ACYCLOVIR SODIUM

Post-LOESM

acyclovir

Hikma

ANDAINJECTIONINJECTABLE1 Generic Approved

Approved

Feb 2016

Lifecycle

Post-LOE

Competitive Pressure

45/100

Clinical Trials

Data completeness

2/8 — Basic

Drug data last refreshed 12h ago

Mechanism of Action

Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (20)

NCT06228430Phase 1Unknown

The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions

Started Feb 2024

40 enrolled

Healthy Volunteer

NCT05468619Phase 1Completed

Neonatal Phase 1 Valacyclovir Study

Started Aug 2023

17 enrolled

Herpes Simplex

NCT05098938Phase 3Completed

A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally

Started Nov 2021

2,020 enrolled

Recurrent Herpes Labialis

NCT04988646N/ACompleted

Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject

Started Feb 2020

56 enrolled

Drug Use

NCT04664127N/ACompleted

Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel

Started Oct 2017

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.