API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
0
Listed Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
AB-729 is a subcutaneously-delivered RNAi therapeutic specifically designed to reduce all HBV viral antigens, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to virus.
Lead Product(s): AB-729,Vebicorvir,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: AB-729
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Assembly Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus.
Lead Product(s): AB-729,Vebicorvir,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: AB-729
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Assembly Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
ABI-H0731 (Vebicorvir) a first-generation selective inhibition of HBV DNA replication core protein, has demonstrated effective antiviral activity in chronic hepatitis B patients.
Lead Product(s): Vebicorvir,ATI-2173,Tenofovir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
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 08, 2022
Details:
ATI-2173, once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate, only active site polymerase inhibitor nucleotide for HBV in clinical development.
Lead Product(s): Clevudine Monophosphate Prodrug,Tenofovir,Vebicorvir
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 April 26, 2022
Details:
ABI-H0731 (Vebicorvir), is a first-generation core inhibitors has been shown to be well-tolerated and statistically superior in antiviral activity in hepatitis B virus DNA suppression.
Lead Product(s): Vebicorvir,AB-729,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
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 04, 2022
Details:
ABI-H0731, a first-generation hepatitis B virus (HBV) core protein inhibitor, has demonstrated effective antiviral activity in chronic hepatitis B (CHB) patients also exhibited selective inhibition of HBV DNA replication.
Lead Product(s): Vebicorvir,Entecavir,Pegylated-interferon Alpha
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
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 01, 2021
Details:
ATI-2173 has, to date, demonstrated a generally well-tolerated safety profile, leveraging a unique ASPIN mechanism in clinical development to empower combination therapy.
Lead Product(s): ATI-2173,Vebicorvir
Therapeutic Area: Infections and Infectious Diseases Product Name: ATI-2173
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Antios Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 19, 2021
Details:
Plasma Cmin values for VBR, 2158, and 3733 are significantly above protein-adjusted EC50 values for antiviral activity, and plasma Cmin values of 2158 and 3733 are significantly above protein-adjusted EC50 values for cccDNA prevention.
Lead Product(s): Vebicorvir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
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 23, 2021
Details:
Sequence analyses were conducted for virologically-suppressed patients with chronic HBV enrolled in the Phase 2 Study 201 and open-label extension Study 211 of VBR in combination with a nucleos(t)ide reverse transcriptase inhibitor (NrtI) who discontinued treatment.
Lead Product(s): Vebicorvir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
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 09, 2021
Details:
Trial will evaluate Assembly’s core inhibitor candidate, vebicorvir, with Arbutus’ RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy.
Lead Product(s): Vebicorvir,AB-729,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Details:
Assembly Biosciences is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir (VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to concentrate its research and development efforts on finite and curative HBV therapies.
Lead Product(s): Vebicorvir,GalNAc-RNAi,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
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 25, 2021
Details:
In Phase 2 clinical trials, first-generation core inhibitor vebicorvir administered with nucleos(t)ide analogue reverse transcriptase inhibitor therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression to NrtI therapy alone.
Lead Product(s): Vebicorvir,Tenofovir Alafenamide,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
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 02, 2020
Details:
Assembly’s novel core inhibitor vebicorvir in combination with standard-of-care NrtI continues to demonstrate a favorable safety and tolerability profile, with no observed treatment-emergent resistance in patients with HBeAg negative chronic HBV infection.
Lead Product(s): Vebicorvir,Entecavir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
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 August 28, 2020
Details:
BeiGene acquires exclusive development and commercialization rights to ABI-H0731, ABIH2158, and ABI-H3733 in China
Lead Product(s): Vebicorvir
Therapeutic Area: Infections and Infectious Diseases Product Name: ABI-H0731
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: $540.0 million Upfront Cash: $40.0 million
Deal Type: Collaboration July 20, 2020
Details:
Data demonstrate turnover is faster than previously described for cccDNA, a necessary component required for the establishment and persistence of HBV infection .
Lead Product(s): Vebicorvir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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 April 06, 2020