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Details:
The funding helps BioCorRx to focus on the clinical development of BICX104 (naltrexone) a biodegradable, long-acting subcutaneous pellet in combination with Bupropion. It is currently evaluated in preclinical studies for methamphetamine use disorder.
Lead Product(s): Naltrexone,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute on Drug Abuse
Deal Size: $11.0 million Upfront Cash: Undisclosed
Deal Type: Funding February 28, 2024
Details:
IVL3004 (naltrexone) is an opiod antagonist. It is a one-month long-acting injection based on company's IVL-DrugFluidic® technology. It is designed to treat opioid addiction.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: IVL3004
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 October 06, 2023
Details:
The joint research will focus on using Immgenuity’s IMTV014 and Biostax’s Lodonal™ and JKB-122 both independently and together to determine if the immune modulatory effects of Biostax’s drug therapies combined with Immgenuity’s IMTV014 can achieve remission with HIV patients.
Lead Product(s): IMTVO14,Naltrexone
Therapeutic Area: Infections and Infectious Diseases Product Name: IMTVO14
Highest Development Status: PreclinicalProduct Type: Vaccine
Partner/Sponsor/Collaborator: Biostax
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 29, 2023
Details:
The submission to the US Food and Drug Administration (FDA) of an expanded access program application for BICX104 (implantable naltrexone pellet) for the treatment of opioid use disorder (OUD) patients that meet program eligibility criteria.
Lead Product(s): Naltrexone,Magnesium Stearate API
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
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 August 15, 2023
Details:
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of OUD being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed pharmacotherapies.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
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 18, 2023
Details:
Jan123 (naltrexone) is being developed for the treatment of Complex Regional Pain Syndrome (CRPS), an indication that causes severe, chronic pain generally affecting the arms or legs.
Lead Product(s): Naltrexone
Therapeutic Area: Neurology Product Name: Jan123
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 April 18, 2023
Details:
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of OUD being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed pharmacotherapies.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
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 January 19, 2023
Details:
Jan123 (naltrexone) is being developed for the treatment of Complex Regional Pain Syndrome (CRPS), an indication that causes severe, chronic pain generally affecting the arms or legs.
Lead Product(s): Naltrexone
Therapeutic Area: Neurology Product Name: JAN123
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: JanOne
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition January 10, 2023
Details:
Naltrexone is an opioid antagonist, primarily used to manage alcohol and or opioid use disorder by reducing cravings and feelings of euphoria associated with substance abuse disorder.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Love Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 11, 2022
Details:
Naltrexone treatments work to block mu-opioid receptors when administered orally or through injection. The effective blockade of delta‐opioid receptors requires much higher plasma naltrexone concentrations than is achieved by currently approved naltrexone products.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT002
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 October 06, 2022
Details:
The financing by Neovacs will support Pharnext operations and cash requirements, in particular the Phase III PREMIER pivotal study assessing its PTX3003 (baclofen) candidate in CMT1A, a rare debilitating peripheral neuropathy with currently no existing approved therapy.
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PTX3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Neovacs
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Financing October 03, 2022
Details:
BICX104, implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection for the treatment of opioid use disorder (OUD).
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute on Drug Abuse
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2022
Details:
If approved, DLP-160 (6-12 month Naltrexone Implant) is expected to offer a major advancement in the treatment of opioid use disorder by improving medication adherence and reducing relapses.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: DLP-160
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 April 29, 2022
Details:
BICX104 is an eroding subcutaneous implantable pellet that contains 1 g naltrexone and 11 mg magnesium stearate that will be inserted subcutaneously. It will be administered once for 84 days.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
BICX104 is being developed in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under RFA DA-19-002. Part of this supplemental grant will be used to develop and refine systems and strategies at BioCorRx.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute on Drug Abuse
Deal Size: $9.3 million Upfront Cash: Undisclosed
Deal Type: Funding April 11, 2022
Details:
The BICX104 clinical study in two parallel groups of 12 randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once a month intramuscular depot naltrexone injection.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Results from Phase 1 studies demonstrate that OPNT002 produces maximum plasma concentrations that are approximately 50% higher than orally administered naltrexone.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: OPNT002
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 January 20, 2022
Details:
BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD). The company submitted the IND to the FDA last month. The first-in-human clinical trial.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
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 October 07, 2021
Details:
Naltrexone is a medication that is primarily used to manage alcohol or opioid use disorder by reducing cravings or feelings of euphoria associated with substance use disorder.
Lead Product(s): Naltrexone
Therapeutic Area: Neurology 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 September 09, 2021
Details:
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of opioid use disorder (OUD) being developed under BioCorRx Pharmaceuticals, Inc., BioCorRx’s controlled R&D subsidiary.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: BioCorRx
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2021
Details:
This award funding will cover financial cost of the first-in human clinical trial of BICX104 which will assess longevity, safety, and tolerability of BICX104 towards FDA approval.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute on Drug Abuse
Deal Size: $3.5 million Upfront Cash: Undisclosed
Deal Type: Funding September 01, 2021
Details:
The study assessed treatment patterns and HRU among 3,665 patients diagnosed with alcohol dependence who were treated with VIVITROL® (naltrexone for extended-release injectable suspension (XR-NTX)).
Lead Product(s): Naltrexone,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vivitrol
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2021
Details:
This financing agreement for up to 81 million euros will enable Pharnext to strengthen its cash position and continue to develop its pivotal Phase III clinical trial of PXT3003, the PREMIER trial, in Charcot-Marie-Tooth disease type 1A (CMT1A).
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alpha Blue Ocean
Deal Size: $96.0 million Upfront Cash: Undisclosed
Deal Type: Financing June 10, 2021
Details:
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of Opioid Use Disorder (OUD). The company submitted the IND to the FDA last month. The first-in-human clinical trial for BICX104 is expected to commence later this year.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX104
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute of Drug Abuse
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2021
Details:
The new results announced today continue to show sustained treatment benefits for CMT1A patients treated with PXT3003 at High Dose (‘HD’) in the PLEO-CMT-FU Period 2 trial with a data readout at 54 months of total trial time (double-blind + open-label).
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
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 28, 2021
Details:
ARD-301 is comprised of a non-opioid, non-addictive therapy option that has been shown to have activity for improving a broad array of fibromyalgia symptoms in prior clinical studies with LDN.
Lead Product(s): Naltrexone
Therapeutic Area: Musculoskeletal Product Name: ARD-301
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sorrento Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 01, 2021
Details:
Cytocom has submitted an Investigational New Drug (IND) application with updated protocols to the FDA to begin a Phase 2 clinical trial, to evaluate the safety and efficacy of CYTO-205 to slow or halt the progression of the SARS-CoV-2, the virus that causes COVID-19.
Lead Product(s): Naltrexone
Therapeutic Area: Infections and Infectious Diseases Product Name: CYTO-205
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 February 16, 2021
Details:
This is the second published study evaluating efficacy and safety of naltrexone for extended-release injectable suspension plus oral extended-release bupropion administered daily as a combination treatment methamphetamine use disorder.
Lead Product(s): Naltrexone,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vivitrol
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 January 14, 2021
Details:
A combination of two medications, injectable naltrexone and oral bupropion, was safe and effective in treating adults with moderate or severe methamphetamine use disorder in a double-blind, placebo-controlled Phase III clinical trial.
Lead Product(s): Naltrexone,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vivitrol
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 January 13, 2021
Details:
The primary objective of this collaboration is to identify and validate potential treatment responsive CMT1A biomarkers that could be further explored in future clinical studies, in particular the upcoming Phase III study of PXT3003, Pharnext’s lead drug candidate.
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pharnext
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 03, 2020
Details:
In light of uncertainties across many industries due to COVID-19, BioCorRx wanted to reiterate that its pivotal GLP preclinical studies of BICX102, continue to progress and have been uninterrupted by COVID-19 to date.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology 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 May 22, 2020
Details:
Irisys is providing contract development and GMP manufacturing services to BioCorRx Pharmaceuticals for a sterile naltrexone sub-cutaneous implant (BICX102) used in treatment of opioid use disorder and the prevention of relapse following opioid detoxification.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: BICX102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: BioCorRx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 26, 2020
Details:
The grant was awarded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). The grant is for the development of BICX102.
Lead Product(s): Naltrexone
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute on Drug Abuse
Deal Size: $5.7 million Upfront Cash: Undisclosed
Deal Type: Funding January 30, 2020
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