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Also known as GS-9191 ointment
GS-9191 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | GS-9191 0.01% ointment |
| Cohort 2 | EXPERIMENTAL | GS-9191 0.03% ointment |
| Cohort 3 | EXPERIMENTAL | GS-9191 0.1% ointment |
| Cohort 4 | ACTIVE_COMPARATOR | GS-9191 0.3% |
| Cohort 5 | ACTIVE_COMPARATOR | GS-9191 1.0% |
| Cohorts 1, 2, 3, 4 & 5 | PLACEBO_COMPARATOR | Placebo in all cohorts |
| Name | Type | Description |
|---|---|---|
| GS-9191 ointment | DRUG | GS-9191 ointment (0.01%, 0.03%, or 0.1%) or placebo applied topically to anogenital warts for one or three cycles, each cycle lasting 5 consecutive nights of ointment application followed by 9 nights off-ointment. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort. |
| GS-9191 | DRUG | GS-9191 ointment (0.3% or 1.0%) or placebo applied topically to anogenital warts for one or three cycles; each cycle consists of dosing occuring over a 5-night period with ointment application on nights 1, 3 and 5 followed by a 9-day off-ointment period. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort. |
| Placebo | DRUG | Placebo matching GS-9191 ointment |
Inclusion Criteria: * Have 2 or more genital warts of prespecified sizes on external surfaces of the body. * If HIV positive, have HIV RNA \< 400 copies/mL, CD4 count of ≥ 400 cells/mm3, and be taking a triple combination antiviral medication regimen Exclusion Criteria: * Prior genital wart treat...
GS-9191 is an investigational small molecule developed by Gilead Sciences, Inc. (ticker GILD) as a topical ointment for the treatment of genital warts. It is in Phase 1 clinical development and has not been approved by the FDA. It is also known as GS-9191 ointment.
GS-9191 is being studied for the treatment of genital warts, a condition in the infectious disease therapeutic area. It is formulated as a topical ointment applied directly to affected areas. The program remains investigational, and no approved indication exists for GS-9191 at this stage of development.
GS-9191 is made and developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating the drug as a topical treatment for genital warts.
GS-9191 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 program has been completed, and no trials are currently active.
GS-9191 has been evaluated in one completed Phase 1 trial, NCT00499967, titled "Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts." The trial enrolled 202 participants in the United States, was randomized, double blind, and placebo controlled, and included adults 18 years and older.
Yes, GS-9191 ointment is another name for GS-9191. Both refer to the same investigational topical formulation developed by Gilead Sciences, Inc. (ticker GILD) for the treatment of genital warts. The ointment designation describes the topical dosage form used in the Phase 1 clinical program.