Herpes Labialis
📧 Sign up to get email alerts when something new happens for Herpes Labialis.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS trial_result · 2026-03-13Clinical Trial Update: Viral Infections in Healthy and Immunocompromised Hosts
An NIAID-sponsored clinical trial is examining viral infections in healthy and immunocompromised hosts. It is currently recruiting and focus…
-
FDA approval · 2025-11-12FDA Approved: VALTREX — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Valtrex (valacyclovir hydrochloride) filed by GlaxoSmithKline LLC under NDA020487. The action up…
-
CLINICAL_TRIALS trial_result · 2025-09-02Clinical Trial Update: A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally [Phase 3]
A Phase 3 trial comparing Sitavig (acyclovir) buccal tablet to placebo for recurrent herpes labialis in immunocompetent participants has com…
-
FDA approval · 2025-08-22FDA Approved: PENCICLOVIR — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved the original application for penciclovir from Amneal Pharmaceuticals NY LLC, enabling a generic topical antiviral for treating …
-
CLINICAL_TRIALS trial_result · 2025-04-01Clinical Trial Update: Post-marketing Study for the Evaluation of Profilm Cold Sores [NA]
A post-marketing study evaluating Profilm Cold Sores for herpes labialis has completed.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2024-09-27FDA Approved: PENCICLOVIR — Original Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved the original application (ANDA) for penciclovir topical cream (generic) from Padagis Israel Pharmaceuticals Ltd. for the treatm…
-
FDA approval · 2023-10-26FDA Approved: DOCOSANOL — Original Application (YYBA Corp)
The FDA approved an original application (ANDA) for docosanol from YYBA Corp, authorizing the marketing of a generic docosanol product.
-
FDA approval · 2023-05-11FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for valacyclovir hydrochloride (generic valacyclovir) from Mylan Pharmaceuticals Inc., under AND…
-
FDA approval · 2023-03-23FDA Approved: VALACYCLOVIR — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)
FDA approved a supplemental application for valacyclovir from Sun Pharmaceutical Industries, a generic antiviral indicated for herpes infect…
-
FDA approval · 2022-11-09FDA Approved: PENCICLOVIR — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved the original application for penciclovir from Teva Pharmaceuticals USA, Inc. (ANDA212710), a generic topical antiviral.
-
FDA approval · 2022-10-07FDA Approved: DOCOSANOL — Original Application (H2-Pharma, LLC)
FDA approved an Original Application for docosanol filed by H2-Pharma, LLC, granting a generic approval for topical treatment of herpes simp…
-
CLINICAL_TRIALS trial_result · 2021-11-03Clinical Trial Update: Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1) [Phase 1]
A Phase 1 trial assessing immune response and general immune health in subjects infected with HSV-1 has completed with results posted in 202…
-
CLINICAL_TRIALS trial_result · 2021-11-02Clinical Trial Update: Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis [Phase 1, Phase 2]
Phase 1/2 trial evaluating SADBE for recurrent herpes labialis (cold sore) completed with posted results.
-
CLINICAL_TRIALS trial_result · 2021-07-13Clinical Trial Update: Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes [Phase 2]
Phase 2 trial completed assessing efficacy and safety of pritelivir ointment for labial herpes (Herpes Labialis).
-
CLINICAL_TRIALS trial_result · 2021-06-25Clinical Trial Update: Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis [Phase 2, Phase 3]
A clinical trial update reports safety and pharmacokinetics data for a 1500 mg single dose of famciclovir in adolescents with recurrent herp…
-
CLINICAL_TRIALS trial_result · 2021-06-15Clinical Trial Update: A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis [Phase 2]
Phase 2 trial of repeat dosing with Squaric Acid Dibutyl Ester for herpes labialis was terminated with results posted.
-
CLINICAL_TRIALS trial_result · 2021-01-05Clinical Trial Update: Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis [Phase 3]
Phase 3 trial comparing two antiviral treatments for recurrent herpes labialis has completed with posted results.
-
CLINICAL_TRIALS trial_result · 2020-12-21Clinical Trial Update: Botulinum Toxin A for Herpes Labialis [NA]
Clinical trial update for Botulinum Toxin A in treating herpes labialis; study terminated with results posted.
-
CLINICAL_TRIALS trial_result · 2020-09-07Clinical Trial Update: An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis [Phase 2]
Phase 2 open-label study evaluating BOR15001L7 for safety and efficacy in recurrent herpes labialis (cold sores).
-
FDA label_change · 2020-09-03FDA Approved: FAMCICLOVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for famciclovir, updating the labeling for this generic antiviral.
-
FDA approval · 2020-02-28FDA Approved: VALACYCLOVIR — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)
The FDA approved a supplemental application for valacyclovir from Sun Pharmaceutical Industries, Inc., resulting in changes to the product's…
-
FDA approval · 2019-07-25FDA Approved: FAMCICLOVIR — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for famciclovir filed by Apotex Corp.
-
FDA approval · 2018-11-21FDA Approved: DENAVIR — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Denavir (penciclovir) submitted by Mylan Pharmaceuticals Inc., related to its approved topical a…
-
FDA approval · 2018-11-19FDA Approved: DOCOSANOL — Original Application (Care One (Retail Business Services, LLC.))
FDA approved an original application for docosanol by Care One, establishing a generic docosanol topical product.
-
CLINICAL_TRIALS trial_result · 2018-08-16Clinical Trial Update: Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores [Phase 2]
Phase 2 trial of Merlin (Ethanol and Glycolic Acid Mixture) for episodic treatment of recurrent herpes labialis has completed with posted re…