Wednesday, July 8, 2026

Drug profile · INN

tasimelteon

tasimelteon (HETLIOZ) is a melatonin receptor agonist. Associated with Vanda Pharmaceuticals Netherlands B.V.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Nervous system (N05) N05CH
US status approved
Patents linked 20
Pipeline programs 20
News articles 0
Drug details — tasimelteon
US status
approved
Class
Nervous system (N05)
Route
ORAL
Patents
20
Programs
20
Data quality
0.89

Quick answer

tasimelteon (HETLIOZ) is a melatonin receptor agonist. Associated with Vanda Pharmaceuticals Netherlands B.V.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN tasimelteon
Brand HETLIOZ
Mechanism Melatonin receptor agonist
Target Melatonin receptor
Therapeutic class Nervous system (N05)
Route ORAL
Formulation CAPSULE
ATC code N05CH

Mechanism of action

Melatonin receptor agonist

Primary target: Melatonin receptor

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. TASIMELTEON, HETLIOZ 20 mg hard capsules Phase 3 · Anaxis Pharma · Non-24 Hour Sleep-Wake Disorder
  2. Tasimelteon Phase 3 · Vanda Pharmaceuticals Netherlands · Jet Lag Type Insomnia
  3. Tasimelteon Phase 3 · Vanda Pharmaceuticals Netherlands · Sleep Wake Disorders
  4. Tasimelteon Oral Suspension Phase 3 · Vanda Pharmaceuticals Netherlands · Insomnia Disorder
  5. VP-VEC-162-3108 Phase 3 · Anaxis Pharma · Insomnia Disorder
  6. VP-VEC-162-3502 Phase 3 · Anaxis Pharma · Delayed Sleep-Wake Phase Disorder (DSWPD)
  7. VP-VEC-162-3601 Phase 3 · Vanda Pharmaceuticals Netherlands · Autism Spectrum Disorder
  8. tasimelteon Phase 3 · Vanda Pharmaceuticals Netherlands · Major Depressive Disorder

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 12201604

    Treatment of circadian rhythm disorders

    Expires Mon Jan 16 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12049457

    Highly purified pharmaceutical grade tasimelteon

    Expires Mon Jul 25 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11918556

    Treatment of circadian rhythm disorders

    Expires Mon Feb 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11918557

    Treatment of circadian rhythm disorders

    Expires Mon Feb 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11850229

    Treatment of circadian rhythm disorders

    Expires Mon Dec 21 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11833130

    Treatment of circadian rhythm disorders

    Expires Mon Nov 30 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11826339

    Treatment of circadian rhythm disorders

    Expires Mon Nov 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11786502

    Method of treatment

    Expires Mon Oct 12 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11759446

    Liquid tasimelteon formulations and methods of use thereof

    Expires Mon Sep 14 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11760740

    Highly purified pharmaceutical grade tasimelteon

    Expires Mon Sep 14 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 11633377

    Treatment of circadian rhythm disorders

    Expires Mon Apr 20 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 11566011

    Highly purified pharmaceutical grade tasimelteon

    Expires Mon Jan 26 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 11285129

    Treatment of circadian rhythm disorders

    Expires Mon Mar 24 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 11266622

    Method of treatment

    Expires Mon Mar 03 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 11202770

    Liquid tasimelteon formulations and methods of use thereof

    Expires Mon Dec 16 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 11203581

    Highly purified pharmaceutical grade tasimelteon

    Expires Mon Dec 16 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 11141400

    Method of treatment

    Expires Mon Oct 07 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 10980770

    Treatment of circadian rhythm disorders

    Expires Mon Apr 15 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 10945988

    Treatment of circadian rhythm disorders

    Expires Mon Mar 11 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 10829465

    Highly purified pharmaceutical grade tasimelteon

    Expires Mon Nov 05 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is tasimelteon?

tasimelteon (HETLIOZ) is a melatonin receptor agonist. Associated with Vanda Pharmaceuticals Netherlands B.V.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for tasimelteon?

HETLIOZ is a marketed brand name for tasimelteon. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of tasimelteon?

tasimelteon has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.