API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
USA (Orange Book)
0
Europe
Canada
0
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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