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Details:
Ingrezza (valbenazine) a new sprinkle formulation of capsules which is selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. FDA for the treatment adults with tardive dyskinesia and chorea associated with Huntington's disease (HD).
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza Sprinkle
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2024
Details:
Ingrezza (valbenazine) a new sprinkle formulation of capsules PDUFA target action date of April 30, 2024 and it is selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. FDA for the treatment chorea associated with Huntington's disease (HD).
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
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 14, 2023
Details:
INGREZZA® (valbenazine) Capsules is the selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD).
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2023
Details:
Valbenazine works by reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2023
Details:
The sNDA for valbenazine for the treatment of chorea associated with Huntington disease is supported by data from two clinical studies, including the Phase 3 study and the on-going KINECT-HD2 open-label rollover study, with more than 150 patients with Huntington disease.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Genetic Disease Product Name: Ingrezza
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 December 22, 2022
Details:
INGREZZA® (valbenazine) Capsule, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is an FDA-approved product indicated for the treatment of adults with tardive dyskinesia.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
INGREZZA® (valbenazine), selective vesicular monoamine transporter 2 inhibitor, indicated for treatment of adults with tardive dyskinesia, condition associated with uncontrollable, abnormal, and repetitive movements of face, torso, and/or other body parts.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Genetic Disease Product Name: Ingrezza
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 November 03, 2022
Details:
INGREZZA (valbenazine), a selective VMAT2 inhibitor, work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
INGREZZA (valbenazine), a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, indicated for treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal, and repetitive movements of face, torso or other body parts.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
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 23, 2022
Details:
INGREZZA, a selective vesicular monoamine transporter 2 inhibitor, is FDA-approved product indicated for treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso, and/or other body parts.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
New analysis from the KINECT program and long-term extension studies found that long-term use of INGREZZA® (valbenazine) led to substantial improvements in patients ≥ 65 years with tardive dyskinesia, the first TD-specific vesicular monoamine transporter 2 inhibitor.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
Data include a post hoc analysis from KINECT 4, a long-term Phase 3 study, demonstrating robust clinically meaningful reductions in TD symptoms at 48 weeks with once-daily INGREZZA® (valbenazine) capsules.
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2021
Details:
Analysis from the KINECT 4 Phase III open-label study that demonstrated the effect of INGREZZA capsules on the overall severity of abnormal movements in adult patients living with tardive dyskinesia based on item 8 of the abnormal involuntary movement scale (AIMS).
Lead Product(s): Valbenazine Tosylate
Therapeutic Area: Neurology Product Name: Ingrezza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
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