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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Hetlioz (generic drugs available since 2022-12-12)
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 |
|---|---|---|---|---|
| HETLIOZ | Vanda Pharmaceuticals | N-205677 RX | 2014-01-31 | 1 products, RLD, RS |
| HETLIOZ LQ | Vanda Pharmaceuticals | N-214517 RX | 2020-12-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| hetlioz | New Drug Application | 2022-12-21 |
| tasimelteon | ANDA | 2024-01-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| circadian rhythm sleep disorders | — | D020178 | G47.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TASIMELTEON, HETLIOZ, VANDA PHARMS INC | |||
| 2027-12-01 | ODE-330 | ||
TASIMELTEON, HETLIOZ LQ, VANDA PHARMS INC | |||
| 2027-12-01 | ODE-329 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tasimelteon, Hetlioz, Vanda Pharms Inc | |||
| 11759446 | 2041-02-21 | U-3003 | |
| 10179119 | 2035-08-29 | U-3003 | |
| 11266622 | 2035-08-29 | U-3003 | |
| 10376487 | 2035-07-27 | U-2615, U-3007 | |
| 10071977 | 2035-02-12 | DS, DP | |
| 10829465 | 2035-02-12 | DS, DP | |
| 11566011 | 2035-02-12 | DS, DP | |
| 11760740 | 2035-02-12 | DS, DP | |
| 10610511 | 2034-10-10 | U-2615, U-3007 | |
| 11141400 | 2034-10-10 | U-2615, U-3007 | |
| 11786502 | 2034-10-10 | U-3007, U-3739 | |
| 9730910 | 2034-05-17 | U-2085, U-3005 | |
| RE46604 | 2033-01-25 | U-2147 | |
| 9060995 | 2033-01-25 | U-1710 | |
| 9539234 | 2033-01-25 | U-1934, U-3004 | |
| 9549913 | 2033-01-25 | U-1486 | |
| 9855241 | 2033-01-25 | U-2149 | |
| 10149829 | 2033-01-25 | U-2477, U-3006 | |
| 10449176 | 2033-01-25 | U-2149 | |
| 10610510 | 2033-01-25 | U-2805, U-3009 | |
| 10945988 | 2033-01-25 | U-2149 | |
| 10980770 | 2033-01-25 | U-3106, U-3107 | |
| 11285129 | 2033-01-25 | U-3342, U-3343 | |
| 11633377 | 2033-01-25 | U-2149, U-3003 | |
| 11833130 | 2033-01-25 | U-2149, U-3003 | |
| 11850229 | 2033-01-25 | U-3342, U-3343 | |
| Tasimelteon, Hetlioz Lq, Vanda Pharms Inc | |||
| 11202770 | 2040-12-11 | DP | |
HCPCS
No data
Clinical
Clinical Trials
25 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 disorders | D012893 | — | G47 | 1 | 1 | 6 | 1 | — | 9 |
| Circadian rhythm sleep disorders | D020178 | — | G47.2 | 1 | 1 | 5 | 1 | — | 8 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | 3 | — | — | 3 |
| Smith-magenis syndrome | D058496 | Orphanet_819 | Q93.88 | 1 | 1 | 1 | — | — | 2 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | 1 | — | 1 | — | — | 2 |
| Jet lag syndrome | D020179 | — | G47.25 | — | 1 | 1 | — | — | 2 |
| Dyssomnias | D020920 | — | — | — | 1 | 2 | — | — | 2 |
| Parasomnias | D020447 | — | G47.5 | — | 1 | 2 | — | — | 2 |
| Depression | D003863 | — | F33.9 | — | 1 | 1 | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | 1 | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | 1 | — | — | 1 |
| Chronobiology disorders | D021081 | — | — | — | — | 1 | — | — | 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 insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Rem sleep behavior disorder | D020187 | EFO_0007462 | G47.52 | 1 | — | — | — | — | 1 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tasimelteon |
| INN | tasimelteon |
| 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 class | selective melatonin receptor agonist |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2 |
Identifiers
| PDB | — |
| CAS-ID | 609799-22-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103822 |
| ChEBI ID | 79042 |
| PubChem CID | 10220503 |
| DrugBank | — |
| UNII ID | SHS4PU80D9 (ChemIDplus, GSRS) |
Target
Variants
No data
Financial
Revenue by drug
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Hetlioz – Vanda Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 298 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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5,181 adverse events reported
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