Drugs / Adefovir
Adefovir
also known as
ADV · 9-(2-Phosphonylmethoxyethyl)Adenine · adefovir (hepsera) · Adefovir dipivoxil · PMEA · Adefovir (Hepasera) · Adefovir dipivoxil (Hepsera) · Hepsera
Trials 28 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 25 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00513968 Comparator | Jul 2007 → Apr 2010 | chronic hepatitis B virus infection | Genexine, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03491553 Background | Apr 2018 → Mar 2019 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01943799 Background | Sep 2013 → Sep 2014 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01706575 Background | Jan → Sep 2013 | chronic hepatitis B virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02366208 Background | May 2011 → Jun 2013 | chronic hepatitis B virus infection | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT03236584 Comparator | Sep 2015 → Mar 2018 | — | Uijeongbu St. Mary Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02366247 Background | Aug 2013 → Dec 2015 | chronic hepatitis B virus infection | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT01192854 Comparator | Feb 2010 → May 2011 | chronic hepatitis B virus infection | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00410202 Comparator | Mar 2008 → Jan 2011 | chronic hepatitis B virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00640588 Comparator | Mar 2008 → Dec 2009 | chronic hepatitis B virus infection | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00096785 Comparator | Dec 2004 → Jan 2006 | hepatitis B virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00065507 Comparator | Aug 2003 → Oct 2008 | chronic hepatitis B virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT03084250 Comparator | Mar 2017 → Apr 2023 | hepatitis B virus infection | Shanghai Nanhui Nanhua Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02482272 Background | May 2015 → Jan 2017 | chronic hepatitis B virus infection | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01829685 Comparator | Mar 2013 → Jun 2016 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01732367 Comparator | Nov 2012 → Mar 2016 | chronic hepatitis B virus infection | Keimyung University Dongsan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01491295 Comparator | Sep 2012 → Dec 2019 | chronic hepatitis B virus infection | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT01597934 Comparator | Aug 2012 → May 2014 | chronic hepatitis B virus infection | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT01373684 Comparator | May 2012 → Oct 2019 | chronic hepatitis B virus infection | Foundation for Liver Research | Completed | No outcome recorded |
| Phase 4 | NCT01529255 Comparator | Aug 2011 → Aug 2015 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01804387 Comparator | May 2011 → Dec 2013 | chronic hepatitis B virus infection | Korea University | Unknown | No outcome recorded |
| Phase 4 | NCT01341743 Comparator | Dec 2010 → Jun 2014 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01023217 Background | Nov 2009 → Jul 2012 | chronic hepatitis B virus infection | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00798460 Comparator | Dec 2008 → Jun 2010 | chronic hepatitis B virus infection | Inje University | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01139203 Comparator | Aug 2009 → Dec 2012 | hepatitis B virus infection | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
Press releases naming this drug 41 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 ↗ |
| 1998-04-28 | Gilead Sciences | Gilead Announces Adefovir Dipivoxil Reduces Hepatitis B Levels by More than 99 Percent in Chronically Infected Patients gilead.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Adefovir | “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 ↗52“Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)” NCT01943799 ↗ “Maintaining LAM/LdT+ADV combination Lamivudine 100mg / Telbivudine 600mg +Adefovir 10mg” NCT01597934 ↗ “Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.” NCT01706575 ↗ “Adefovir 10mg QD for 36 months (adjust dosage according to renal function)” NCT01491295 ↗ “if HBV DNA breakthrough, add on oral adefovir 10mg daily” NCT01529255 ↗ “Adefovir (Hepsera®)” NCT03491553 ↗ “Adefovir (Hepsera)” NCT01373684 ↗ |
| Known as | 9-(2-Phosphonylmethoxyethyl)Adenine | “A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.” NCT00002115 ↗1“Combination Zidovudine (AZT) and 9-(2-Phosphonylmethoxyethyl)Adenine (PMEA; Adefovir) Treatment” NCT00002326 ↗ |
| Known as | Adefovir (Hepasera) | “Adefovir (Hepasera)” NCT01546116 ↗ |
| Known as | adefovir (hepsera) | “adefovir (hepsera)” NCT01804387 ↗1“Adefovir (Hepsera)” NCT01373684 ↗ |
| Known as | Adefovir dipivoxil | “BACKGROUND: The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable...” PMID 29329305 ↗ Jan 20181“Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.” NCT00513968 ↗ |
| Known as | Adefovir dipivoxil (Hepsera) | “Adefovir dipivoxil (Hepsera)” NCT01023217 ↗ |
| Known as | ADV | “BACKGROUND: The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable...” PMID 29329305 ↗ Jan 20183“Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections.” PMID 32460460 ↗ May 2020 “The patients switched therapy to entecavir (ETV) with or without adefovir (ADV) for 104 weeks.” PMID 33500704 ↗ Jan 2021 “Adefovir (ADV)” NCT00065507 ↗ |
| Known as | Hepsera | “Adefovir (Hepsera®)” NCT03491553 ↗ |
| Known as | PMEA | “A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.” NCT00002115 ↗1“Combination Zidovudine (AZT) and 9-(2-Phosphonylmethoxyethyl)Adenine (PMEA; Adefovir) Treatment” NCT00002326 ↗ |
| Action | Inhibit | “Adefovir inhibits HBV by interfering with replication of the virus's genetic material” NCT00013702 ↗ |
| Route | Intravenous | “administered daily by intravenous (IV) and/or subcutaneous (SC) injection” NCT00002115 ↗ |
| Route | Subcutaneous | “administered daily by intravenous (IV) and/or subcutaneous (SC) injection” NCT00002115 ↗ |