Placebo to ACV — Competitive Intelligence Brief

Placebo to ACV (Placebo to ACV) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside analog antiviral. Area: Infectious Disease / Virology.

phase 3 Nucleoside analog antiviral Viral DNA polymerase (HSV/VZV) Infectious Disease / Virology Small molecule

Target snapshot

Placebo to ACV (Placebo to ACV) — Merck Sharp & Dohme LLC. This is a Phase 3 trial comparing placebo to acyclovir (ACV), an antiviral nucleoside analog that inhibits viral DNA polymerase to prevent herpes simplex virus replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Placebo to ACV TARGET	Placebo to ACV	Merck Sharp & Dohme LLC	phase 3	Nucleoside analog antiviral	Viral DNA polymerase (HSV/VZV)
Lonsurf	TIPIRACIL	Taiho Oncology Inc	marketed	Nucleoside Analog Antiviral [EPC]	Thymidine phosphorylase	2015-01-01
Dendrid	IDOXURIDINE	Novartis	marketed	Nucleoside Analog Antiviral	Thymidine kinase, cytosolic	1963-01-01
Ribavirin (Copegus®)	Ribavirin (Copegus®)	Vertex Pharmaceuticals Incorporated	marketed	Nucleoside analog antiviral	Viral RNA-dependent RNA polymerase; inosine monophosphate dehydrogenase (IMPDH)
valganciclovir [Valcyte]	valganciclovir [Valcyte]	Hoffmann-La Roche	marketed	Nucleoside analog antiviral	Cytomegalovirus (CMV) DNA polymerase
Peginterferon alfa-2a + ribavirin	Peginterferon alfa-2a + ribavirin	Hospital Clinico Universitario San Cecilio	marketed	Interferon alpha + nucleoside analog antiviral combination	Interferon-alpha receptor (IFNAR); HCV RNA-dependent RNA polymerase
ribavirin pre-treatment	ribavirin pre-treatment	University of Roma La Sapienza	marketed	Nucleoside analog antiviral	Viral RNA-dependent RNA polymerase; guanosine triphosphate metabolism

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2029-09-22 — Lonsurf · RE46284 · US
• 2034-06-17 — Lonsurf · 10457666 · US
• 2034-06-17 — Lonsurf · 9527833 · US
• 2034-09-05 — Lonsurf · 9943537 · US
• 2037-02-03 — Lonsurf · 10456399 · US
• 2037-02-03 — Lonsurf · 10960004 · US

Sponsor landscape (Nucleoside analog antiviral class)

1. Merck Sharp & Dohme LLC · 3 drugs in this class
2. Hoffmann-La Roche · 2 drugs in this class
3. Göteborg University · 2 drugs in this class
4. Estetra · 1 drug in this class
5. Padagis LLC · 1 drug in this class
6. MinaPharm Pharmaceuticals · 1 drug in this class
7. French National Agency for Research on AIDS and Viral Hepatitis · 1 drug in this class
8. NYU Langone Health · 1 drug in this class
9. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
10. Ain Shams University · 1 drug in this class