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AboutPricing
Drug ReportsTasimelteon
Hetlioz(tasimelteon)
Hetlioz, Tasimelteon (tasimelteon) is a small molecule pharmaceutical. Tasimelteon was first approved as Hetlioz on 2014-01-31. It is used to treat circadian rhythm sleep disorders in the USA. It has been approved in Europe to treat circadian rhythm sleep disorders. The pharmaceutical is active against melatonin receptor type 1A and melatonin receptor type 1B.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
occupational diseasesD009784
mental disordersD001523
Trade Name
FDA
EMA
Hetlioz, Tasimelteon
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tasimelteon
Tradename
Company
Number
Date
Products
HETLIOZVanda PharmaceuticalsN-205677 RX2014-01-31
1 products, RLD, RS
HETLIOZ LQVanda PharmaceuticalsN-214517 RX2020-12-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
hetliozNew Drug Application2022-12-21
tasimelteonANDA2025-04-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
circadian rhythm sleep disorders—D020178G47.2
Agency Specific
FDA
EMA
Expiration
Code
TASIMELTEON, HETLIOZ, VANDA PHARMS INC
2027-12-01ODE-330
TASIMELTEON, HETLIOZ LQ, VANDA PHARMS INC
2027-12-01ODE-329
Patent Expiration
Patent
Expires
Flag
FDA Information
Tasimelteon, Hetlioz, Vanda Pharms Inc
117594462041-02-21U-3003
101791192035-08-29U-3003
112666222035-08-29U-3003
103764872035-07-27U-2615, U-3007
100719772035-02-12DS, DP
108294652035-02-12DS, DP
115660112035-02-12DS, DP
117607402035-02-12DS, DP
106105112034-10-10U-2615, U-3007
111414002034-10-10U-2615, U-3007
117865022034-10-10U-3007, U-3739
97309102034-05-17U-2085, U-3005
RE466042033-01-25U-2147
90609952033-01-25U-1710
95392342033-01-25U-1934, U-3004
95499132033-01-25U-1486
98552412033-01-25U-2149
101498292033-01-25U-2477, U-3006
104491762033-01-25U-2149
106105102033-01-25U-2805, U-3009
109459882033-01-25U-2149
109807702033-01-25U-3106, U-3107
112851292033-01-25U-3342, U-3343
116333772033-01-25U-2149, U-3003
118331302033-01-25U-2149, U-3003
118502292033-01-25U-3342, U-3343
Tasimelteon, Hetlioz Lq, Vanda Pharms Inc
112027702040-12-11DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CH: Melatonin receptor agonists, hypnotics and sedatives
— N05CH03: Tasimelteon
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep wake disordersD012893—G471171—10
Circadian rhythm sleep disordersD020178—G47.21161—9
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep initiation and maintenance disordersD007319—F51.01——4——4
Smith-magenis syndromeD058496Orphanet_819Q93.88111——2
Autism spectrum disorderD000067877—F84.01—1——2
Chronobiology disordersD021081————2——2
Jet lag syndromeD020179—G47.25—11——2
DyssomniasD020920———12——2
ParasomniasD020447—G47.5—12——2
DepressionD003863—F33.9—11——1
Major depressive disorderD003865EFO_0003761F22—11——1
Depressive disorderD003866EFO_1002014F32.A—11——1
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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———6————6
Renal insufficiencyD051437—N191————1
Liver diseasesD008107EFO_0001421K70-K771————1
Hepatic insufficiencyD048550——1————1
Rem sleep behavior disorderD020187EFO_0007462G47.521————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTasimelteon
INNtasimelteon
Description
Tasimelteon is a member of the class of 1-benzofurans that is propionamide in which one of the amide hydrogens is replaced by a [(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl group. A melatonin receptor agonist used for the treatment of non-24-hour sleep-wake disorder. It has a role as a melatonin receptor agonist. It is a monocarboxylic acid amide, a member of 1-benzofurans and a member of cyclopropanes. It is functionally related to a propionamide.
Classification
Small molecule
Drug classselective melatonin receptor agonist
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Structure (InChI/SMILES or Protein Sequence)
CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Identifiers
PDB—
CAS-ID609799-22-6
RxCUI—
ChEMBL IDCHEMBL2103822
ChEBI ID79042
PubChem CID10220503
DrugBankDB09071
UNII IDSHS4PU80D9 (ChemIDplus, GSRS)
Target
Agency Approved
MTNR1A
MTNR1A
MTNR1B
MTNR1B
Organism
Homo sapiens
Gene name
MTNR1A
Gene synonyms
NCBI Gene ID
4543
Protein name
melatonin receptor type 1A
Protein synonyms
mel1a receptor
Uniprot ID
P48039
Mouse ortholog
Mtnr1a (17773)
melatonin receptor type 1A (Q61184)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Hetlioz – Vanda Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 343 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,612 adverse events reported
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