Valacyclovir
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | VALTREX | — | 1996-10-04 – 2008-09-02 | fda.gov ↗ |
| Approved | US (FDA) | VALTREX | — | 1995-06-23 | fda.gov ↗ |
Trials 71 · started per year
Also used as a comparator or background therapy in 42 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT06914479 Background | May 2026 → May 2031 expected | brain cancer, diffuse glioma, H3 G34 mutant | University of Michigan Rogel Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT03131037 Background | May 2017 → Dec 2021 | lung cancer | Candel Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02571166 Background | Nov 2015 → Dec 2018 | herpes simplex type 2 infectious disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01811992 Background | Apr 2014 → Feb 2019 | glioblastoma | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01997190 Background | Oct 2013 → Dec 2015 | breast cancer, lung cancer, mesothelioma, ovarian cancer +1 | Candel Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00634231 Background | Oct 2010 → Dec 2015 | ependymoma, malignant glioma | Candel Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00870441 Comparator | Mar 2009 → Apr 2010 | — | Astellas Pharma Inc | Terminated | No outcome recorded |
| Phase 1 | NCT00751270 Background | Nov 2005 → Jan 2010 | anaplastic astrocytoma, glioblastoma | Candel Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01149499 Comparator | Jan 2005 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT01149460 Comparator | Sep 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01913106 Background | Jun 2007 → Dec 2018 overdue | prostate cancer | The Methodist Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT05536349 Background | Dec 2022 → Apr 2028 expected | leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05492591 Comparator | Oct 2022 → Jul 2023 | herpes zoster | Shanghai Institute Of Biological Products | Completed | No outcome recorded |
| Phase 2 | NCT04710030 Comparator | Feb 2021 → Oct 2024 | cognitive impairment with or without cerebellar ataxia, herpes simplex type 1 infectious disease, herpes simplex type 2 infectious disease | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT03282916 Comparator | Feb 2018 → Sep 2024 | Alzheimer disease, herpes simplex type 1 infectious disease, herpes simplex type 2 infectious disease | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT02768363 Comparator | May 2016 → Nov 2024 overdue | prostate cancer | Candel Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02008773 Comparator | Mar 2014 → Jun 2017 | schizophrenia | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT00900783 Comparator | May 2009 → Nov 2010 | herpes zoster | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00487682 Comparator | Nov 2007 → Sep 2008 | herpes zoster | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00831103 Comparator | Nov 2007 → Jun 2009 | herpes zoster | Epiphany Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT00486200 Comparator | Jun 2007 → Aug 2008 | genital herpes | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00492050 Background | Aug 2006 → Feb 2021 overdue | Waldenstrom macroglobulinemia | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00562770 Comparator | Sep 2003 → Jul 2006 | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02351102 Comparator | Nov 2015 → Jul 2019 | cytomegalovirus infection | Rabin Medical Center | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT05446571 Comparator | Oct 2023 → Aug 2029 expected | fetal cytomegalovirus syndrome | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT07349680 Background | Mar 2023 → Sep 2025 | postherpetic neuralgia | Assiut University | Completed | No outcome recorded |
| Phase 3 | NCT02412917 Comparator | Jun 2015 → Nov 2017 | herpes zoster, postherpetic neuralgia | ContraVir Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01436968 Comparator | Sep 2011 → Aug 2024 overdue | prostate cancer | Candel Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT05452928 Comparator | Jun 2026 → Jun 2028 expected | herpes simplex type 2 infectious disease, viral meningitis | Jacob Bodilsen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03626376 Comparator | Dec 2019 → Mar 2021 | herpes simplex virus keratitis | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 4 | NCT03134196 Comparator | Aug 2017 → Dec 2023 | ophthalmic herpes zoster | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT01026454 Comparator | Feb → Nov 2010 | HIV infectious disease, herpes simplex type 2 infectious disease | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT00362297 Comparator | Sep 2006 → Dec 2008 | genital herpes | University of Washington | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT07515885 Background | Sep 2025 → Dec 2028 expected | herpes zoster | Dexiong Han | Recruiting | No outcome recorded |
| — | NCT06643247 Background | Nov 2024 → Dec 2027 expected | herpes zoster | First People's Hospital of Hangzhou | Recruiting | No outcome recorded |
| — | NCT03514771 Background | Jan 2016 → Mar 2017 | mixed dermis disorder | David Smart | Completed | No outcome recorded |
| — | NCT00682721 Comparator | Feb 2009 → Sep 2010 | bacterial vaginosis, herpes simplex type 2 infectious disease | University of Pittsburgh | Withdrawn | No outcome recorded |
| — | NCT00803543 Comparator | Jan 2009 → Apr 2014 | HIV infectious disease | University of Alabama at Birmingham | Completed | No outcome recorded |
| — | NCT00561106 Comparator | Dec 2002 → Dec 2003 | Bell's palsy | University of the Republic | Completed | No outcome recorded |
| — | NCT01250561 Background | Feb 2002 → Oct 2007 | herpes zoster, postherpetic neuralgia | Center for Clinical Studies, Texas | Completed | No outcome recorded |
| — | NCT01686464 Comparator | Jun 1998 → Jan 2005 | Bell's palsy | Wenzhou Medical University | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 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 14 cited values
Every value below carries the sentence it was read from. 114 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Valacyclovir | “Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954 ↗109“Valacyclovir treatment will begin 1-3 days after vector administration at a dose of 2 grams given orally 3X per day for 14 days.” NCT01811992 ↗ “Patients are randomised to active treatment with IV acyclovir with the possibility of step-down to valacyclovir.” NCT05452928 ↗ “Valacyclovir Hydrochloride Tablets” NCT06474416 ↗ |
| Known as | 256U87 | “To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride ( 256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold...” NCT00001054 ↗2“oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients” NCT00002000 ↗ “oral valacyclovir hydrochloride ( 256U87 )” NCT00002084 ↗ |
| Known as | BW 256U87 | “PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with...” NCT00001038 ↗ |
| Known as | VACV | “using maternal oral administration of valaciclovir (VACV).” PMID 17617198 ↗ Jul 2007 |
| Known as | Valacyclovir HCI | “Valacyclovir HCI 500 mg capsules 6/day oral for 16 weeks” NCT02008773 ↗ |
| Known as | valacyclovir HCl | “VALTREX® (valacyclovir HCl) caplets 1 gm of GlaxoSmithKline Research Triangle Park, NC 27709” NCT01222897 ↗1“VALTREX® (valacyclovir HCl) caplets 1 gm of GlaxoSmithKline Research Triangle Park, NC 27709” NCT01222910 ↗ |
| Known as | Valacyclovir hydrochloride | “The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GSK's Valtrex® 1000 mg tablets following a single,...” NCT00650494 ↗11“PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with...” NCT00001038 ↗ “Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting...” NCT00649974 ↗ “oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients” NCT00002000 ↗ “Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.” NCT00001054 ↗ “All participants will receive Valacyclovir Hydrochloride tablets and Mecobalamin tablets.” NCT06643247 ↗ “Valacyclovir hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901” NCT01222897 ↗ “Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited” NCT01136538 ↗ “Valacyclovir Hydrochloride Tablets 1000 mg” NCT00649870 ↗ “Valacyclovir hydrochloride 500mg caplet” NCT04710030 ↗ |
| Known as | Valacyclovir Hydrochloride Tablets | “Valacyclovir Hydrochloride Tablets” NCT06474416 ↗ |
| Known as | Valtrex | “The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GSK's Valtrex® 1000 mg tablets following a single,...” NCT00650494 ↗8“Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting...” NCT00649974 ↗ “You will also be given 4 pills called (Valtrex) valacyclovir to take three times a day for 14 days, beginning the day before the procedure.” NCT01913106 ↗ “The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections” NCT00005663 ↗ “an antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis” NCT00175513 ↗ “amoxicillin 500mg + Valtrex (valacyclovir 500mg x three times daily for 7 days)” NCT05266040 ↗ “The Efficacy of Systemic Valacyclovir (Valtrex) on Periodontitis” NCT05712343 ↗ “VALTREX(Valacyclovir) Once Daily” NCT00306293 ↗ “Valacyclovir (Valtrex)” NCT07294547 ↗ |
| Known as | Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm | “Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm” NCT01136525 ↗1“Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm” NCT01136538 ↗ |
| Known as | VAV | “The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional antipsychotic drug treatment will be evaluated.” NCT01794897 ↗1“add-on treatment of Valacyclovir (VAV), an antiviral medication” NCT00514449 ↗ |
| Known as | ZELITREX | “Valacyclovir (ZELITREX)” NCT01037712 ↗ |
| Action | Inhibit | “valacyclovir) will reduce the amount of Epstein-Barr virus (EBV) in the mouths of university students with infectious mononucleosis” NCT00274404 ↗ |
| Route | Oral | “oral valacyclovir hydrochloride” NCT00001054 ↗ |