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Details:
Contrave, also marketed as Mysimba is an extended release fixed dose combination of naltrexone HCL/bupropion HCL indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults.
Lead Product(s): Naltrexone Hydrochloride,Bupropion Hydrochloride
Therapeutic Area: Nutrition and Weight Loss Product Name: Contrave
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2023
Details:
Under this agreement, Hamden will have worldwide exclusive rights to sell, market and distribute the HALB patented low-dose Naltrexone medication, and the HALB proprietary Vita-Shield-Max TM Nutraceutical Product.
Lead Product(s): Naltrexone Hydrochloride
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hamden Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 14, 2022
Details:
PXT3003 (baclofen) completed an international Phase III trial with positive topline results for the treatment of CharcotMarie-Tooth disease type 1A (‘CMT1A’) and benefits from orphan drug status in Europe and the United States.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,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 September 13, 2022
Details:
PXT3003 (baclofen) is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day for the treatment of Charcot-Marie-Tooth disease type 1A.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,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 September 12, 2022
Details:
LYVISPAH is bioequivalent to oral baclofen tablets and provides flexible, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Musculoskeletal Product Name: Lyvispah
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 01, 2022
Details:
New data from the ongoing Open-Label Phase III Extension Study of PXT3003 (baclofen), the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total trial time.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,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 May 16, 2022
Details:
Phase 1 clinical trial data showed that SP-104 (naltrexone hydrochloride) treated healthy volunteers and had lower rates of adverse events, as compared with immediate release naltrexone -treated volunteers.
Lead Product(s): Naltrexone Hydrochloride
Therapeutic Area: Musculoskeletal Product Name: SP-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 11, 2022
Details:
Statera will receive milestones, new indications and royalties, Crohn’s disease and COVID-19 indications and regulatory approvals, payments from Immune Therapeutics in exchange for Statera’s rights to any product containing low-dose naltrexone as an active ingredient.
Lead Product(s): Naltrexone Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Product Name: STAT-205
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Immune Therapeutics
Deal Size: $402.0 million Upfront Cash: $2.0 million
Deal Type: Agreement April 27, 2022
Details:
STAT-205 may show promise in treating both acute COVID infections and long COVID in this manner. Preliminary in vitro data demonstrated the drug’s ability to slow or halt the progression of SARS-CoV-2 (the virus that causes COVID-19) in human lung cells.
Lead Product(s): Naltrexone Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Product Name: STAT-205
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 02, 2022
Details:
The Part A of the trial evaluated three dose levels of PF614 showed positive review from the Phase 1b tria, independent Safety Review Committee allowed the trial to proceed to the next dose level.
Lead Product(s): Oxycodone Prodrug,Nafamostat,Naltrexone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: PRF06104
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 04, 2022
Details:
CX-101 is an investigational drug that is being studied for smoking cessation.The Phase 3 program builds on the successful Phase 2b findings and evaluates a mixed-weight population at a fixed-dose combination of CX-101 (naltrexone/bupropion 32 mg/360 mg total daily dose).
Lead Product(s): Naltrexone Hydrochloride,Bupropion Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: CX-101
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 21, 2021
Details:
PXT3003 is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day used in Charcot-Marie-Tooth Disease Type 1A.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,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 October 18, 2021
Details:
PXT3003 is a novel drug candidate for the treatment of CMT1A and has been granted both Orphan Drug Designation and Fast Track Designation by the US Food and Drug Administration.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Neurology Product Name: Undisclosed
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 June 10, 2020
Details:
All existing data indicate that PXT3003 is a safe and well tolerated drug combination.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 18, 2020
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