Overview
Tasimelteon is a selective dual melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD). Occurring commonly in blind individuals without light perception, this condition is often characterized by periods of night-time insomnia and day-time sleepiness. In blind individuals, a lack of light stimulation causes an extension of the 24-hour circadian cycle and can lead to progressively delayed sleep onset. By activating melatonin receptors MT1 and MT2 in the suprachiasmatic nucleus of the brain, tasimelteon has been shown to improve sleep by resynchronizing the circadian rhythm through its "non-photic" mechanism. Tasimelteon is currently the only drug available for the treatment of N24HSWD and was granted orphan drug status by the FDA in 2010.
Indication
Tasimelteon oral capsules are indicated for the treatment of non-24 hour sleep-wake disorder in adult patients and for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome in patients ≥16 years old. Tasimelteon oral suspension is indicated for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome in patients 3 to 15 years of age.
Associated Conditions
- Non 24 Hour Sleep Wake Disorder
- Sleep Disturbance
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/01 | Phase 3 | Recruiting | |||
2024/11/22 | Phase 3 | Recruiting | |||
2024/03/21 | Phase 1 | Completed | |||
2023/06/28 | Early Phase 1 | Not yet recruiting | |||
2022/10/07 | Phase 1 | Completed | |||
2022/05/05 | Phase 3 | Recruiting | |||
2020/12/03 | Phase 3 | Recruiting | |||
2017/12/14 | Phase 3 | Completed | |||
2017/09/25 | Phase 2 | Completed | |||
2016/05/18 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals, Inc. | 0480-4490 | ORAL | 20 mg in 1 1 | 2/2/2024 | |
| Amneal Pharmaceuticals NY LLC | 69238-2548 | ORAL | 20 mg in 1 1 | 1/24/2023 | |
| Vanda Pharmaceuticals Inc. | 43068-304 | ORAL | 4 mg in 1 mL | 12/4/2020 | |
| Apotex Corp. | 60505-4665 | ORAL | 20 mg in 1 1 | 1/5/2024 | |
| Vanda Pharmaceuticals Inc. | 43068-220 | ORAL | 20 mg in 1 1 | 12/4/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/3/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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