Valacyclovir

also known as Valacyclovir Hydrochloride · Valtrex · 256U87 · valacyclovir HCl · Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm · VAV · BW 256U87 · VACV · +3 more

Developed for: HIV infectious disease · herpes simplex infectious disease · cytomegalovirus infection · genital herpes · chronic hepatitis C virus infection · herpes simplex type 2 infectious disease · Epstein-Barr virus infection · genital herpes simplex type 2 infectious disorder
+42 more
· herpes labialis · herpes zoster · long COVID-19 · non-small cell lung carcinoma · schizoaffective disorder · schizophrenia · varicella zoster infection · achalasia · acute apical periodontitis · anaplastic astrocytoma · bipolar disorder · chickenpox · chronic pain syndrome · dental abscess · disease related to solid organ transplantation · encephalitis · glioblastoma · herpes simplex virus gingivostomatitis · herpes simplex virus keratitis · Herpesviridae infectious disease · immunodeficiency disease · infectious embryofetopathy · infectious mononucleosis · malignant glioma · mucositis · non-small cell squamous lung carcinoma · overactive bladder · pancreatic adenocarcinoma · periapical periodontitis · periodontitis · prostate adenocarcinoma · prostate cancer · psychotic disorder · triple-negative breast carcinoma · uveal melanoma · Alzheimer disease · Bell's palsy · cognitive impairment with or without cerebellar ataxia · fetal cytomegalovirus syndrome · ophthalmic herpes zoster · postherpetic neuralgia · viral meningitis
Investigated by: GlaxoSmithKline · University of Washington · Glaxo Wellcome · Candel Therapeutics, Inc. · National Institute of Allergy and Infectious Diseases (NIAID) · Stanley Medical Research Institute
+61 more
· Mylan Pharmaceuticals Inc · Asociación Civil Impacta Salud y Educación, Peru · Assistance Publique - Hôpitaux de Paris · Baylor College of Medicine · Dr. Reddy's Laboratories Limited · National Cancer Institute (NCI) · Radboud University Medical Center · Ranbaxy Laboratories Limited · The Methodist Hospital Research Institute · University Health Network, Toronto · University of California, San Francisco · University of Minnesota · University of Toronto · VA Office of Research and Development · AiCuris Anti-infective Cures AG · Bateman Horne Center · Bristol-Myers Squibb · Buddhist Tzu Chi General Hospital · CIHR Canadian HIV Trials Network · Canadian Association of Emergency Physicians · Canadian Institutes of Health Research (CIHR) · Columbia University · Dow University of Health Sciences · Dr. Ram Manohar Lohia Hospital · Eric Bernicker, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Fred Hutchinson Cancer Center · French National Agency for Research on AIDS and Viral Hepatitis · G.V. (Sonny) Montgomery VA Medical Center · Hoffmann-La Roche · Hospital Sirio-Libanes · Hualien Tzu Chi General Hospital · Icahn School of Medicine at Mount Sinai · Instituto Oncoclinicas · Johns Hopkins University · Konasale Prasad · Medpace, Inc. · Merck Sharp & Dohme LLC · Ministry of Science and Technology, Taiwan · Minnesota Medical Foundation · National Center for Research Resources (NCRR) · National Eye Institute (NEI) · National Institutes of Health (NIH) · National Taiwan University Hospital · Novartis Pharmaceuticals · Oswaldo Cruz Foundation · Puget Sound Partners for Global Health · Royalty Research Fund - University of Washington · Shanghai BDgene Co., Ltd. · St. Justine's Hospital · Tehran University of Medical Sciences · URC-CIC Paris Descartes Necker Cochin · University of Alabama at Birmingham · University of British Columbia · University of Maryland, Baltimore · University of Pittsburgh · University of Texas · University of Utah · Vanderbilt University Medical Center · Wayne State University · ZonMw: The Netherlands Organisation for Health Research and Development

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed	US (FDA)	—	herpes virus infections	2025-02-25	“today announces the U.S. FDA has accepted for review the New Drug Application (NDA) for its proprietary Valacyclovir oral suspension.” hyloris.com ↗
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

today

US approved 1995

1995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT05712343	May 2023 → Mar 2024	periodontitis	University of California, San Francisco	Unknown	No outcome recorded
Phase 116 trials
Phase 1	NCT06474416	Sep 2023 → Oct 2025 overdue	herpes simplex virus keratitis	Shanghai BDgene Co., Ltd.	Active not recruiting	No outcome recorded
Phase 1	NCT05468619	Aug 2023 → Jun 2025	herpes simplex infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT04448392	Jul 2021 → Jul 2024	Herpesviridae infectious disease	University of Alabama at Birmingham	Completed	No outcome recorded
Phase 1	NCT05094414	Jul 2021 → Feb 2022	chronic pain syndrome, overactive bladder	Buddhist Tzu Chi General Hospital	Unknown	No outcome recorded
Phase 1	NCT03576612	Feb 2018 → Jun 2023	malignant glioma	Candel Therapeutics, Inc.	Completed	No outcome recorded
Phase 1	NCT01453075	Nov 2011 → Jul 2015	chronic hepatitis C virus infection	VA Office of Research and Development	Completed	No outcome recorded
Phase 1	NCT01037621	Apr 2010 → Feb 2012	chronic hepatitis C virus infection, herpes simplex type 2 infectious disease	G.V. (Sonny) Montgomery VA Medical Center	Unknown	No outcome recorded
Phase 1	NCT00638612	Aug 2008 → May 2013	pancreatic adenocarcinoma	Candel Therapeutics, Inc.	Completed	No outcome recorded
Phase 1	NCT01136525	Feb → Mar 2007	—	Dr. Reddy's Laboratories Limited	Completed	No outcome recorded
Phase 1	NCT01136538	Feb 2007	—	Dr. Reddy's Laboratories Limited	Completed	No outcome recorded
Phase 1	NCT00587496	Apr 2006 → Jul 2008	herpes simplex infectious disease	National Eye Institute (NEI)	Unknown	No outcome recorded
Phase 1	NCT00650494	Aug 2005	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00649870	May 2005	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00649974	May 2005	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00059592	Apr 1998 → Dec 2004	herpes zoster	Baylor College of Medicine	Completed	No outcome recorded
Phase 1	NCT00001054	? → Jan 2001	HIV infectious disease, chickenpox, herpes simplex infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded

Phase 1/21 trial
Phase 1/2	NCT00274404	Feb 2004 → Sep 2005	infectious mononucleosis	University of Minnesota	Completed	No outcome recorded
Phase 220 trials · 1 met primary · 1 missed
Phase 2	NCT07597902	Jun 2026 → Jun 2028 expected	long COVID-19	Icahn School of Medicine at Mount Sinai	Not yet recruiting	No outcome recorded
Phase 2	NCT07332000	Oct 2025 → Feb 2027 expected	prostate adenocarcinoma	Candel Therapeutics, Inc.	Recruiting	No outcome recorded
Phase 2	NCT05266040	Oct 2023 → Dec 2025 overdue	acute apical periodontitis	University of California, San Francisco	Recruiting	No outcome recorded
Phase 2	NCT06316843	Oct 2023 → Oct 2024	long COVID-19	Bateman Horne Center	Completed	No outcome recorded
Phase 2	NCT07363031	Sep 2022 → Jun 2026 overdue	head and neck cancer, mucositis	Instituto Oncoclinicas	Enrolling by invitation	No outcome recorded
Phase 2	NCT03541928	Aug 2018 → Jul 2023	prostate cancer	The Methodist Hospital Research Institute	Unknown	No outcome recorded
Phase 2	NCT03004183	Jul 2017 → Jul 2022	non-small cell lung carcinoma, triple-negative breast carcinoma	The Methodist Hospital Research Institute	Completed	No outcome recorded
Phase 2	NCT02831933	Feb 2017 → Nov 2020	non-small cell squamous lung carcinoma, uveal melanoma	Eric Bernicker, MD	Terminated	No outcome recorded Stop: Business
Phase 2	NCT02738229	Jul 2016 → Dec 2022	herpes simplex virus gingivostomatitis	St. Justine's Hospital	Completed	No outcome recorded
Phase 2	NCT01972035	Aug 2014 → Feb 2021	Epstein-Barr virus infection, cytomegalovirus infection, disease related to solid organ transplantation	University of Minnesota	Completed	No outcome recorded
Phase 2	NCT01658826	Oct 2012 → May 2013	genital herpes	AiCuris Anti-infective Cures AG	Terminated	Met primary
Phase 2	NCT01580995	Apr 2012 → Dec 2014	chronic hepatitis C virus infection	VA Office of Research and Development	Completed	Missed primary
Phase 2	NCT00530777	Apr 2008 → Aug 2010	HIV infectious disease, herpes simplex infectious disease	University of Washington	Completed	No outcome recorded
Phase 2	NCT00514449	Jun 2007 → Sep 2016	schizoaffective disorder, schizophrenia	Konasale Prasad	Completed	No outcome recorded
Phase 2	NCT00589875	Mar 2007 → Dec 2015	anaplastic astrocytoma, glioblastoma	Candel Therapeutics, Inc.	Completed	No outcome recorded
Phase 2	NCT00428298	Mar 2007 → Aug 2012	bipolar disorder	Johns Hopkins University	Completed	No outcome recorded
Phase 2	NCT00175513	Sep 2005 → Sep 2009	psychotic disorder	University of British Columbia	Completed	No outcome recorded
Phase 2	NCT00297011	Sep 2004 → Mar 2007	herpes labialis	University of Utah	Completed	No outcome recorded
Phase 2	NCT00158509	Aug 2004 → Jul 2005	HIV infectious disease, genital herpes simplex type 2 infectious disorder	French National Agency for Research on AIDS and Viral Hepatitis	Completed	No outcome recorded
Phase 2	NCT00042328	Aug 2001 → May 2005	neoplasm	Baylor College of Medicine	Completed	No outcome recorded

Phase 310 trials · 2 missed
Phase 3	NCT07660094	Jun 2026 → Oct 2031 expected	non-small cell lung carcinoma	Candel Therapeutics, Inc.	Recruiting	No outcome recorded
Phase 3	NCT01176409	Sep 2010 → Aug 2013	HIV infectious disease, herpes simplex infectious disease	University Health Network, Toronto	Completed	Missed primary
Phase 3	NCT00860977	Mar 2010 → Aug 2015	HIV infectious disease, herpes simplex type 2 infectious disease	University Health Network, Toronto	Completed	No outcome recorded
Phase 3	NCT00306787	Mar 2006 → Feb 2008	genital herpes	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00465205	Jan → Dec 2005	HIV infectious disease, herpes simplex infectious disease	University of Washington	Completed	No outcome recorded
Phase 3	NCT00378976	Aug 2003 → Jul 2004	HIV infectious disease, herpes simplex infectious disease	University of Washington	Completed	No outcome recorded
Phase 3	NCT00045292	Apr 2002 → Oct 2004	cancer	Fred Hutchinson Cancer Center	Completed	No outcome recorded
Phase 3	NCT00031486	Sep 2000 → Jun 2010	encephalitis	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 3	NCT00005663	Jun 1999 → ?	HIV infectious disease, genital herpes	Glaxo Wellcome	Unknown	No outcome recorded
Phase 3	NCT00001038	? → May 1996	HIV infectious disease, cytomegalovirus infection	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 412 trials · 3 met primary
Phase 4	NCT06344195	Mar → Apr 2024	dental abscess	Dow University of Health Sciences	Unknown	No outcome recorded
Phase 4	NCT05550194	Mar 2023 → Aug 2027 expected	achalasia	Vanderbilt University Medical Center	Recruiting	No outcome recorded
Phase 4	NCT04640571	Apr → Nov 2021	—	University of Maryland, Baltimore	Completed	No outcome recorded
Phase 4	NCT01794897	Feb 2013 → Sep 2016	herpes simplex infectious disease, schizoaffective disorder, schizophrenia	University of Pittsburgh	Completed	No outcome recorded
Phase 4	NCT01682109	Sep 2012 → Mar 2016	herpes simplex infectious disease, varicella zoster infection	Radboud University Medical Center	Completed	Met primary
Phase 4	NCT01651585	Jul 2011 → May 2015	cytomegalovirus infection, infectious embryofetopathy	Assistance Publique - Hôpitaux de Paris	Completed	Met primary
Phase 4	NCT01037712	Sep 2009 → Mar 2011	cytomegalovirus infection	Assistance Publique - Hôpitaux de Paris	Terminated	No outcome recorded
Phase 4	NCT01346475	Nov 2008 → Jul 2010	genital herpes	University of Washington	Completed	Met primary
Phase 4	NCT00527618	Dec 2007 → Mar 2011	HIV infectious disease, genital herpes simplex type 2 infectious disorder	University of Washington	Completed	Mixed
Phase 4	NCT00306293	Feb → Nov 2006	herpes labialis	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00079911	Mar → Oct 2004	genital herpes	GlaxoSmithKline	Terminated	No outcome recorded
Phase 4	NCT00161434	Mar 2003 → Jun 2006	HIV infectious disease, herpes simplex infectious disease	University of Washington	Completed	No outcome recorded

Phase not applicable11 trials · 1 missed
—	NCT07294547	Nov 2025 → Dec 2029 expected	Epstein-Barr virus infection, cytomegalovirus infection	National Taiwan University Hospital	Recruiting	No outcome recorded
—	NCT07014397	Nov 2024 → Mar 2025	periapical periodontitis	Tehran University of Medical Sciences	Completed	No outcome recorded
—	NCT04081480	Dec 2019 → May 2021	herpes simplex infectious disease, varicella zoster infection	Radboud University Medical Center	Terminated	No outcome recorded
—	NCT00946556	Apr 2010 → May 2011	HIV infectious disease, herpes simplex type 2 infectious disease	University of Toronto	Completed	Missed primary
—	NCT01059084	Jan 2010 → Dec 2012	HIV infectious disease	University of Washington	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT01222910	May 2009	—	Ranbaxy Laboratories Limited	Completed	No outcome recorded
—	NCT01222897	May 2009	—	Ranbaxy Laboratories Limited	Completed	No outcome recorded
—	NCT00006131	Jan 1997 → ?	herpes zoster, immunodeficiency disease	National Center for Research Resources (NCRR)	Completed	No outcome recorded
—	NCT00002404	—	HIV infectious disease, herpes simplex infectious disease	Glaxo Wellcome	Completed	No outcome recorded
—	NCT00002000	—	HIV infectious disease, herpes simplex infectious disease	Glaxo Wellcome	Completed	No outcome recorded
—	NCT00002084	—	HIV infectious disease, herpes simplex infectious disease	Glaxo Wellcome	Completed	No outcome recorded

Comparator or background therapy42 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 1/2	NCT01913106 Background	Jun 2007 → Dec 2018 overdue	prostate cancer	The Methodist Hospital Research Institute	Recruiting	No outcome recorded
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 2/3	NCT02351102 Comparator	Nov 2015 → Jul 2019	cytomegalovirus infection	Rabin Medical Center	Completed	No outcome recorded
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	Met primary
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 Stop: Enrollment
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	Missed primary
—	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

News releases announcing trial results or a regulatory action · 6

Date	Issuer	Release
2025-02-25	Hyloris Developments	Regulatory Hyloris Announces FDA Acceptance of New Drug Application (NDA) for Valacyclovir Oral Liquid hyloris.com ↗ Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) , a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces the U.S. FDA has accepted for review the New Drug Application (NDA) for its proprietary Valacyclovir oral suspension.
2024-12-29	Hyloris Developments	Results Hyloris Announces Positive Study Results for Valacyclovir Oral Suspension for European Markets hyloris.com ↗ The study confirms that the product demonstrates comparable relative bioavailability to Valtrex® tablets, as marketed in Europe, under fasted conditions.
2024-08-12	Hyloris Developments	Results Positive Study Results and Strengthens Global Reach for Valacyclovir Oral Suspension with Expanded Rights hyloris.com ↗ The additional pivotal clinical study demonstrates comparable relative bioavailability to Valtrex® tablets , as sold in the U.S, under fasted conditions.
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 7 releases

Date	Issuer	Release
2025-02-25	Hyloris Developments	Hyloris Announces FDA Acceptance of New Drug Application (NDA) for Valacyclovir Oral Liquid hyloris.com ↗
2024-12-29	Hyloris Developments	Hyloris Announces Positive Study Results for Valacyclovir Oral Suspension for European Markets hyloris.com ↗
2024-12-09	Hyloris Developments	Hyloris Announces Partnership with Rosemont Pharmaceuticals for Valacyclovir Oral Suspension in the U.S. hyloris.com ↗
2024-08-12	Hyloris Developments	Positive Study Results and Strengthens Global Reach for Valacyclovir Oral Suspension with Expanded Rights hyloris.com ↗
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 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 ↗ NCT00831103 ↗ NCT00042328 ↗ NCT02412917 ↗ NCT01658826 ↗ NCT00492050 ↗ NCT01149499 ↗ NCT01453075 ↗ Show 99 more sources
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 ↗ NCT01222910 ↗ Show 1 more source
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” NCT01136538 ↗ 1 “Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm” NCT01136525 ↗
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 ↗