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Histrelin hydrogel · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Zoladex goserelin implant. | ACTIVE_COMPARATOR | Zoladex goserelin implant: D, L-lactic and glycolic acids copolymer. Injected subcutaneously into the upper abdominal wall. |
| Histrelin Acetate implant | EXPERIMENTAL | Histrelin hydrogel implant, 3 cm x 3.5 mm, containing 50 mg of histrelin acetate, surgically placed subdermally into the inner aspect of the upper arm. |
| Name | Type | Description |
|---|---|---|
| Histrelin hydrogel implant | DRUG | 50 mg histrelin acetate in hyrogel implant |
| Zoladex goserelin implant | DRUG | goserelin implant injection. |
Key Inclusion Criteria: * Male patients with histologically confirmed adenocarcinoma of the prostate * Disease staging of M1 or apparent failure of the initial definitive therapy (e.g., prostatectomy, radiation, etc.), suggested by either an elevated PSA (5 ng/mL or greater within the previous 28 d...
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Histrelin hydrogel is used for the treatment of prostate cancer, specifically adenocarcinoma of the prostate. It is an investigational small molecule being developed by BrainsWay Ltd. The drug is administered as a subdermal implant and is currently in Phase 3 clinical development.
Histrelin hydrogel is a small molecule that works by targeting the gonadotropin-releasing hormone pathway. It is designed to suppress testosterone production, which can help slow the growth of prostate cancer cells. The drug is delivered via a subdermal implant for sustained release.
Histrelin hydrogel is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is currently in Phase 3 clinical trials for the treatment of prostate cancer. BrainsWay is conducting research to evaluate the safety and efficacy of this subdermal implant.
Histrelin hydrogel is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 clinical trial has been completed to evaluate its use in patients with prostate cancer, including adenocarcinoma of the prostate.
Histrelin hydrogel has been studied in a Phase 3 clinical trial with the identifier NCT01394263, titled 'Study of Histrelin Subdermal Implant in Patients With Prostate Cancer.' This completed trial enrolled 59 male patients aged 45 years and older with prostate cancer. The trial was active-controlled and randomized, though not double-blinded.
Histrelin hydrogel is a formulation of histrelin, a gonadotropin-releasing hormone agonist. The hydrogel form is designed for subdermal implantation to provide sustained release of the drug. While histrelin is the active pharmaceutical ingredient, the hydrogel formulation is a specific delivery system being studied for prostate cancer.