: Ramelteon
HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10———426
MenopauseD008593EFO_0003922N95———1—1
Diabetic neuropathiesD003929EFO_1000783———1—1
Myocardial ischemiaD017202EFO_1001375I20-I25———1—1
Diabetes mellitusD003920EFO_0000400E08-E13———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4———26
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Arterial occlusive diseasesD001157EFO_0009085————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRAMELTEON
INNramelteon
Description
N-[2-[(8S)-2,6,7,8-tetrahydro-1H-cyclopenta[e]benzofuran-8-yl]ethyl]propanamide is a member of indanes.
Classification
Small molecule
Drug classselective melatonin receptor agonist
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Identifiers
PDB6ME9
CAS-ID196597-26-9
RxCUI596205
ChEMBL IDCHEMBL1218
ChEBI ID—
PubChem CID208902
DrugBankDB00980
UNII ID901AS54I69 (ChemIDplus, GSRS)
Target
Agency Approved
MTNR1B
MTNR1B
MTNR1A
MTNR1A
Organism
Homo sapiens
Gene name
MTNR1B
Gene synonyms
NCBI Gene ID
4544
Protein name
melatonin receptor type 1B
Protein synonyms
mel1b receptor, melatonin receptor MEL1B
Uniprot ID
P49286
Mouse ortholog
Mtnr1b (244701)
melatonin receptor type 1B (Q8CIQ6)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,439 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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3,373 adverse events reported
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