Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Acadia Pharma Announces Health Canada Approval of DAYBUE™ For Rett Syndrome
Details : Daybue (trofinetide) is a weak inhibitor of CYP3A4, which is indicated for the treatment of Rett syndrome, a rare neurodevelopmental disorder.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 16, 2024
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Acadia Submits Trofinetide NDA For Rett Syndrome, Accepted For Filing And Review
Details : Daybue (trofinetide) is a weak inhibitor of CYP3A4, which is indicated for the treatment of Rett syndrome, a rare neurodevelopmental disorder. It is already approved by FDA for the same indication.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Not Applicable
April 22, 2024
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Daybue (trofinetide) is a CYP3A4 inhibitor which helps to stimulate synaptic maturation and overcome the synaptic and neuronal immaturities that are characteristic of Rett syndrome pathophysiology.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Not Applicable
April 17, 2023
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Daybue (trofinetide) is a CYP3A4 inhibitor which helps to stimulate synaptic maturation and overcome the synaptic and neuronal immaturities that are characteristic of Rett syndrome pathophysiology.
Brand Name : Daybue
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 10, 2023
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The NDA is supported by results from the pivotal Phase 3 Lavender study evaluating the efficacy and safety of NNZ-2566 (trofinetide) versus placebo in 187 girls and young women aged 5-20 years with Rett syndrome.
Brand Name : NNZ-2566
Molecule Type : Peptide
Upfront Cash : Not Applicable
September 12, 2022
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : NNZ-2566 (trofinetide) is an investigational drug, is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
Brand Name : NNZ-2566
Molecule Type : Peptide
Upfront Cash : Not Applicable
July 18, 2022
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Trofinetide is an investigational novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.
Brand Name : Trofinetide
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2022
Lead Product(s) : Trofinetide
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trofinetide
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Rare Pediatric Disease Designation
Details : Upon FDA approval of a product with RPD designation, ACADIA may be eligible to receive a Priority Review Voucher, which can be used to obtain FDA review of a New Drug Application for another product.
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 03, 2020
Lead Product(s) : Trofinetide
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trofinetide
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ACADIA announce Rare Pediatric Disease Designation for Trofinetide
Details : Upon FDA approval of a product with RPD designation, the sponsor may be eligible to receive a Priority Review Voucher.
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 03, 2020
Lead Product(s) : Trofinetide
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
LOOKING FOR A SUPPLIER?