Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational Treatment · 2 trials · 2 indications
Number of participants achieving complete clearance of genital warts at Week 14
Number of participants with at least one AE/SAE in the category up to 30 weeks
Number of participants with at least one AE/SAE in the category up to 20 weeks
Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
| Arm | Type | Description |
|---|---|---|
| LFX453 0.1% NMC | EXPERIMENTAL | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
| LLFX453 0.15% LCC | EXPERIMENTAL | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
| Vehicle to NMC | PLACEBO_COMPARATOR | Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
| Vehicle to LCC | PLACEBO_COMPARATOR | Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
| Aldara | ACTIVE_COMPARATOR | Aldara 5% cream 3 applications per week for a maximum of 16 weeks |
| LFX453 0.15% LCC | EXPERIMENTAL | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications |
| Name | Type | Description |
|---|---|---|
| Investigational Treatment | DRUG | Applied twice daily for up to 12 weeks |
| Aldara | DRUG | Applied 3 times a week for 16 weeks |
| Active comparator | DRUG | Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up. |
Inclusion Criteria: * Signed informed consent * Circumcised male 18-60 years * Clinical diagnosis of external genital warts * Agree to remain abstinent or to use condoms during intercourse for the duration of the study * Agree to digital photographs of treated area Exclusion Criteria: * Any treat...
LFX453 is an investigational small molecule being studied for the treatment of external genital warts and actinic keratosis, both dermatological conditions. It is being developed by Novartis AG (NVS) and is currently in Phase 2 clinical development.
The specific molecular target of LFX453 has not been disclosed. It is a small molecule being investigated for its effects on external genital warts and actinic keratosis, with clinical trials evaluating its safety, tolerability, and efficacy in these conditions.
LFX453 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for dermatological indications.
LFX453 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in actinic keratosis and one in external genital warts. The drug is investigational and has not been approved by regulatory authorities.
LFX453 has been studied in two completed Phase 2 trials. NCT02404389 evaluated the drug in 82 patients with actinic keratosis across Austria, Denmark, Germany, Iceland, and the United Kingdom. NCT02482428 assessed the drug in 88 male patients with external genital warts in the United States.
LFX453 is the primary name used for this investigational compound in clinical trials. No alternative names have been reported for this drug in the available clinical trial information.