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Molecular Weight | 277.28 g/mol |
---|---|
Molecular Formula | C12H15N5O3 |
XLogP3 | -0.8 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 2 |
Exact Mass | 277.11748936 g/mol |
Monoisotopic Mass | 277.11748936 g/mol |
Topological Polar Surface Area | 126 A^2 |
Heavy Atom Count | 20 |
Formal Charge | 0 |
Complexity | 480 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 4 | |
---|---|
Drug Name | Baraclude |
PubMed Health | Entecavir (By mouth) |
Drug Classes | Antiviral |
Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
Active Ingredient | Entecavir |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | 0.5mg; 0.05mg/ml; 1mg |
Market Status | Prescription |
Company | Bristol Myers Squibb |
2 of 4 | |
---|---|
Drug Name | Entecavir |
PubMed Health | Entecavir (By mouth) |
Drug Classes | Antiviral |
Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
Active Ingredient | Entecavir |
Dosage Form | Tablet |
Route | Oral |
Strength | 0.5mg; 1mg |
Market Status | Prescription |
Company | Teva Pharms Usa |
3 of 4 | |
---|---|
Drug Name | Baraclude |
PubMed Health | Entecavir (By mouth) |
Drug Classes | Antiviral |
Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
Active Ingredient | Entecavir |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | 0.5mg; 0.05mg/ml; 1mg |
Market Status | Prescription |
Company | Bristol Myers Squibb |
4 of 4 | |
---|---|
Drug Name | Entecavir |
PubMed Health | Entecavir (By mouth) |
Drug Classes | Antiviral |
Drug Label | BARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,... |
Active Ingredient | Entecavir |
Dosage Form | Tablet |
Route | Oral |
Strength | 0.5mg; 1mg |
Market Status | Prescription |
Company | Teva Pharms Usa |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24305
Submission : 2010-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-10
Pay. Date : 2013-08-27
DMF Number : 27401
Submission : 2013-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-12
Pay. Date : 2013-05-21
DMF Number : 24601
Submission : 2011-01-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-01-29
DMF Number : 23663
Submission : 2010-05-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-01
Pay. Date : 2013-03-18
DMF Number : 26307
Submission : 2012-08-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27066
Submission : 2013-04-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-23
Pay. Date : 2013-11-21
DMF Number : 27719
Submission : 2013-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-28
Pay. Date : 2013-07-02
DMF Number : 25549
Submission : 2011-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27444
Submission : 2013-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-13
Pay. Date : 2014-03-12
DMF Number : 27600
Submission : 2014-02-26
Status : Active
Type : II
Certificate Number : CEP 2021-083 - Rev 01
Status : Valid
Issue Date : 2024-10-17
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-043 - Rev 01
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2815
Certificate Number : R0-CEP 2018-283 - Rev 00
Status : Valid
Issue Date : 2020-06-19
Type : Chemical
Substance Number : 2815
Certificate Number : R1-CEP 2016-051 - Rev 00
Status : Valid
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 2815
Certificate Number : R0-CEP 2018-093 - Rev 00
Status : Valid
Issue Date : 2020-04-09
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-271 - Rev 04
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2017-001 - Rev 01
Status : Valid
Issue Date : 2024-01-30
Type : Chemical
Substance Number : 2815
Certificate Number : CEP 2018-006 - Rev 01
Status : Valid
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 2815
Certificate Number : R1-CEP 2016-152 - Rev 00
Status : Valid
Issue Date : 2022-06-27
Type : Chemical
Substance Number : 2815
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Proceeds will support clinical development of DST1308, using a silica-based drug delivery platform, for Chronic Hepatitis B.
Lead Product(s): Entecavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: DST1308
Study Phase: UndisclosedProduct Type: Small molecule
Sponsor: DRW Venture Capital LLC
Deal Size: $10.8 million Upfront Cash: Undisclosed
Deal Type: Financing January 16, 2024
Lead Product(s) : Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : DRW Venture Capital LLC
Deal Size : $10.8 million
Deal Type : Financing
DelSiTech Closes EUR 10 Million Financing Round for Drug Delivery Technology
Details : Proceeds will support clinical development of DST1308, using a silica-based drug delivery platform, for Chronic Hepatitis B.
Brand Name : DST1308
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 16, 2024
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 Brand Name: AB-729
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Assembly Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Lead Product(s) : AB-729,Vebicorvir,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Assembly Biosciences
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : AB-729
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: AB-729
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Assembly Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Lead Product(s) : AB-729,Vebicorvir,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Assembly Biosciences
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : AB-729
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 20, 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 Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2022
Lead Product(s) : Vebicorvir,AB-729,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Assembly Biosciences Outlines Anticipated 2022 Pipeline Development Milestones
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.
Brand Name : ABI-H0731
Molecule Type : Small molecule
Upfront Cash : 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 Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Lead Product(s) : Vebicorvir,Entecavir,Pegylated-interferon Alpha
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Assembly Biosciences Abstracts Selected for Presentation at the Upcoming AASLD The Liver Meeting®
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.
Brand Name : ABI-H0731
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 01, 2021
Details:
The Phase 2 clinical study for ABI-H2158 is a multi-center, randomized, placebo-controlled trial in treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.
Lead Product(s): ABI-H2158,Entecavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H2158
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2021
Lead Product(s) : ABI-H2158,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Assembly Bio Announces Decision to Discontinue Clinical Development of ABI-H2158
Details : The Phase 2 clinical study for ABI-H2158 is a multi-center, randomized, placebo-controlled trial in treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.
Brand Name : ABI-H2158
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 01, 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 Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
Lead Product(s) : Vebicorvir,AB-729,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : BeiGene
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Trial will evaluate Assembly’s core inhibitor candidate, vebicorvir, with Arbutus’ RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy.
Brand Name : ABI-H0731
Molecule Type : Small molecule
Upfront Cash : 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 Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2021
Lead Product(s) : Vebicorvir,GalNAc-RNAi,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : ABI-H0731
Molecule Type : Small molecule
Upfront Cash : 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 Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Lead Product(s) : Vebicorvir,Tenofovir Alafenamide,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Multiple Abstracts Highlighting Assembly Biosciences’ Hepatitis B Core Inhibitor Development Pro...
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...
Brand Name : ABI-H0731
Molecule Type : Small molecule
Upfront Cash : 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 Brand Name: ABI-H0731
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2020
Lead Product(s) : Vebicorvir,Entecavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Clinical Data from Assembly Biosciences’ HBV Core Inhibitors Presented at The Digital Internatio...
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 infect...
Brand Name : ABI-H0731
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 28, 2020
RLD : No
TE Code : AB
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG
Approval Date : 2018-03-15
Application Number : 208721
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Approval Date : 2018-03-15
Application Number : 208721
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code :
Brand Name : BARACLUDE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 0.05MG/ML
Approval Date : 2005-03-29
Application Number : 21798
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Approval Date : 2017-05-11
Application Number : 206672
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG
Approval Date : 2016-12-06
Application Number : 206872
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG
Approval Date : 2019-03-26
Application Number : 206226
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Approval Date : 2020-05-20
Application Number : 211978
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG
Approval Date : 2014-08-26
Application Number : 202122
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 0.5MG
Approval Date : 2017-06-23
Application Number : 206745
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ENTECAVIR
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Approval Date : 2017-06-23
Application Number : 206745
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Syrup
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : ACTILLETS™ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.
Pharmacopoeia Ref : NA
Technical Specs : Bulk density: 0.80
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170, Taped Density: 0.80
Ingredient(s) : Starch
Dosage Form : Orodispersible Tablet
Grade : Oral
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