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Details:
Hetlioz (tasimelteon) is a melatonin receptor agonist. It is being evaluated in Phase 3 clinical trials for the treatment of insomnia characterized by difficulties with sleep initiation.
Lead Product(s): Tasimelteon
Therapeutic Area: Sleep Product Name: Hetlioz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 2024
Details:
HETLIOZ® (tasimelteon), is a melatonin receptor agonist that is FDA approved for both Non-24-Hour Sleep-Wake Disorder (a serious, chronic circadian rhythm disorder) and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
Lead Product(s): Tasimelteon
Therapeutic Area: Sleep Product Name: Hetlioz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
HETLIOZ® (Tasimelteon), is a melatonin receptor agonist and the first and only medication that's been proven to treat people with Non-24 and nighttime sleep disturbances in SMS.
Lead Product(s): Tasimelteon
Therapeutic Area: Sleep Product Name: Hetlioz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
HETLIOZ® (Tasimelteon) is a melatonin receptor agonist that is FDA approved for both Non-24-Hour Sleep-Wake Disorder (a serious, chronic circadian rhythm disorder) and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
Lead Product(s): Tasimelteon
Therapeutic Area: Sleep Product Name: Hetlioz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license to manufacture and commercialize MSN's version of HETLIOZ® in the U.S. effective March 13, 2035, unless prior to that date Vanda obtains pediatric exclusivity for HETLIOZ.
Lead Product(s): Tasimelteon
Therapeutic Area: Genetic Disease Product Name: Hetlioz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MSN Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 14, 2022
Details:
The applications include a Supplemental New Drug Application (sNDA) for HETLIOZ® capsules and a New Drug Application (NDA) for the liquid formulation of HETLIOZ® for the treatment of adults and children, respectively, with Smith-Magenis Syndrome (SMS).
Lead Product(s): Tasimelteon
Therapeutic Area: Genetic Disease Product Name: Hetlioz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
Following the completion of a Type A Meeting with the U.S. FDA on May 8, 2020, it has reached agreement with the FDA to resubmit its application for HETLIOZ® (tasimelteon) for the treatment of Smith-Magenis Syndrome (SMS).
Lead Product(s): Tasimelteon
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
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