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  • SOLUTION;ORAL - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;ORAL - 6MG/ML

Details:

GTX-104 is a clinical stage, novel formulation of nimodipine being developed for IV infusion in aneurysmal Subarachnoid Hemorrhage patients. It incorporates surfactant micelles as the drug carrier to solubilize nimodipine.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

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 October 23, 2023

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Details:

The company currently intends to use the net proceeds for clinical trial expenses to further the Phase 3 clinical trial for GTX-104, a clinical stage, novel formulation of nimodipine being developed for IV infusion in aSAH patients.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $7.5 million Upfront Cash: Undisclosed

Deal Type: Private Placement September 26, 2023

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Details:

GTX-104 is a clinical stage, novel formulation of nimodipine being developed for IV infusion in aneurysmal Subarachnoid Hemorrhage patients. It incorporates surfactant micelles as the drug carrier to solubilize nimodipine.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 10, 2023

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Details:

GTX-104 is a clinical stage, novel formulation of nimodipine being developed for IV infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients. It incorporates surfactant micelles as the drug carrier to solubilize nimodipine.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

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 July 05, 2023

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Details:

GTX-104 is a clinical stage, novel formulation of nimodipine being developed for IV infusion in aSAH patients. It incorporates surfactant micelles as the drug carrier to solubilize nimodipine.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 08, 2023

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Details:

GTX-104 is a clinical stage, novel formulation of nimodipine being developed for IV infusion in aSAH patients. It incorporates surfactant micelles as the drug carrier to solubilize nimodipine.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

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 April 04, 2023

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Details:

GTX-104 is a novel formulation of nimodipine for IV infusion to treat patients suffering from Subarachnoid Hemorrhage, Acasti recently reported positive results for a pharmacokinetic (PK) study, with intravenous GTX-104 meeting all endpoints.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 14, 2022

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Details:

GTX-104 is a clinical stage, novel formulation of nimodipine being developed for IV infusion in SAH patients. It incorporates surfactant micelles as the drug carrier to solubilize nimodipine.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2022

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Details:

The European Patent Office has provided notice of intention to grant the Company’s composition of matter patent for GTX-104 (nimodipine), an IV formulation of nimodipine for use in the treatment of patients with subarachnoid hemorrhage.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 22, 2022

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Details:

GTX-104 is an intravenous infusion targeting Subarachnoid Hemorrhage (SAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 14, 2021

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Details:

Grace provides Acasti with a pipeline of rare and orphan disease programs. Grace's GTX-104 is a Novel aqueous nanoparticle formulation of water insoluble nimodipine, is believed to potentially improve the management of hypotension and vasospasm in SAH patients.


Lead Product(s): Nimodipine

Therapeutic Area: Neurology Product Name: GTX-104

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Acasti Pharma

Deal Size: $64.0 million Upfront Cash: $64.0 million

Deal Type: Acquisition May 07, 2021

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