Drugs / Adefovir

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed chronic hepatitis B virus infection 4 milestones
Filed US (FDA) — chronic hepatitis B virus infection —

“In late March, Gilead announced the submission of a New Drug Application (NDA) to the U.S. FDA for marketing approval of adefovir dipivoxil” gilead.com ↗

Filed EU (EMA) — chronic hepatitis B virus infection —

“Also in late March, Gilead announced the submission of a Marketing Authorisation Application (MAA) to the EMEA for adefovir dipivoxil.” gilead.com ↗

Filed Japan (PMDA) Hepsera chronic hepatitis B virus infection —

“In February, GSK received marketing approvals for Hepsera in Korea and Taiwan and submitted a Japanese New Drug Application (JNDA) for Hepsera in Japan.” gilead.com ↗

Filed Other Hepsera chronic hepatitis B virus infection —

“Regulatory filings for the drug also have been completed in Australia, Switzerland, Turkey and Canada” gilead.com ↗

Filed HIV infectious disease 2 milestones
Filed US (FDA) — HIV infectious disease 1999-06-29

“Gilead submitted a New Drug Application (NDA) for adefovir dipivoxil 60 mg for the potential treatment of HIV infection” gilead.com ↗

Filed EU (EMA) — HIV infectious disease —

“Gilead filed a Marketing Authorisation Application (MAA) for adefovir dipivoxil for HIV with the European Medicines Evaluation Agency (EMEA)” gilead.com ↗

“in October 1999 filed a marketing application through the centralized procedure of the European Medicines Agency” gilead.com ↗

Trials 28

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT03801759 Jul → Sep 2018 — Akebia Therapeutics Completed No outcome recorded
Phase 1 NCT00002115 — HIV infectious disease Gilead Sciences Completed No outcome recorded
Phase 1 NCT00002326 — HIV infectious disease Gilead Sciences Completed No outcome recorded
Phase 25 trials · 1 met primary
Phase 2 NCT00960518 Aug 2009 → Aug 2012 hepatitis B virus infection, hepatocellular carcinoma Tongji University Unknown No outcome recorded
Phase 2 NCT00230490 Jun 2005 → May 2007 chronic hepatitis B virus infection Bausch Health Americas, Inc. Terminated No outcome recorded
Phase 2 NCT00023309 Aug 2001 → Apr 2010 hepatitis B virus infection National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed Met primary
Phase 2 NCT00013702 Mar 2001 → Feb 2004 HIV infectious disease, hepatitis B virus infection National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00002219 — HIV infectious disease Gilead Sciences Unknown No outcome recorded
Phase 33 trials
Phase 3 NCT00605384 Aug 2008 → Feb 2009 chronic hepatitis B virus infection Bristol-Myers Squibb Terminated No outcome recorded Stop: Business
Phase 3 NCT00496158 Aug 2007 → ? chronic hepatitis B virus infection Pharmasset Terminated No outcome recorded
Phase 3 NCT00496002 Aug 2007 → ? chronic hepatitis B virus infection Pharmasset Terminated No outcome recorded
Phase 417 trials · 2 met primary · 2 missed
Phase 4 NCT02743260 Apr 2016 → Dec 2017 — University of Cologne Completed Met primary
Phase 4 NCT02560649 May 2015 → Aug 2016 chronic hepatitis B virus infection Ruijin Hospital Unknown No outcome recorded
Phase 4 NCT01928511 Jan 2014 → Dec 2018 chronic hepatitis B virus infection Seng Gee Lim Completed Met primary
Phase 4 NCT01834508 Mar 2013 → Jun 2016 chronic hepatitis B virus infection Nanfang Hospital, Southern Medical University Unknown No outcome recorded
Phase 4 NCT01799486 Feb 2013 cirrhosis of liver Lin Bingliang Unknown No outcome recorded
Phase 4 NCT01693679 Sep 2012 → Apr 2014 cirrhosis of liver Shao-quan Zhang Unknown No outcome recorded
Phase 4 NCT01595633 Mar 2012 → Feb 2014 chronic hepatitis B virus infection Yonsei University Unknown No outcome recorded
Phase 4 NCT01263002 Jun 2010 → Jan 2013 hepatocellular carcinoma Bukwang Pharmaceutical Completed No outcome recorded
Phase 4 NCT00922207 May 2010 → Sep 2014 chronic hepatitis B virus infection Hoffmann-La Roche Completed Missed primary
Phase 4 NCT01086085 Apr 2010 → Mar 2013 chronic hepatitis B virus infection Hoffmann-La Roche Completed Missed primary
Comparator or background therapy25 trials
Phase 1 NCT00513968 Comparator Jul 2007 → Apr 2010 chronic hepatitis B virus infection Genexine, Inc. Completed No outcome recorded
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 Missed primary
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

News releases announcing trial results or a regulatory action · 30

DateIssuerRelease
2010-08-19 Gilead Sciences Regulatory Gilead Sciences Announces Notification of ANDA Filing for Hepsera(R) gilead.com ↗
2008-12-03 Gilead Sciences Results Data Demonstrating Significant Efficacy of Viread(R) in Treating Chronic Hepatitis B Published in New England Journal of Medicine gilead.com ↗
Data also indicate that at week 48, Viread was superior to Hepsera in reducing HBV DNA levels to below 400 copies/mL and was comparable to Hepsera in achieving histological response.
2008-11-01 Gilead Sciences Results Gilead Announces Two-Year Data from Pivotal Phase III Studies Evaluating Viread(R) for Chronic Hepatitis B gilead.com ↗
The studies also show that all Hepsera-treated patients whose HBV levels were suppressed at week 48 maintained viral suppression after rolling over to Viread
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.
2007-06-25 Gilead Sciences Results Second Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint gilead.com ↗
The data show that Viread is non-inferior to the company's once-daily antiviral drug Hepsera(R) (adefovir dipivoxil) among patients with "e" antigen (HBeAg)-positive chronic hepatitis B.
2005-11-14 Gilead Sciences Results 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 ↗
In this analysis, which includes the first prospective set of liver biopsies following five years of oral antiviral therapy, treatment with Hepsera resulted in regression of liver fibrosis in 75 percent of patients.
2005-06-29 Gilead Sciences Results 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 ↗
Continued viral suppression and changes in laboratory markers of liver function were evaluated through three years.
2004-11-02 Gilead Sciences Results Gilead Announces Long-Term Safety and Efficacy Data, Through 144 Weeks, for Hepsera in Patients With Chronic Hepatitis B gilead.com ↗
This study suggests that in first-line treatment, Hepsera offers tolerability, continued inhibition of viral replication and normalization of liver enzymes for up to 144 weeks, with an increasing percent of patients achieving HBeAg seroconversion.
2004-04-15 Gilead Sciences Results New Data Support Hepsera's Long-Term Efficacy against Chronic Hepatitis B gilead.com ↗
In this study, patients treated with Hepsera showed progressive reductions in serum HBV DNA replication and sustained ALT normalization through 144 weeks of treatment.
2003-04-09 Gilead Sciences Results 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 ↗
In this study, more than 70 percent of patients treated with Hepsera showed persistent suppression of HBV DNA viral replication, continued histological improvements and sustained improvements in liver function through 96 weeks of treatment.
2003-03-11 Gilead Sciences Regulatory Gilead Sciences' Hepatitis B Drug Hepsera Approved for Marketing in European Union gilead.com ↗
2003-02-27 Gilead Sciences Results Results of Two Pivotal Studies of Gilead's Hepsera Published in the New England Journal of Medicine gilead.com ↗
In these studies, Hepsera slowed or even reversed signs of disease progression after a year in most patients, with good tolerability and no incidence of viral resistance.

All press releases naming this drug 45 releases

DateIssuerRelease

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 56 sources stand behind the page.

FieldValueCited 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 ↗

NCT00013702 ↗

NCT00718887 ↗

NCT01546116 ↗

Show 42 more sources

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)” NCT01373684 ↗
1

“adefovir (hepsera)” NCT01804387 ↗

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 2018
1

“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 2018
3

“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 ↗