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Details:
Stride's Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Truvada Tablets, 200 mg/300 mg, of Gilead Sciences.
Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
Following 90 days of dosing, ATI-2173, in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated with alanine aminotransferase (ALT) normalization and no ALT flares off-treatment.
Lead Product(s): ATI-2173,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: ATI-2173
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 June 25, 2022
Details:
JNJ-3989 is a sub-cutaneous, ribonucleic acid interference (RNAi) therapy candidate which is designed to silence all HBV gene products and intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogues act.
Lead Product(s): JNJ-73763989,Tenofovir Disoproxil Fumarate,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: JNJ-3989
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Details:
The data showed that ATI-2173 alone, or in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated among the cohorts, and ATI-2173 and TDF suppressed HBV DNA and induced declines in biomarkers of cccDNA activity.
Lead Product(s): Clevudine Monophosphate Prp,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: ATI-2173
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 30, 2022
Details:
The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios’ lead Phase 2b clinical candidate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development.
Lead Product(s): ATI-2173,Tenofovir Disoproxil Fumarate,AB-729
Therapeutic Area: Infections and Infectious Diseases Product Name: ATI-2173
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: GordonMD Global Investments
Deal Size: $75.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing November 03, 2021
Details:
The NDA was based on the results from two phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women use in HIV prevention.
Lead Product(s): Cabotegravir,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Cabenuva
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 28, 2021
Details:
The multi-center, double-blinded, placebo-controlled, multiple-dose cohort will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of the combination of ATI-2173, AB-729 and Viread.
Lead Product(s): AB-729,ATI-2173,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: GalNAc-RNAi
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Antios Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 30, 2021
Details:
Lupin has received tentative approval from the United States FDA under the U.S. President’s Emergency Plan for AIDS Relief for its NDA for Dolutegravir, Lamivudine & Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mg, and antiretroviral Fixed Dose Combination.
Lead Product(s): Dolutegravir Sodium,Lamivudine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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:
Lupin has received approval from the United States Food and Drug Administration (USFDA) to market its Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg. The drugs are indicated in combination with other antiretroviral agents for HIV-1 infection.
Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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 07, 2021
Details:
The breakthrough therapy designation is based on efficacy and safety results from HPTN 083, a phase IIb/III clinical trial that compared long-acting, injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg for HIV prevention.
Lead Product(s): Cabotegravir,Tenofovir Disoproxil Fumarate,Emtricitabine
Therapeutic Area: Infections and Infectious Diseases Product Name: Vocabria
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 November 17, 2020
Details:
Interim analysis from HPTN 084 study shows long-acting injectable cabotegravir administered every two months is 89% more effective than daily pills in preventing HIV acquisition in women.
Lead Product(s): Cabotegravir,Tenofovir Disoproxil Fumarate,Emtricitabine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute of Allergy and Infectious Diseases
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets and Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are both combination treatments available as a single pill with similar safety profiles to their reference products.
Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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 02, 2020
Details:
China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF).
Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases Product Name: Truvada
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 11, 2020
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