Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acyclovir buccal/ BAYM008894/UI1614773 · 1 trial · 1 indication
Duration of episode (DOE) is defined as the time from the initiation of treatment (study intervention) to the healing of primary lesions (loss of crust) for participants who experience a vesicular lesion. For participants whose primary lesions are not vesicular in nature, duration of episode is the time from study intervention initiation to the return to normal skin as determined by the independent blinded reader of the participant's face images using a 6-point Likert scale or to the cessation of symptoms, whichever comes last.
| Arm | Type | Description |
|---|---|---|
| Acyclovir 50mg buccal/topical tablet treatment group | EXPERIMENTAL | - |
| Matching placebo group | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773 | DRUG | Oral (upper gum area), 50mg, 1 tablet. |
| Placebo | DRUG | Oral (upper gum area), 1 table. |
Inclusion Criteria: * Males or females, 18 years of age or older inclusive; * History of recurrent HL lesions where: * Recurrence is defined as at least 4 episodes in the preceding 12 months; * At least half of the episodes should be vesicular in nature; * At least half of the episodes shoul...
Acyclovir buccal/BAYM008894/UI1614773 is being developed for the treatment of recurrent herpes labialis, commonly known as cold sores. It is an investigational small molecule antiviral therapy intended for adults with normal immune function. The drug is administered as a 50 mg buccal or topical tablet.
Acyclovir buccal/BAYM008894/UI1614773 is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating this investigational therapy for recurrent herpes labialis.
Acyclovir buccal/BAYM008894/UI1614773 is in Phase 3 clinical development. The program includes one completed Phase 3 trial. It is an investigational therapy and has not been approved by the FDA for any indication.
Acyclovir buccal/BAYM008894/UI1614773 has been evaluated in one Phase 3 clinical trial, NCT05098938. This completed study compared the acyclovir buccal tablet with placebo in the treatment of herpes labialis in participants with normal immune function. It enrolled 2,020 participants in the United States.
Acyclovir buccal/BAYM008894/UI1614773 is a small molecule antiviral. It is designed to deliver acyclovir locally via a buccal or topical tablet formulation. The mechanism of action targets herpes simplex virus replication, consistent with the antiviral activity of acyclovir.