Drugs / Fosamprenavir
Fosamprenavir
also known as
FPV · GW433908 · Lexiva · fAPV · FOS · fos-APV · fosamprenavir (Lexiva, FPV, Telzir) · fosamprenavir calcium · +7 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Telzir | — | 2025-11-21 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | LEXIVA | — | 2007-10-12 – 2012-04-27 | fda.gov ↗ |
| Approved | EU (EMA) | Telzir | — | 2004-07-12 | europa.eu ↗ |
| Approved | US (FDA) | LEXIVA | — | 2003-10-20 | fda.gov ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT01290211 | Apr → Jun 2011 | — | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01140412 | Jul → Oct 2010 | — | ViiV Healthcare | Terminated | No outcome recorded |
| Phase 1 | NCT00977301 | Nov 2009 → Aug 2010 | HIV infectious disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00817765 | Jan → Jul 2009 | HIV infectious disease, fungal infectious disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00775125 | Jun → Oct 2008 | HIV infectious disease, hepatitis C virus infection | Tibotec BVBA | Completed | No outcome recorded |
| Phase 1 | NCT00877591 | Apr 2008 → Apr 2013 | HIV infectious disease, opiate dependence | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT00481182 | Feb 2005 → ? | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00307502 | Jan 2005 → Dec 2009 | HIV infectious disease | Germans Trias i Pujol Hospital | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT06704100 | Oct 2027 → Dec 2028 expected | gastroesophageal reflux disease | Medical College of Wisconsin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04383262 | Oct 2026 → Jul 2027 expected | gastroesophageal reflux disease | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 2 | NCT00122603 | Dec 2005 → Aug 2007 | HIV infectious disease | French National Agency for Research on AIDS and Viral Hepatitis | Completed | No outcome recorded |
| Phase 2 | NCT00089583 | Jul 2004 → Mar 2011 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00071760 | Oct 2003 → Jul 2011 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00040664 | Jul 2002 → Oct 2008 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00027339 | ? → Jun 2005 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00624195 | Mar 2007 → Feb 2012 | HIV infectious disease | University of California, San Diego | Completed | Missed primary |
| Phase 311 trials · 3 met primary | ||||||
| Phase 3 | NCT00727597 | Jul 2008 → Aug 2010 | HIV infectious disease | Georgetown University | Completed | No outcome recorded |
| Phase 3 | NCT00450580 | Mar 2007 → Aug 2008 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT00363142 | May 2006 → Jun 2008 | HIV infectious disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00144833 | Mar 2005 → ? | — | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT00094523 | Dec 2004 → Jun 2007 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT00085943 | May 2004 → ? | HIV infectious disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00043888 | Jan 2002 → May 2003 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00296504 | Nov 2001 → Oct 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT00025727 | May 2001 → ? | HIV infectious disease | GlaxoSmithKline | Unknown | No outcome recorded |
| Phase 3 | NCT00009061 | Nov 2000 → ? | HIV infectious disease | Glaxo Wellcome | Unknown | No outcome recorded |
| Phase 3 | NCT00008554 | Nov 2000 → ? | HIV infectious disease | Glaxo Wellcome | Unknown | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT02513147 | Jun 2015 → Nov 2016 | — | Hospital Universitari Vall d'Hebron Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT01222611 | Mar 2011 → Jun 2013 | HIV infectious disease, hepatitis C virus infection | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT01010399 | Sep 2009 → Nov 2010 | HIV infectious disease, hypertriglyceridemia | Felizarta, Franco, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00335270 | Mar 2006 → Dec 2007 | HIV infectious disease | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00148785 | Jul 2005 → Jan 2007 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00240552 | Jul 2003 → Aug 2005 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00884793 | Sep 2008 → Dec 2009 | HIV infectious disease | University of California, San Francisco | Completed | No outcome recorded |
| — | NCT00028366 | ? → Jul 2005 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT01209065 Background | Sep → Nov 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00764465 Comparator | Oct → Dec 2008 | — | Garden State Infectious Disease Associates, PA | Completed | No outcome recorded |
| Phase 2/3 | NCT01923311 Background | Aug 2013 → Nov 2017 | AIDS | Gilead Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT02616783 Comparator | Dec 2015 → Feb 2018 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02605954 Comparator | Nov 2015 → Jun 2017 | HIV infectious disease | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT01475838 Comparator | Nov 2011 → Nov 2013 | AIDS | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01252940 Background | Nov 2010 → Jan 2012 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00708162 Background | Jul 2008 → Dec 2010 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 4 | NCT01637259 Comparator | Jun 2012 → Dec 2015 | HIV infectious disease, proteinuria | Kirby Institute | Completed | No outcome recorded |
| Phase 4 | NCT00242216 Comparator | May 2004 → Mar 2010 | HIV infectious disease | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| — | NCT00802074 Comparator | Dec 2008 → Mar 2009 | — | Garden State Infectious Disease Associates, PA | Completed | No outcome recorded |
| — | NCT00614991 Comparator | Jan → Mar 2008 | — | Garden State Infectious Disease Associates, PA | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2016-07-27 | Lupin Limited | Regulatory Lupin Receives Tentative Approval for Generic Lexiva® Tablets, 700 mg from US FDA lupin.com ↗
Lupin Pharmaceuticals Inc. has received tentative approval from the United States Food and Drug Administration (FDA) to market a generic equivalent of ViiV Healthcare’s (ViiV) Lexiva® Tablets, 700 mg (Fosamprenavir Calcium Tablets, 700 mg). |
| 2006-09-28 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals and GlaxoSmithKline Announce Virologic and Drug Resistance Results from Protease Inhibitor Study vrtx.com ↗
Data presented today show low rates of virologic failure and antiviral drug resistance with the HIV protease inhibitor LEXIVA boosted with ritonavir (LEXIVA/r). |
| 2006-08-17 | Vertex Pharmaceuticals Incorporated | Results Head-to-Head Study Comparing LEXIVA(R) (fosamprenavir calcium) to Kaletra Presented at IAC 2006 and Published in The Lancet vrtx.com ↗
This month, The Lancet published results of a study showing that HIV regimens using LEXIVA (Telzir) Tablets+ritonavir and Kaletra (lopinavir/ritonavir) Capsules both given twice-daily had comparable (non-inferior) efficacy and tolerability in adults who had no previous exposure to HIV medicines. |
| 2006-05-16 | Vertex Pharmaceuticals Incorporated | Results GlaxoSmithKline and Vertex Pharmaceuticals Announce Preliminary 48-Week Results from Head-to-Head Clinical Study of HIV Protease Inhibitors Lexiva (Telzir) and Kaletra in Treatment-naive Patients with HIV vrtx.com ↗
Based on these results from this study, researchers have concluded that Lexiva appears to be comparable to Kaletra and has met the primary endpoints of this non-inferiority trial. |
| 2005-11-18 | Vertex Pharmaceuticals Incorporated | Regulatory FDA Approves Updated Labeling for LEXIVA vrtx.com ↗
GlaxoSmithKline (NYSE: GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved GSK's application to add clinical data to the prescribing information for LEXIVA(R) (fosamprenavir calcium), an HIV protease inhibitor (PI). |
| 2005-11-18 | Vertex Pharmaceuticals Incorporated | Regulatory FDA Approves Updated Labeling for LEXIVA vrtx.com ↗
GlaxoSmithKline (NYSE: GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved GSK's application to add clinical data to the prescribing information for LEXIVA® (fosamprenavir calcium), an HIV protease inhibitor (PI). |
| 2005-07-26 | Vertex Pharmaceuticals Incorporated | Results Study Results Presented on Pharmacokinetics of Once-Daily HIV Combination Therapy vrtx.com ↗
Results showed that plasma levels of all four drugs remained within previously described pharmacokinetic parameters, supporting the potential for this combination to be a useful once-daily regimen for the treatment of HIV infection. |
| 2005-07-26 | Vertex Pharmaceuticals Incorporated | Results Long-Term Safety Data of Lexiva/r in HIV Patients Co-Infected with Hepatitis vrtx.com ↗
"It is encouraging that the liver enzymes remained stable in co-infected patients," said Mark Shaefer, Pharm. D., Acting Vice President, HIV, Infectious Disease Medicine Development Center at GlaxoSmithKline. |
| 2005-04-29 | Vertex Pharmaceuticals Incorporated | Results New Pharmacokinetic Data On Taking Lexiva Simultaneously With Nexium vrtx.com ↗
When these agents were simultaneously co-administered there was no effect on amprenavir steady-state plasma levels. |
| 2005-04-29 | Vertex Pharmaceuticals Incorporated | Results New Pharmacokinetic Data on Co-Administration of the PI LEXIVA/r With the NRTI Tenofovir vrtx.com ↗
There also were no significant safety findings when combining LEXIVA/r with TDF in the 35 healthy male volunteers studied. |
| 2004-12-15 | Vertex Pharmaceuticals Incorporated | Results Viral Suppression of Once-Daily LEXIVA Plus Ritonavir Sustained Over 120 Weeks in ART-naive Subjects, According to Study Presented at DART vrtx.com ↗
The protease inhibitor (PI) LEXIVA(R) (fosamprenavir calcium) plus ritonavir (LEXIVA/r) dosed once daily (QD) demonstrated sustained viral suppression and safety over 120 weeks, according to data presented here today at the Frontiers in Drug Development for Antiretroviral Therapies (DART) conference. |
| 2004-07-16 | Vertex Pharmaceuticals Incorporated | Regulatory GlaxoSmithKline and Vertex Receive European Approval for Telzir(R), a New Protease Inhibitor for the Treatment of HIV vrtx.com ↗
GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that they have received marketing approval from the European Commission for Telzir(R) (fosamprenavir) for the treatment of HIV infection in adults in combination with other anti-HIV medications. |
| 2004-07-13 | Vertex Pharmaceuticals Incorporated | Results Studies of Sustained Efficacy/Tolerability of LEXIVA After 96 Weeks of Treatment Presented at IAC vrtx.com ↗
In this analysis, viral suppression and immunologic improvements were sustained through 96 weeks of treatment with LEXIVA and LEXIVA/r. |
| 2004-07-12 | Vertex Pharmaceuticals Incorporated | Results Study Evaluates Effectiveness of LEXIVA/ritonavir and Lopinavir/ritonavir in Protease Inhibitor (PI)- Experienced Patients 48-Week Data Presented at IAC vrtx.com ↗
HIV treatment regimens containing the protease inhibitor (PI) LEXIVA(R) (fosamprenavir calcium) dosed with ritonavir (LEXIVA/r) or lopinavir (LPV) and ritonavir (LPV/r) were effective in suppressing HIV in patients who had failed prior PI-containing regimens, according to information presented here today at the International AIDS Conference (IAC). |
| 2004-07-08 | Vertex Pharmaceuticals Incorporated | Results 48-Week Efficacy Comparison of Lexiva/Ritonavir QD vs. Nelfinavir BID in Therapy-Naive HIV+ Patients: Results Published in AIDS vrtx.com ↗
Both regimens were generally well-tolerated, according to the study's authors. |
| 2004-03-25 | Vertex Pharmaceuticals Incorporated | Regulatory GSK and Vertex Pharmaceuticals Receive European CPMP Positive Opinion for Telzir(R) vrtx.com ↗
GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that they have received a positive opinion from the European Committee for Proprietary Medicinal Products (CPMP) for Telzir(R) (fosamprenavir) for the treatment of HIV infection in adults in combination with other antiretroviral medications. |
| 2004-01-20 | Vertex Pharmaceuticals Incorporated | Results Phase III, 48-Week NEAT Study Results Comparing LEXIVA(TM) to Nelfinavir Published in the Journal of Acquired Immune Deficiency Syndrome (JAIDS) vrtx.com ↗
In the trial, 66 percent of 166 HIV+ patients (n=109) achieved a viral load (vRNA) 400 copies/mL with LEXIVA, compared to 51 percent of 83 patients (n=42) taking nelfinavir. |
All press releases naming this drug 18 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fos-amprenavir | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗43“Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir” NCT02302547 ↗ “(Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir,if the 2 NRTIs are abacavir + Lamivudine” NCT02513147 ↗ “Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir.” NCT01252940 ↗ “PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.” NCT00884793 ↗ “For these reasons, RTV enhanced indinavir (IDV) and fos-amprenavir (fos-APV) combinations appear promising for salvage therapy” NCT00148785 ↗ “allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)” NCT01475838 ↗ “Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)” NCT00727597 ↗ “The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir” NCT00708162 ↗ “Fosamprenavir suspension or tablet bid” NCT00089583 ↗ “fosamprenavir (FPV; Lexiva®) + RTV” NCT02616783 ↗ |
| Known as | fAPV | “steady-state darunavir/ritonavir (DRV/rtv) 600/100 mg b.i.d. (twice a day) or fosamprenavir/ritonavir (fAPV/rtv) 700/100 mg b.i.d.” NCT00775125 ↗1“fos-amprenavir (fAPV) boosted with either of two doses of ritonavir (RTV)” NCT00335270 ↗ |
| Known as | FOS | “The objective of this study is to evaluate the efficacy and safety of fosamprenavir (FOS), administered orally for improving symptoms of laryngopharyngeal reflux (LPR).” NCT04383262 ↗ |
| Known as | fos-APV | “For these reasons, RTV enhanced indinavir (IDV) and fos-amprenavir (fos-APV) combinations appear promising for salvage therapy” NCT00148785 ↗ |
| Known as | fosamprenavir (Lexiva, FPV, Telzir) | “fosamprenavir (Lexiva, FPV, Telzir)” NCT00884793 ↗ |
| Known as | fosamprenavir calcium | “Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day” NCT01010399 ↗ |
| Known as | Fosamprenavir calcium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1664 ↗ |
| Known as | FOSAMPRENAVIR SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1664 ↗ |
| Known as | Fosamprenavir(Lexiva) | “Fosamprenavir(Lexiva)” NCT00727597 ↗ |
| Known as | fosamprenavir/r | “Background regimen may consist of the following ritonavir (RTV)-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r.” NCT01923311 ↗ |
| Known as | FPV | “Fosamprenavir (FPV, TELZIR) is currently licensed in Europe for twice daily (BID) dosing in combination with ritonavir (RTV, Norvir) as a boosting agent” NCT00450580 ↗8“Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)” NCT00040664 ↗ “allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)” NCT01475838 ↗ “this study compared fosamprenavir (FPV) boosted with RTV 100 mg (FPV/r100) or with RTV 200 mg (FPV/r200) daily.” PMID 21126954 ↗ Sep 2010 “GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir” NCT00296504 ↗ “fosamprenavir (FPV; Lexiva®) + RTV” NCT02605954 ↗ “fosamprenavir (FPV; Lexiva®) + RTV” NCT02616783 ↗ “2) fosamprenavir (FPV) and RTV;” NCT00027339 ↗ “Fosamprenavir (FPV)” NCT00764465 ↗ |
| Known as | GW 433908A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1664 ↗ |
| Known as | GW 433908G | ChEMBL registry synonym — accepted as the source's own label CHEMBL1664 ↗ |
| Known as | GW433908 | “fosamprenavir (GW433908)” NCT00296504 ↗ |
| Known as | Lexiva | “Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day” NCT01010399 ↗4“fosamprenavir (FPV; Lexiva®) + RTV” NCT02605954 ↗ “fosamprenavir (FPV; Lexiva®) + RTV” NCT02616783 ↗ “Lexiva (fosamprenavir)” NCT00148785 ↗ “fosamprenavir (Lexiva)” NCT00877591 ↗ |
| Known as | TELZIR | “Fosamprenavir (FPV, TELZIR) is currently licensed in Europe for twice daily (BID) dosing in combination with ritonavir (RTV, Norvir) as a boosting agent” NCT00450580 ↗ |
| Action | Inhibit | “Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors” NCT00242216 ↗ |
| Modality | Small molecule | — CHEMBL1664 ↗ |
| Route | Oral | “fosamprenavir oral suspension or tablet” NCT00040664 ↗ |