Drugs / Adefovir dipivoxil
Adefovir dipivoxil
also known as
ADV · Bis-POM PMEA · Preveon · 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine · Adefovir · Hepsera · ADF
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Hepsera | — | 2022-12-31 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | HEPSERA | — | 2004-08-19 – 2007-12-19 | fda.gov ↗ |
| Approved | EU (EMA) | Hepsera | — | 2003-03-06 | europa.eu ↗ |
| Approved | US (FDA) | HEPSERA | — | 2002-09-20 | fda.gov ↗ |
Trials 45 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01353742 Comparator | Feb → Apr 2011 | chronic hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT01844063 Background | Jul 2013 → Jan 2016 | liver failure | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 1/2 | NCT01718587 Comparator | Nov 2012 → May 2013 | cirrhosis of liver | General Hospital of Chinese Armed Police Forces | Unknown | No outcome recorded |
| Phase 1/2 | NCT00895596 Background | Mar 2004 → Aug 2006 | chronic hepatitis B virus infection | LG Life Sciences | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT02965859 Comparator | Dec 2012 → Dec 2018 | chronic hepatitis B virus infection | Guangzhou Yipinhong Pharmaceutical CO.,LTD | Unknown | No outcome recorded |
| Phase 2 | NCT00753467 Comparator | Sep 2008 → Aug 2009 | chronic hepatitis B virus infection | Huntington Medical Research Institutes | Unknown | No outcome recorded |
| Phase 2 | NCT00644761 Background | Feb 2004 → May 2005 | hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00000912 Background | ? → May 2000 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT01300234 Comparator | Mar 2011 → Oct 2012 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00672867 Comparator | Dec 2007 → Nov 2012 | — | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00371761 Comparator | Sep 2006 → Feb 2009 | chronic hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00116805 Comparator | Jun 2005 → May 2007 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00117676 Comparator | Feb 2005 → Apr 2007 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT00641082 Comparator | Feb 2008 → Mar 2012 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT00606099 Comparator | Nov 2007 → Nov 2009 | chronic hepatitis B virus infection | Novartis | Withdrawn | No outcome recorded |
| Phase 4 | NCT02598063 Comparator | Oct 2005 → Apr 2009 | chronic hepatitis B virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00307242 Comparator | Jun 2005 → Feb 2009 | chronic hepatitis B virus infection | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT00230477 Comparator | Apr 2003 → Aug 2007 | hepatitis B virus infection | University of Washington | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00973219 Comparator | Sep 2009 → Oct 2019 | chronic hepatitis B virus infection | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
Press releases naming this drug 44 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-08-19 | Gilead Sciences | Gilead Sciences Announces Notification of ANDA Filing for Hepsera(R) gilead.com ↗ |
| 2008-04-26 | Bristol-Myers Squibb | 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 ↗ |
| 2005-11-14 | Gilead Sciences | Five-Year Data Evaluating Long-Term Therapy with Hepsera(R) for Hepatitis B ''e'' Antigen-Negative Chronic Hepatitis B Presented at AASLD Annual Meeting gilead.com ↗ |
| 2005-06-29 | Gilead Sciences | Data Evaluating Long-Term Therapy with Hepsera for Hepatitis B ''e'' Antigen-Negative Chronic Hepatitis B Published in the New England Journal of Medicine gilead.com ↗ |
| 2004-11-02 | Gilead Sciences | Gilead Announces Long-Term Safety and Efficacy Data, Through 144 Weeks, for Hepsera in Patients With Chronic Hepatitis B gilead.com ↗ |
| 2004-04-15 | Gilead Sciences | New Data Support Hepsera's Long-Term Efficacy against Chronic Hepatitis B gilead.com ↗ |
| 2003-10-28 | Gilead Sciences | Gilead Announces 144-Week Data of Hepsera in Patients Co-Infected With HIV And Lamivudine-Resistant HBV gilead.com ↗ |
| 2003-05-16 | Gilead Sciences | Gilead Launches Web Site for Hepsera, Its Chronic Hepatitis B Drug gilead.com ↗ |
| 2003-04-09 | Gilead Sciences | 96-Week Data Show Hepsera Reduces Liver Damage and Improves Liver Function in More Than 70 Percent of Patients with Hepatitis B ``E'' Antigen-Negative Disease gilead.com ↗ |
| 2003-03-11 | Gilead Sciences | Gilead Sciences' Hepatitis B Drug Hepsera Approved for Marketing in European Union gilead.com ↗ |
| 2003-02-27 | Gilead Sciences | Results of Two Pivotal Studies of Gilead's Hepsera Published in the New England Journal of Medicine gilead.com ↗ |
| 2002-11-21 | Gilead Sciences | European CPMP Gives Positive Opinion On Hepsera, Gilead's Treatment for Chronic Hepatitis B; Recommendation Granted Eight Months After Filing gilead.com ↗ |
| 2002-11-04 | Gilead Sciences | New Data Demonstrate Antiviral Activity of Gilead's Hepsera in Patients with Lamivudine-Resistant Chronic Hepatitis B gilead.com ↗ |
| 2002-09-23 | Gilead Sciences | FDA Approves Gilead's Hepsera(TM) for the Treatment of Chronic Hepatitis B gilead.com ↗ |
| 2002-08-28 | Gilead Sciences | Hepsera Selected as U.S. Trade Name for Adefovir Dipivoxil gilead.com ↗ |
| 2002-08-06 | Gilead Sciences | FDA Advisory Committee Unanimously Supports Approval of Gilead's Adefovir Dipivoxil to Treat Chronic Hepatitis B gilead.com ↗ |
| 2002-08-05 | Gilead Sciences | Gilead Announces Posting of FDA Briefing Documents for August 6 Advisory Committee Review of Adefovir Dipivoxil for Chronic Hepatitis B gilead.com ↗ |
| 2002-04-29 | Gilead Sciences | Gilead and GlaxoSmithKline Announce International Licensing Agreement for Investigational Chronic Hepatitis B Drug Adefovir Dipivoxil gilead.com ↗ |
| 2002-04-19 | Gilead Sciences | Data From Study of Gilead's Adefovir Dipivoxil in Hepatitis B Patients With Lamivudine-Resistant Virus Presented At International Medical Meeting gilead.com ↗ |
| 2002-04-18 | Gilead Sciences | Gilead Announces Presentation of Data From Phase III Study of Adefovir Dipivoxil in Patients With Precore Mutant Chronic Hepatitis B gilead.com ↗ |
| 2002-04-18 | Gilead Sciences | 92-Week Data From Clinical Study of Gilead's Adefovir Dipivoxil in Patients Co-Infected With HIV and Lamivudine-Resistant HBV Presented At International Medical Meeting gilead.com ↗ |
| 2002-03-26 | Gilead Sciences | Gilead Submits Marketing Authorisation Application for Adefovir Dipivoxil 10 mg for Treatment of Chronic Hepatitis B; EU Application Follows Submission to FDA gilead.com ↗ |
| 2002-03-21 | Gilead Sciences | Gilead Submits New Drug Application to U.S. FDA for Adefovir Dipivoxil 10 mg for the Treatment of Chronic Hepatitis B gilead.com ↗ |
| 2002-03-12 | Gilead Sciences | Gilead Initiates Early Access Program for Adefovir Dipivoxil, Investigational Treatment for Chronic Hepatitis B Infection gilead.com ↗ |
| 2001-11-13 | Gilead Sciences | Gilead Announces Data from Studies of Adefovir Dipivoxil in Patients with Lamivudine-Resistant Chronic Hepatitis B Virus Infection gilead.com ↗ |
| 2001-11-12 | Gilead Sciences | Gilead Announces Data from Studies of Adefovir Dipivoxil Demonstrating Significant Improved Liver Function and Viral Load Reduction in Patients with Chronic Hepatitis B Virus Infection gilead.com ↗ |
| 2001-11-09 | Gilead Sciences | Gilead Announces Primary Endpoint Met in Phase III Study of Adefovir Dipivoxil 10 mg in Patients with Lamivudine-Resistant Chronic Hepatitis B Infection gilead.com ↗ |
| 2001-09-19 | Gilead Sciences | Gilead Sciences Announces Results From Phase III Study of Adefovir Dipivoxil In Precore Mutant Chronic Hepatitis B Virus Infection gilead.com ↗ |
| 2001-06-22 | Gilead Sciences | Gilead Achieves Primary Endpoint in Phase III Study of Adefovir Dipivoxil for Chronic Hepatitis B Virus Infection gilead.com ↗ |
| 2001-06-11 | Gilead Sciences | Gilead Sciences Initiates Phase I Study in China of Adefovir Dipivoxil, Investigational Compound for the Treatment of Chronic Hepatitis B Infection gilead.com ↗ |
| 2001-04-23 | Gilead Sciences | Gilead Sciences Announces Data from Studies of Adefovir Dipivoxil, Investigational Agent for the Treatment of Chronic Hepatitis B Infection gilead.com ↗ |
| 2000-12-11 | Gilead Sciences | Gilead Sciences Receives Approval to Initiate Clinical Trials in China for Adefovir Dipivoxil, an Investigational Compound for the Treatment of Chronic Hepatitis B Infection gilead.com ↗ |
| 2000-10-31 | Gilead Sciences | Gilead Sciences Announces Preliminary Results from Study of Adefovir Dipivoxil 10 mg for the Treatment of Patients Co-infected with HIV and Chronic Hepatitis B gilead.com ↗ |
| 2000-04-11 | Gilead Sciences | Gilead Presents Preliminary Clinical Data Describing Activity of Adefovir Dipivoxil Against Lamivudine-Resistant Hepatitis B Virus gilead.com ↗ |
| 2000-01-11 | Gilead Sciences | Gilead Begins Second Pivotal Phase III Trial of Once Daily Oral Hepatitis B Drug, Adefovir Dipivoxil 10 mg gilead.com ↗ |
| 1999-12-03 | Gilead Sciences | Gilead Sciences Announces Termination of Its U.S. Development Program for Adefovir Dipivoxil for HIV gilead.com ↗ |
| 1999-11-01 | Gilead Sciences | Gilead Sciences Announces Results of FDA Advisory Panel on Anti-HIV Agent, Adefovir Dipivoxil 60 Mg gilead.com ↗ |
| 1999-10-25 | Gilead Sciences | Gilead Sciences Completes European Marketing Authorisation Application For Anti-HIV Agent Adefovir Dipivoxil 60 Mg gilead.com ↗ |
| 1999-04-09 | Gilead Sciences | Gilead Presents Preliminary Clinical Data Demonstrating Activity of Adefovir Dipivoxil Against Lamivudine-Resistant Hepatitis B Virus gilead.com ↗ |
| 1999-03-17 | Gilead Sciences | Gilead Begins Multinational Phase III Trial of Hepatitis B Drug, Adefovir Dipivoxil gilead.com ↗ |
| 1998-09-23 | Gilead Sciences | Gilead Sciences Provides Update on PREVEON® Clinical Program for the Treatment of HIV gilead.com ↗ |
| 1998-04-28 | Gilead Sciences | Gilead Announces Adefovir Dipivoxil Reduces Hepatitis B Levels by More than 99 Percent in Chronically Infected Patients gilead.com ↗ |
| 1998-04-02 | Gilead Sciences | Gilead Broadens HIV Expanded Access Program for PREVEON® gilead.com ↗ |
| 1997-12-04 | Gilead Sciences | Gilead Sciences Announces Start of Expanded Access Program for PREVEON® gilead.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Adefovir Dipivoxil | “After 48 weeks of randomised double-blind comparison (trials NCT00117676 and NCT00116805) of tenofovir DF with adefovir dipivoxil, participants (positive or negative for HBeAg)...” PMID 23234725 ↗ Dec 201263“Investigational Product(s) Adefovir dipivoxil 10mg tablets will be supplied by GlaxoSmithKline and presented as a white to off white, round tablets, packaged in the bottle...” NCT01205165 ↗ “This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy.” NCT00230477 ↗ “Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)” NCT00857675 ↗ “tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B” NCT00117676 ↗ “Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection” NCT00158704 ↗ “Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg” NCT00895596 ↗ “A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al)” NCT01844063 ↗ “adefovir dipivoxil 10 mg per day (oral dose)” NCT01718587 ↗ “Adefovir Dipivoxil (ADV)” NCT00316719 ↗ |
| Known as | 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine | “Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients” NCT00002128 ↗1“9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) (Adefovir Dipivoxil)” NCT00000843 ↗ |
| Known as | Adefovir | “Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations” NCT00002398 ↗1“Adefovir dipivoxil (adefovir)” NCT00371761 ↗ |
| Known as | ADF | “Adefovir Dipivoxil (ADF) at Two Dose Levels” NCT00002184 ↗ |
| Known as | ADV | “The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs...” NCT00002426 ↗8“This study will investigate the safety and effectiveness of using adefovir dipivoxil (ADV), pegylated interferon (PEG-INF), and ribavirin (RBV) in patients triple-infected with...” NCT00051077 ↗ “Tenofovir disoproxil fumarate (TDF) and adefovir dipivoxil (ADV) are licensed for the treatment of HIV-1 and HBV infection, respectively, but both have in vivo and in vitro...” PMID 17058225 ↗ Nov 2006 “Patients in studies GS-US-174-0102 (HBeAg-) and GS-US-174-0103 (HBeAg+) were randomized 2:1 to receive TDF or adefovir dipivoxil (ADV) for 48 weeks followed by open-label TDF...” PMID 27658343 ↗ Sep 2016 “tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B” NCT00117676 ↗ “Arm A: APV plus saquinavir soft gel capsule (SQVsgc) plus abacavir (ABC) plus efavirenz (EFV) plus adefovir (ADV).” NCT00000912 ↗ “Adefovir dipivoxil (ADV) tablets” NCT01300234 ↗ “Adefovir Dipivoxil (ADV)” NCT00316719 ↗ “Adefovir Dipivoxil (ADV)” NCT00095121 ↗ |
| Known as | Bis-POM PMEA | “Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients” NCT00002128 ↗5“To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.” NCT00002161 ↗ “bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.” NCT00002346 ↗ “9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) (Adefovir Dipivoxil)” NCT00000843 ↗ “Preveon (Adefovir Dipivoxil; Bis-POM PMEA)” NCT00002419 ↗ “Preveon (Adefovir Dipivoxil; bis-POM PMEA)” NCT00002234 ↗ |
| Known as | Hepsera | “This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy.” NCT00230477 ↗1“Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection” NCT00158704 ↗ |
| Known as | Preveon | “Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations” NCT00002398 ↗2“Preveon (Adefovir Dipivoxil; bis-POM PMEA)” NCT00002234 ↗ “Preveon (Adefovir Dipivoxil; Bis-POM PMEA)” NCT00002419 ↗ |
| Action | Inhibit | “inhibits HBV replication” NCT00023153 ↗ |
| Modality | Small molecule | “Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B.” NCT00230477 ↗ |
| Route | Oral | “Oral Antiviral Compound” NCT00000843 ↗ |