Hetlioz
(tasimelteon)ApprovedSmall molecule
Tasimelteon is used to treat non-24-hour sleep-wake disorder, a condition where a person's internal sleep clock doesn't match the 24-hour day, causing them to have irregular sleep patterns.[2] Hetlioz is currently approved and in use across 10 indications[4].[1]
Hetlioz is one of 193 small molecule programs targeting Circadian Rhythm Sleep Disorder. It is currently in Approved.
10
Indications
24
Total Trials
5
Active Trials
192
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
33
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
386 competitors in Major Depressive Disorder
#DrugCompanyPhaseTrials
1Hetlioz
VVanda Pharmaceuticals
Approved
Crestor
AstraZenecaPhase 3
Emend
CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase 3
Quetiapine XR
AstraZenecaPhase 3
Clozaril
LLife Extension Foundation Inc.
Phase 3
Comparator: Pbo
Merck & Co.Phase 3
Levophed
GGeneral Hospital of Ningxia Medical University
Phase 3
Brenipatide
Eli LillyPhase 3
Venlafaxine ER
PfizerPhase 3
DVS-233
PfizerPhase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Sleep-Wake Disorder4 trials
Sleep2 trials
Insomnia2 trials
ESS2 trials
11 more indications
Major Depressive Disorder1 trial
ART1 trial
The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)
Terminated·—·Phase 1·NCT05922995·20 enrolled
Interaction1 trial
Moderate Hepatic Impairment1 trial
Autism Spectrum Disorder1 trial
MPA1 trial
Smoking1 trial
Adolescent1 trial
Renal Impairment1 trial
Sleep Disturbance1 trial
Regulatory
FDA Approval Timeline[5]
Jan 31, 2014
HETLIOZ
NDA NDA205677
Dec 1, 2020
HETLIOZ LQ
NDA NDA214517
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Hetlioz drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for tasimelteon. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Melatonin Receptor Agonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- VVanda Pharmaceuticals
Patent Landscape[6]
Patent Cliff
Jan 25, 2033
Earliest patent expiration — generic entry possible after this date
Patent #Expires
11850229Jan 25, 2033
11826339Jan 25, 2033
RE46604Jan 25, 2033
10149829Jan 25, 2033
11918557Jan 25, 2033
28 more patents
9855241Jan 25, 2033
12201604Jan 25, 2033
9539234Jan 25, 2033
11833130Jan 25, 2033
9060995Jan 25, 2033
10449176Jan 25, 2033
9549913Jan 25, 2033
10980770Jan 25, 2033
10945988Jan 25, 2033
11285129Jan 25, 2033
11633377Jan 25, 2033
10610510Jan 25, 2033
11918556Apr 7, 2033
9730910May 17, 2034
10610511Oct 10, 2034
11786502Oct 10, 2034
11141400Oct 10, 2034
10829465Feb 12, 2035
11760740Feb 12, 2035
11566011Feb 12, 2035
12049457Feb 12, 2035
10071977Feb 12, 2035
10376487Jul 27, 2035
10179119Aug 29, 2035
11266622Aug 29, 2035
11202770Dec 11, 2040
12447141Dec 11, 2040
11759446Feb 21, 2041