Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed by Gilead Sciences for the treatment of genital warts, a condition caused by human papillomavirus infection. It is designed as a topical ointment for this indication.
GS-9191 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in clinical development for genital warts.
GS-9191 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety and effectiveness.
GS-9191 has one completed clinical trial, identified as NCT00499967. This Phase 1 study, titled 'Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts,' enrolled 202 participants in the United States.
Yes, GS-9191 is a small molecule drug. It is formulated as a topical ointment for the treatment of genital warts, and it is being developed by Gilead Sciences.