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Drug

Acyclovir

Approved · FDA
Emerging researchLate-stage development
Also known as 9-((2-hydroxyethoxy)methyl)guanine, Aciclovir, Aciclovirum, Acycloguanosine+6 more

9-((2-hydroxyethoxy)methyl)guanine, Aciclovir, Aciclovirum, Acycloguanosine, Acyclovir Topical, Avaclyr, Sitavig, Xerese, Zovirax, Acyclovir Sodium.

RxNorm281ChEMBLCHEMBL184UNIIX4HES1O11F
1
Research papers
5
Active clinical trials
33
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: ACYCLOVIR (ANDA212252)

Regulatory2026-07-02FDA

Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Label change: ACYCLOVIR (ANDA074738)

Regulatory2026-07-01FDA

Label change: ACYCLOVIR (ANDA212718)

Regulatory2026-07-01FDA

Label change: ACYCLOVIR (ANDA213951)

Regulatory2026-07-01FDA

Label change: ACYCLOVIR (ANDA215669)

Regulatory2026-07-01FDA

Label change: ACYCLOVIR (ANDA216331)

Regulatory2026-07-01FDA

A Phase 1b, Multicenter, Dose Escalation, Evaluation of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Label change: ACYCLOVIR (ANDA210401)

Regulatory2026-06-24FDA

Prevention of Recurrence of Herpes Simplex in Patients With Autoimmune Rheumatic Diseases

Clinical trial2026-03-05Results expected Q2 2027 · ClinicalTrials.gov

Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir

Clinical trial2025-12-31Results expected Q4 2026 · ClinicalTrials.gov

Oral acyclovir suppression and neurodevelopment after neonatal herpes.

Research2011-10-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Acyclovir
Aliases & brands
9-((2-hydroxyethoxy)methyl)guanineAciclovirAciclovirumAcycloguanosineAcyclovir TopicalAvaclyrSitavigXereseZoviraxAcyclovir Sodium
RxNorm CUI
281
ChEMBL ID
CHEMBL184
UNII
X4HES1O11F
Regulatory jurisdictions
fda

Regulatory timeline

33 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1997-04-28
Latest approval
2022-07-01
Authorities
FDA
Total events
33
fdaU.S. Food and Drug Administration· 33 events
2026-07-02Label change
Label change: ACYCLOVIR (ANDA212252)
Evidence ↗
2026-07-01Label change
Label change: ACYCLOVIR (ANDA216331)
Evidence ↗
2026-07-01Label change
Label change: ACYCLOVIR (ANDA212718)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

73 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
73
registered trials across all phases
LATEST COMPLETION 2024
5
Active studies
5
Recruiting
53
Late-stage (III+)
57
Completed
11
Discontinued
PHASE DISTRIBUTIONn = 73
Phase 18Phase 1 / 24Phase 28Phase 2 / 34Phase 321Phase 412Phase N / A16

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Prevention of Recurrence of Herpes Simplex in Patients With Autoimmune Rheumatic Diseases

Not yet recruitingPH IVUniversity of Sao Paulo General Hospitaln=622028

Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial

CompletedPH IVAssistance Publique Hopitaux De Marseillen=3172023

Effects of Melatonin in the Treatment of Genital Herpes

CompletedPH IVUniversity of Sao Paulo General Hospitaln=902021

A Multi-centered, Randomized Study to Evaluate the Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection Compared to Intravenous Acyclovir in Patients With Herpes Zoster From China

CompletedPH IVCttqn=942019

Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA

CompletedPH IVGenzyme, a Sanofi Companyn=582016

Recent completions

Trials that read out recently, adding to the completed evidence base.

Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis

CompletedN/AAl-Azhar Universityn=202024

A Phase I/II Study of Carfilzomib in Combination With R-CHOP (CR-CHOP) for Patients With Diffuse Large B-cell Lymphoma

CompletedPH I/IICase Comprehensive Cancer Centern=482023

Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial

CompletedPH IVAssistance Publique Hopitaux De Marseillen=3172023

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

CompletedPH IIIMerck Sharp & Dohme LLCn=6012022

Effects of Melatonin in the Treatment of Genital Herpes

CompletedPH IVUniversity of Sao Paulo General Hospitaln=902021

A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis

CompletedPH IGenzyme, a Sanofi Companyn=242021

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Oral acyclovir suppression and neurodevelopment after neonatal herpes.

The New England journal of medicine · 2011 · 163 cites
Recent papers

Oral acyclovir suppression and neurodevelopment after neonatal herpes.

The New England journal of medicine · 2011 · 163 cites
Journals, researchers & institutions
Top journals
  • The New England journal of medicine1
Leading researchers
  • Abughali N1
  • Ahmed A1
  • Bradley JS1
  • Brady RC1
  • Cloud GA1
  • Dennehy PH1
  • Frenkel LM1
  • Griffin J1
Leading institutions
free-text, unnormalised
  • University of Alabama at Birmingham1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.