Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Tasimelteon
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Vanda Announces FDA Update on Supplemental NDA for HETLIOZ in Insomnia Treatment
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.
Brand Name : Hetlioz
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 05, 2024
Lead Product(s) : Tasimelteon
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tasimelteon
Therapeutic Area : Sleep
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Vanda Pharmaceuticals Responds to Ruling in HETLIOZ® ANDA Litigation
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...
Brand Name : Hetlioz
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 13, 2022
Lead Product(s) : Tasimelteon
Therapeutic Area : Sleep
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tasimelteon
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Hetlioz
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 07, 2022
Lead Product(s) : Tasimelteon
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tasimelteon
Therapeutic Area : Sleep
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Vanda Pharmaceuticals Announces Presentations at SLEEP 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 ...
Brand Name : Hetlioz
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 31, 2022
Lead Product(s) : Tasimelteon
Therapeutic Area : Sleep
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tasimelteon
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : MSN Laboratories
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Vanda Pharmaceuticals Settles HETLIOZ® Patent Litigation with MSN
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.
Brand Name : Hetlioz
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 14, 2022
Lead Product(s) : Tasimelteon
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : MSN Laboratories
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Tasimelteon
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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).
Brand Name : Hetlioz
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 03, 2020
Lead Product(s) : Tasimelteon
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tasimelteon
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 13, 2020
Lead Product(s) : Tasimelteon
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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