Last reviewed 2026-05-15 · How we verify

Acyclovir 5 percent (Perrigo)

Padagis LLC · Phase 3 active Small molecule

Acyclovir 5 percent (Perrigo) is a Nucleoside analog antiviral Small molecule drug developed by Padagis LLC. It is currently in Phase 3 development for Herpes simplex virus infection (topical), Varicella-zoster virus infection (topical). Also known as: Perrigo product.

Acyclovir is a nucleoside analog that inhibits viral DNA polymerase, preventing herpes simplex virus and varicella-zoster virus from replicating.

Acyclovir is a nucleoside analog that inhibits viral DNA polymerase, preventing herpes simplex virus and varicella-zoster virus from replicating. Used for Herpes simplex virus infection (topical), Varicella-zoster virus infection (topical).

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Acyclovir 5 percent (Perrigo)
Also known as	Perrigo product
Sponsor	Padagis LLC
Drug class	Nucleoside analog antiviral
Target	Viral DNA polymerase
Modality	Small molecule
Therapeutic area	Infectious Disease / Virology
Phase	Phase 3

Mechanism of action

Acyclovir is phosphorylated by viral thymidine kinase to its active form, which then inhibits viral DNA polymerase and causes chain termination of viral DNA synthesis. This selective mechanism targets infected cells while minimizing effects on uninfected host cells. It is effective against herpes simplex virus types 1 and 2, and varicella-zoster virus.

Approved indications

Herpes simplex virus infection (topical)
Varicella-zoster virus infection (topical)

Common side effects

Local irritation or burning at application site
Pruritus
Erythema

Key clinical trials

Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Acyclovir 5 percent (Perrigo) CI brief — competitive landscape report
Acyclovir 5 percent (Perrigo) updates RSS · CI watch RSS
Padagis LLC portfolio CI

Frequently asked questions about Acyclovir 5 percent (Perrigo)

What is Acyclovir 5 percent (Perrigo)?

Acyclovir 5 percent (Perrigo) is a Nucleoside analog antiviral drug developed by Padagis LLC, indicated for Herpes simplex virus infection (topical), Varicella-zoster virus infection (topical).

How does Acyclovir 5 percent (Perrigo) work?

Acyclovir is a nucleoside analog that inhibits viral DNA polymerase, preventing herpes simplex virus and varicella-zoster virus from replicating.

What is Acyclovir 5 percent (Perrigo) used for?

Acyclovir 5 percent (Perrigo) is indicated for Herpes simplex virus infection (topical), Varicella-zoster virus infection (topical).

Who makes Acyclovir 5 percent (Perrigo)?

Acyclovir 5 percent (Perrigo) is developed by Padagis LLC (see full Padagis LLC pipeline at /company/padagis-llc).

Is Acyclovir 5 percent (Perrigo) also known as anything else?

Acyclovir 5 percent (Perrigo) is also known as Perrigo product.

What drug class is Acyclovir 5 percent (Perrigo) in?

Acyclovir 5 percent (Perrigo) belongs to the Nucleoside analog antiviral class. See all Nucleoside analog antiviral drugs at /class/nucleoside-analog-antiviral.

What development phase is Acyclovir 5 percent (Perrigo) in?

Acyclovir 5 percent (Perrigo) is in Phase 3.

What are the side effects of Acyclovir 5 percent (Perrigo)?

Common side effects of Acyclovir 5 percent (Perrigo) include Local irritation or burning at application site, Pruritus, Erythema.

What does Acyclovir 5 percent (Perrigo) target?

Acyclovir 5 percent (Perrigo) targets Viral DNA polymerase and is a Nucleoside analog antiviral.

Drug class: All Nucleoside analog antiviral drugs
Target: All drugs targeting Viral DNA polymerase
Manufacturer: Padagis LLC — full pipeline
Therapeutic area: All drugs in Infectious Disease / Virology
Indication: Drugs for Herpes simplex virus infection (topical)
Indication: Drugs for Varicella-zoster virus infection (topical)
Also known as: Perrigo product

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing