Entecavir
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis B virus infection 2 milestones | |||||
| Filed | EU (EMA) | — | chronic hepatitis B virus infection | — | “a marketing authorization application (MAA) for entecavir with the European Medicines Evaluation Agency (EMEA)” bms.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis B virus infection | — | “Bristol-Myers Squibb recently submitted a new drug application (NDA) for entecavir to the U.S. Food and Drug Administration (FDA)” bms.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | BARACLUDE | — | 2007-02-23 – 2014-03-20 | fda.gov ↗ |
| Approved | EU (EMA) | Baraclude | — | 2006-06-26 | europa.eu ↗ |
| Approved | US (FDA) | BARACLUDE | — | 2005-03-29 | fda.gov ↗ |
Trials 120 · started per year
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2024-06-05 | Aligos Therapeutics | Results Aligos Therapeutics Presents Positive Data at the EASL Congress 2024 aligos.com ↗
Extended Treatment of HBeAg+ CHB Subjects with the Capsid Assembly Modulator ALG-000184 with or without Entecavir is Associated with Reductions in Viral Markers and Favorable Anti-HBeAb trends |
| 2024-05-22 | Aligos Therapeutics | Results Aligos Therapeutics Announces Six Abstracts Accepted for Presentation at EASL 2024 aligos.com ↗
Extended Treatment of HBeAg+ CHB Subjects with the Capsid Assembly Modulator ALG-000184 with or without Entecavir is Associated with Reductions in Viral Markers and Favorable Anti-HBeAb trends |
| 2023-06-26 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Poster Presentation of Phase II Study of ASC42 FXR Agonist for Functional Cure of Chronic Hepatitis B at EASL CONGRESS 2023 ascletis.com ↗
In total, 122, 119, and 107 adverse events (AEs) were reported in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively, and most AEs (94.3%) were mild (grade 1) or moderate (grade 2) in severity. |
| 2023-06-21 | Assembly Biosciences | Results Assembly Biosciences Presents New Data Highlighting Entry Inhibitor and Core Inhibitor Programs at EASL’s International Liver Congress™ 2023 assemblybio.com ↗
The first-generation core inhibitor candidate, VBR, was evaluated in a Phase 2 study in combination with entecavir (ETV) and pegylated interferon alpha (Peg-IFNα) in patients with hepatitis B e antigen positive cHBV infection. |
| 2023-02-16 | Aligos Therapeutics | Results Aligos Therapeutics Presents Program Updates at the 32nd Conference of the Asian Pacific Association for the Study of the Liver aligos.com ↗
These data demonstrate that ALG-000184 has best-in-class properties and a potential role in combination therapeutic regimens for CHB. |
| 2023-02-14 | Aligos Therapeutics | Results Aligos Therapeutics to Present Program Updates at the 32nd Conference of the Asian Pacific Association for the Study of the Liver aligos.com ↗
ALG-000184, a Capsid Assembly Modulator, Demonstrates Superior Antiviral Activity in Combination with Entecavir Compared to Entecavir in HBeAg Positive Subjects with Chronic Hepatitis B infection |
| 2022-06-22 | Assembly Biosciences | Results Assembly Biosciences Presents New Data Highlighting Clinical Progress of Core Inhibitor Programs at EASL’s International Liver Congress™ 2022 assemblybio.com ↗ |
| 2022-06-08 | Assembly Biosciences | Results Assembly Biosciences to Highlight Data from HBV Core Inhibitor Programs at EASL’s International Liver Congress™ 2022 assemblybio.com ↗
Greater sequence diversity during early hepatitis B virus decline on vebicorvir plus entecavir is associated with a lower level of virus rebound following switch to entecavir monotherapy |
| 2019-11-11 | Assembly Biosciences | Results Data for Assembly Biosciences’ First and Second Generation HBV Core Inhibitors in Development for the Treatment of Chronic Hepatitis B Highlighted in Late-Breaker Poster Session at AASLD 2019 assemblybio.com ↗
Final Week 24 results from HBeAg-positive patients in Study 202 (n=25) demonstrated faster and deeper HBV DNA declines in patients receiving 731+entecavir (ETV) than those receiving ETV alone. |
| 2019-10-16 | Assembly Biosciences | Results Safety and Antiviral Activity of Assembly Biosciences’ First and Second Generation Core Inhibitor Candidates In the Treatment of Chronic Hepatitis B to be Featured in a Late Breaking Session at AASLD assemblybio.com ↗
In Study 202 (Rx naïve patients), greater mean log10 declines in HBV DNA (5.27 vs 3.99; p=0.017) and RNA (2.34 vs 0.61; p<0.001) were achieved with 731+Nrtl (entecavir) versus entecavir alone. |
| 2019-04-13 | Assembly Biosciences | Results Assembly Biosciences Presents Interim Data from Two Phase 2a Studies of ABI-H0731 in HBV-Infected Subjects in a Late-Breaker Oral Session at EASL 2019 assemblybio.com ↗
The combination of 731 + entecavir (ETV) reduced both HBV DNA and HBV RNA significantly faster and deeper compared to ETV monotherapy as early as week 2. |
| 2017-12-20 | Replicor Inc. | Results Replicor announces publication of its latest pre-clinical hepatitis B study: replicor.com ↗
REP 2139 and TDF/ETV combine synergistically to establish control of cccDNA in the liver |
| 2017-04-20 | Yung Shin Pharm. Ind. Co., Ltd. | Regulatory 永信B型肝炎用藥產品 Entecavir Tablet於2017年2月 獲日本厚生省核准上市 com.tw ↗
永信原料製劑垂直整合之慢性B型肝炎用藥 - Entecavir Tablet於 2月15日順利獲得日本厚生省核准，永信為第一批取得許可證之學名藥廠！ |
| 2016-04-13 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Presents Promising ARC-520 Hepatitis B Data at The International Liver Congress™ 2016 arrowheadpharma.com ↗
ARC-520 and entecavir produced rapid HBV DNA suppression |
| 2015-12-01 | Replicor Inc. | Results Replicor to present pre-clinical and clinical data on REP 2139-Ca based combination therapy in chronic HBV / HDV co-infection at HEPDART 2015 replicor.com ↗
Poster #114 will present the preclinical assessment of interferon-free combination therapy with REP 2139-Ca and tenofovir disoproxil fumarate (TDF) and entecavir (ETV) to establish control of HBV infection in the liver using the duck model of HBV infection. |
| 2015-04-10 | Replicor Inc. | Results Replicor to Present at the 2015 Lancet Viral Hepatitis Conference replicor.com ↗
These clinical trials indicated that REP 2139-Ca appears to significantly increase the 12-month SVR rate achieved compared to existing therapies. |
| 2013-11-04 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Data Suggesting ARC-520 Induces Therapeutic Flare in Chronic Hepatitis B arrowheadpharma.com ↗
The data presented indicate that treatment with ARC-520 in combination with entecavir appears to be additive and possibly synergistic. |
| 2013-04-26 | Replicor Inc. | Results Replicor presents updated clinical efficacy results in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139-ca and new clinical data in patients receiving this combination treatment while currently on entecavir (triple combination therapy). replicor.com ↗
Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment. |
| 2012-10-15 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Labeling Update for BARACLUDE® (entecavir) (0.5 mg/1 mg Tablets) to Include Data on African Americans and Liver Transplant Recipients with Chronic Hepatitis B in Adult Patients bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the labeling for BARACLUDE ® (entecavir) to include data on African Americans and liver transplant recipients with chronic hepatitis B infection. |
| 2011-11-08 | Bristol-Myers Squibb | Results Phase IIIb Comparison of BARACLUDE® (entecavir) Monotherapy Versus BARACLUDE Plus Tenofovir Combination Shows No Statistical Difference Between Study Arms bms.com ↗
Overall, both study arms had similar safety profiles. |
| 2010-10-18 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves BARACLUDE® (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of BARACLUDE for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease. |
| 2008-11-02 | Bristol-Myers Squibb | Results New Data Suggest Long-Term Treatment with BARACLUDE(R) (entecavir) May Reduce Liver Damage Caused by Chronic Hepatitis B bms.com ↗
Of the 57 patients, 96 percent (55/57) experienced improvement in liver histology (improvement in how the liver tissue looks under a microscope). |
| 2008-10-29 | Bristol-Myers Squibb | Results Use of Investigational Agent Entecavir Demonstrated Statistically Significant Improvement in Liver Histology and Viral Suppression Compared to Lamivudine in Chronically Infected Hepatitis B E-Antigen (HBeAg) Positive Patients bms.com ↗
At Week 48, histologic improvement was observed in 72 percent of patients taking entecavir compared to 62 percent of patients receiving lamivudine using the Knodell necroinflammatory score analysis. |
| 2008-04-26 | Bristol-Myers Squibb | Results BARACLUDE® (Entecavir) Treatment Resulted In Greater Viral Load Suppression Compared to Adefovir at 96 Weeks In Antiviral-Naive Adult Chronic Hepatitis B E-Antigen Positive Patients bms.com ↗
Of the 49 patients who remained in the study at 96 weeks, 79 percent (n=23/29) of BARACLUDE-treated patients and 50 percent (n=10/20) of adefovir-treated patients achieved undetectable viral load. |
| 2008-03-24 | Bristol-Myers Squibb | Results BARACLUDE® (entecavir) Data Continue to Demonstrate Low Incidence of Resistance Through Five Years of Treatment in Nucleoside-naive Chronic Hepatitis B Patients bms.com ↗
New BARACLUDE® (entecavir) data presented today demonstrated a continued low incidence of resistance in nucleoside-naive patients through five years of treatment. |
All press releases naming this drug 29 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 256 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Entecavir | “A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an...” NCT02850848 ↗243“Patients will be on their existing nucleosid(t)e analogue therapy comprising lamivudine 100mg daily, adefovir 10mg daily, entecavir 0.5mg or 1.0mg daily or tenofovir 300mg...” NCT01928511 ↗ “Participants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved...” NCT03780543 ↗ “First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally,...” NCT06323681 ↗ “NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.” NCT05763576 ↗ “Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)” NCT01943799 ↗ “Oral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks” NCT05182463 ↗ “Patients will continue ongoing nucleos(t)ide analogue (Entecavir or Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide Fumarate) therapy for 48 weeks” NCT05256823 ↗ “Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.” NCT07809165 ↗ “Efficacy and Safety of Switching from Entecavir to Tenofovir Alafenamide in Chronic Hepatitis B: A Multicenter Randomized Trial in Korea.” PMID 42015653 ↗ Apr 2026 “The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.” NCT04942886 ↗ |
| Known as | Baraclude | “This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in...” NCT01341106 ↗7“All subjects were orally administered once a day at night ： Baraclude® 0.5 mg QD，60weeks” NCT05484466 ↗ “0.5mg Baraclude (entecavir) QD for 6 months after cessation of TDF.” NCT03308890 ↗ “Entecavir (Baraclude) 0.5 mg/day po at week 1-4” NCT00921180 ↗ “Entecavir (Baraclude)0.5 mg/day po at week 1-4” NCT00917761 ↗ “Entecavir (Baraclude®)” NCT03491553 ↗ |
| Known as | Baraclude(Entecavir) | “Baraclude(Entecavir)” NCT01641536 ↗ |
| Known as | Entecavir (Baraclude) | “Entecavir (Baraclude)” NCT01373684 ↗1“Entecavir (Baraclude)” NCT01023217 ↗ |
| Known as | Entecavir (ETV) | “Entecavir (ETV)” NCT03576066 ↗ |
| Known as | Entecavir (ETV) - brand name Baraclude | “Entecavir (ETV) - brand name Baraclude” NCT03780543 ↗ |
| Known as | Entecavir 0.5mg tablets (Bristol-Myers Squibb) | “Entecavir 0.5mg tablets (Bristol-Myers Squibb)” NCT01894269 ↗ |
| Known as | Entecavir 1.0mg - Braclude | “Entecavir 1.0mg - Braclude” NCT01594905 ↗ |
| Known as | Entecavir Dispersible Tablets | “Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.” NCT06990776 ↗1“Entecavir Dispersible Tablets, Inhibit viral replication;” NCT06566248 ↗ |
| Known as | entecavir hydrate | “The study aimed to evaluate the efficacy and safety of tenofovir disoproxil fumarate (TDF) and entecavir hydrate (ETV) in nucleos(t)ide analog (NA)-naïve Japanese chronic...” PMID 28374496 ↗ May 2017 |
| Known as | Entigin | “A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an...” NCT02850848 ↗ |
| Known as | ETV | “The purpose of our study is to conduct a multicenter, prospective, randomized study comparing the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in...” NCT01580202 ↗32“Another potent anti-viral drug, entecavir (ETV), on the other hand, reduces HBV replication in most patients, but causes improvement of liver histology in only 30%, possibly...” NCT01589952 ↗ “First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally,...” NCT06323681 ↗ “NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.” NCT05763576 ↗ “Oral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks” NCT05182463 ↗ “we evaluated the antiviral efficacy and safety of entecavir (ETV) plus tenofovir (TDF) combination therapy in multidrug-resistant (MDR) CHB patients.” PMID 26781724 ↗ Feb 2016 “we conducted a randomized controlled trial in which CHB patients with spontaneous SAE were randomized to receive lamivudine (LVD) or entecavir (ETV)” PMID 28671553 ↗ 2018 “Tenofovir alafenamide (TAF) has emerged as a safe and effective alternative to entecavir (ETV) in the management of chronic hepatitis B (CHB).” PMID 42015653 ↗ Apr 2026 “Participants will also receive background treatment with NA (either tenofovir disoproxil, tenofovir alafenamide [TAF] or entecavir [ETV]).” NCT05275023 ↗ “Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result in faster and greater antiviral activity” NCT01597934 ↗ “Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert” NCT04454567 ↗ |
| Known as | Generic/Brand name: Entecavir/Baraclude(TM) | “Generic/Brand name: Entecavir/Baraclude(TM)” NCT01220596 ↗ |
| Known as | RunZhong | “Patients in the ETV group received ETV tablets (RunZhong, CHIATAI TIANQING, China) 0.5 mg/d orally starting from 2-4 weeks before surgery;” NCT04032860 ↗ |
| Action | Inhibit | “which has been proved effective in suppressing viral replication” NCT00663182 ↗ |
| Modality | Small molecule | “Entecavir, a carbocyclic deoxyguanosine analog” NCT00597259 ↗ |
| Route | Oral | “Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized” NCT00065507 ↗ |