Drugs / Valaciclovir
Valaciclovir
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02226978 | Feb → May 2007 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00297206 | Jan 2003 → Feb 2007 | herpes simplex infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT03699904 | Oct 2018 → May 2020 | Epstein-Barr virus infection, chronic obstructive pulmonary disease | Belfast Health and Social Care Trust | Terminated | Met primary Stop: Enrollment |
| Phase 2 | NCT02997982 | Dec 2016 → Mar 2020 | Alzheimer disease, herpes simplex infectious disease, subjective cognitive decline | Hugo Lovheim | Completed | No outcome recorded |
| Phase 2 | NCT01503918 | Jan 2012 → Jan 2014 | — | University Hospital Birmingham NHS Foundation Trust | Completed | Met primary |
| Phase 2 | NCT01364792 | Apr 2011 → Aug 2015 | schizophrenia | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT00652184 | Mar 2008 → Jun 2009 | herpes zoster, postherpetic neuralgia | aRigen Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT05902208 | Feb 2024 → May 2026 | chronic periodontitis | Centre Hospitalier Universitaire de Nice | Unknown | No outcome recorded |
| Phase 3 | NCT01959841 | Aug 2013 → Jul 2015 | herpes zoster | Maruho Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT01602562 | May 2012 → May 2013 | herpes simplex infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00169416 | Mar → Aug 2005 | chickenpox | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00001649 | Aug 1997 → Aug 2003 | genital herpes | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 44 trials · 2 met primary | ||||||
| Phase 4 | NCT00343278 | Jul → Aug 2005 | viral infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00116844 | Mar 2005 → Jan 2006 | Herpesviridae infectious disease | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00158860 | Jun 2004 → Jul 2006 | genital herpes simplex type 2 infectious disorder | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00510263 | May 2001 → Sep 2007 | Bell's palsy | Uppsala University Hospital | Completed | Mixed |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT07346144 Background | Apr 2026 → Mar 2030 expected | glioblastoma | Trogenix ltd | Recruiting | No outcome recorded |
| Phase 2 | NCT04165122 Comparator | Nov 2019 → Aug 2021 | genital herpes | Heidelberg ImmunoTherapeutics GmbH | Completed | Missed primary |
| Phase 2 | NCT01633476 Comparator | Jul 2013 → Feb 2016 | anti-neutrophil cytoplasmic antibody-associated vasculitis, cytomegalovirus infection | Professor Lorraine Harper | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-12-26 | Hyloris Developments | Results Hyloris Announces Positive Clinical Study Results for Valacyclovir Oral Suspension (HY-029) hyloris.com ↗
Clinical Study Demonstrates Comparable Relative Bioavailability to Valaciclovir Tablets under fasted conditions |
| 2010-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Launch of Generic Valtrex® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of its generic version of GlaxoSmithKline's antiviral product, Valtrex® (valacyclovir hydrochloride) Tablets 500 mg and 1 g. |
| 2007-10-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Generic Valtrex® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA announced today that the U.S. Food and Drug Administration(FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline's antiviral product Valtrex® (Valacyclovir Hydrochloride) Tablets. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-12-26 | Hyloris Developments | Hyloris Announces Positive Clinical Study Results for Valacyclovir Oral Suspension (HY-029) hyloris.com ↗ |
| 2010-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of Generic Valtrex® tevapharm.com ↗ |
| 2007-10-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Generic Valtrex® tevapharm.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Valaciclovir | “Valaciclovir, a antiviral treatment will be added to the conventional non-surgical treatment of generalized periodontitis. One gram per day will be administered” NCT05902208 ↗ |
| Known as | VACV | “To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.” NCT01959841 ↗2“Valaciclovir (VACV), the L-valyl ester prodrug of aciclovir (ACV), is extensively converted to ACV and L-valine after oral administration.” NCT00343278 ↗ “256U87 (VACV: valaciclovir)” NCT01602562 ↗ |
| Known as | VAL | “Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a prodrug of aciclovir (ACV)” NCT02226978 ↗ |
| Known as | valacyclovir hydrochloride | “with valacyclovir hydrochloride (n = 34) or low-dose valganciclovir hydrochloride” PMID 28437539 ↗ Jun 2017 |
| Known as | Valtrex | “Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF” NCT00297206 ↗ |
| Action | Inhibit | “Valaciclovir prevents the herpes virus from multiplying” NCT00001649 ↗ |
| Route | Oral | “The source partner will be randomly assigned to take either a 500-mg tablet of valaciclovir or placebo (a pill with no active ingredient) daily for 8 months.” NCT00001649 ↗ |