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Find Drugs in Development News & Deals for Linezolid

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  • TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 600MG
  • SOLUTION;INTRAVENOUS - 200MG/100ML (2MG/ML)
  • SOLUTION;INTRAVENOUS - 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAVENOUS - 600MG/300ML (2MG/ML)

Details:

The funding will contribute toward the completion of the NC-009 Pan-Phase 2 clinical trial evaluating the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid, for both drug-sensitive and drug-resistant tuberculosis.


Lead Product(s): TBAJ-876,Pretomanid,Linezolid

Therapeutic Area: Infections and Infectious Diseases Product Name: TBAJ-876

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Australian Government

Deal Size: $11.0 million Upfront Cash: Undisclosed

Deal Type: Funding March 24, 2024

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Details:

TBAJ-876 is a diarylquinoline antibiotic that targets a key enzyme of TB bacteria involved in energy production, it is being evaluated in combination with pretomanid and linezolid, for the treatment for both drug-sensitive and drug-resistant TB.


Lead Product(s): TBAJ-876,Pretomanid,Linezolid

Therapeutic Area: Infections and Infectious Diseases Product Name: TBAJ-876

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 November 16, 2023

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Details:

Lupin intends to commercialize the anti-tuberculosis (TB) medicine, Pretomanid, in approximately 140 countries and territories, including many of the highest TB burden countries around the world.


Lead Product(s): Pretomanid,Bedaquiline,Linezolid

Therapeutic Area: Infections and Infectious Diseases Product Name: PA-824

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Lupin Ltd

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership September 06, 2021

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Details:

U.S.FDA has approved a supplemental New Drug Application for FETROJA® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).


Lead Product(s): Cefiderocol,Linezolid

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fetroja

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 28, 2020

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Details:

The new drug was authorised as part of a three-drug, six month, all-oral regimen for the treatment of adults with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.


Lead Product(s): Pretomanid,Bedaquiline,Linezolid

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PA-824

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

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Details:

FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.


Lead Product(s): Cefiderocol,Linezolid

Therapeutic Area: Pulmonary/Respiratory Diseases 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 01, 2020

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