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AlgoTherapeutix
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ATX01 (amitriptyline hydrochloride) topical which is investigated in Phase 2 for pain of Erythromelalgia, a rare neurological and vascular disease characterized by painful extremities for which there is no available treatment. The trial is due to read out in H1 2024.


Lead Product(s): Amitriptyline Hydrochloride

Therapeutic Area: Rare Diseases and Disorders Product Name: ATX01

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 12, 2023

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The net proceedings will be used to demonstrate the clinical efficacy of ATX01 (amitriptyline hydrochloride) in Phase 2 in chemotherapy-induced peripheral neuropathy and erythromelalgia.


Lead Product(s): Amitriptyline Hydrochloride

Therapeutic Area: Product Name: ATX01

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Relyens Innovation Santé

Deal Size: $21.2 million Upfront Cash: Undisclosed

Deal Type: Series B Financing March 14, 2023

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ATX01 is a novel, patented, topical formulation of amitriptyline. Its non-systemic mode of action locally inhibits pain signaling in the skin’s nerve fibers whilst minimizing systemic penetration, thus avoiding unwanted toxicity.


Lead Product(s): Amitriptyline

Therapeutic Area: Neurology Product Name: ATX01

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 01, 2022

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ATX01 is a novel and patented topical formulation of amitriptyline. Its non-systemic mode of action locally inhibits pain signaling by the skin’s nerve fibers whilst minimizing systemic penetration, thus avoiding unwanted toxicity.


Lead Product(s): Amitriptyline

Therapeutic Area: Neurology Product Name: ATX01

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 09, 2022

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ATX01, an innovative topical treatment for the pain of peripheral neuropathy successfully reached its safety and pharmacokinetics objectives in Phase I trial, clearing the way for Phase II development in Chemotherapy-Induced Peripheral Neuropathy.


Lead Product(s): Amitriptyline

Therapeutic Area: Oncology Product Name: ATX01

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 November 15, 2021

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AlgoTherapeutix has received approval from the ethics committee and the regulatory authority in the Czech Republic to initiate a Phase 1 clinical trial with ATX01.


Lead Product(s): Amitriptyline

Therapeutic Area: Neurology Product Name: ATX01

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 15, 2020

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U.S. Food and Drug Administration (FDA) has granted ATX01 (proprietary topical amitriptyline) Orphan Drug Designation for the treatment of erythromelalgia. The ATX01 program primarily targets Chemotherapy-Induced Peripheral Neuropathy.


Lead Product(s): Amitriptyline

Therapeutic Area: Rare Diseases and Disorders Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 08, 2020

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