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GSK5458514 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose escalation of GSK5458514 monotherapy | EXPERIMENTAL | - |
| Part 2: Dose expansion of GSK5458514 monotherapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK5458514 | DRUG | GSK5458514 will be administered. |
Inclusion Criteria: * Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Male participants ≥18 years of age (or the legal age of consent in the jurisd...
GSK5458514 is an investigational small molecule being studied for the treatment of prostate cancer, specifically for neoplasms of the prostate. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
GSK5458514 is being developed by GSK plc, a global biopharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with prostate cancer.
GSK5458514 is currently in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and preliminary efficacy of the drug in participants with prostate cancer. The drug is investigational and has not been approved for commercial use.
GSK5458514 is being evaluated in a Phase 1 clinical trial registered as NCT06990880. This study, which is currently recruiting participants, is investigating the drug administered alone or in combination with other anti-cancer agents in patients with prostate cancer. The trial is expected to enroll approximately 85 participants across the United States, Canada, France, Japan, and Spain.
No, GSK5458514 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for prostate cancer. The drug has not yet completed the clinical development process required to obtain regulatory approval from the FDA or other health authorities.