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Details:
FDA has approved ONYDA™ XR (clonidine hydrochloride), a once-a-day extended-release oral suspension for the treatment of ADHD in pediatric patients six years and older.
Lead Product(s): Clonidine
Therapeutic Area: Psychiatry/Psychology Product Name: Onyda
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 29, 2024
Details:
JTA-004 consists of a unique mix of plasma proteins, hyaluronic acid, a natural component of knee synovial fluid and a fast-acting analgesic. It was designed to provide added lubrication and protection to the arthritic joint cartilage and to alleviate osteoarthritis pain.
Lead Product(s): Clonidine,Hyaluronic Acid
Therapeutic Area: Musculoskeletal Product Name: JTA-004
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 May 17, 2023
Details:
Validive® (clonidine hydrochloride) is a novel mucobuccal tablet formulation, indiacted for oropharyngeal cancer. It agonizes the alpha-2 adrenergic receptor on macrophages, decreasing the release of the destructive cytokines that are produced in response to radiotherapy.
Lead Product(s): Clonidine
Therapeutic Area: Immunology Product Name: Validive
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 March 27, 2023
Details:
Validive® (clonidine hydrochloride) is a novel mucobuccal tablet (MBT) formulation of clonidine. The mucobuccal tablet provides for prolonged local delivery of clonidine to the regions of oral mucosal radiation damage in oropharyngeal cancer (OPC) patients.
Lead Product(s): Clonidine
Therapeutic Area: Gastroenterology Product Name: Validive
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
Validive® (clonidine HCl MBT) is a novel mucobuccal tablet (MBT) formulation of clonidine. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial showed reduced incidence and duration of SOM and improvement of oral mucositis-related symptoms.
Lead Product(s): Clonidine
Therapeutic Area: Gastroenterology Product Name: Validive
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 05, 2022
Details:
The launch of Nexiclon XR, the only once-daily clonidine extended-release tablets is based on Tris's LiquiXR drug delivery technology, which has led to the development of multiple first-in-category products indicated for treatment of hypertension.
Lead Product(s): Clonidine
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Nexiclon
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 03, 2022
Details:
This partnership aligns perfectly with Sabal’s mission to support commercial launch for two products, Nexiclon™ XR and Fibricor®, by helping them deliver their products to physicians and patients who need them.
Lead Product(s): Clonidine
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Nexiclon XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Athena Bioscience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 22, 2022
Details:
The trial, which began earlier this year in the US, is evaluating Validive® (clonidine HCl MBT) to prevent the onset of severe oral mucositis (SOM) in oropharyngeal cancer (OPC) patients treated with chemoradiotherapy.
Lead Product(s): Clonidine
Therapeutic Area: Oncology Product Name: Validive
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
The VOICE study evaluates Validive® for the prevention of severe oral mucositis (SOM) in oropharyngeal cancer patients. SOM results from the chemoradiation used to treat oropharyngeal cancer (OPC).
Lead Product(s): Clonidine
Therapeutic Area: Oncology Product Name: Validive
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2021
Details:
This analysis provided the rationale for the design of Monopar’s Phase 2b/3 VOICE trial, which is open and accruing oropharyngeal cancer patients in the US.
Lead Product(s): Clonidine
Therapeutic Area: Oncology Product Name: Validive
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2021
Details:
Patent provide claims covering “Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy”.
Lead Product(s): Clonidine
Therapeutic Area: Gastroenterology Product Name: Validive
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020