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Ozarelix · 2 trials · 2 indications
IPSS is a validated self-administered index for grading benign prostatic hyperplasia (BPH)-related signs and symptoms. It consists of a set of seven questions. A total score of 1-7 indicates mild disease, 8-19 moderate disease and 20-35 severe disease.
| Arm | Type | Description |
|---|---|---|
| Ozarelix | EXPERIMENTAL | - |
| Goserelin | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received placebo Day 0 and Day 14. |
| Name | Type | Description |
|---|---|---|
| Ozarelix | DRUG | Ozarelix Loading dose of 130 mg SC at randomization will be followed by maintenance dosing of 65 mg SC at day 8, 28 and 56. |
| Goserelin | DRUG | Goserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56. |
| Placebo | DRUG | Placebo will be administered IM on Day 0 and Day 14. |
Inclusion Criteria: * Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated. * Screening testosterone \> 1.5 ng/ml * Life expectancy of at least 12 months * ECOG score of ≤ 2 * Patient has reviewed and signed Informed c...
Ozarelix is an investigational small molecule developed by Assertio Holdings, Inc. (ticker ASRT) for urology conditions. It has been studied in Phase 2 clinical trials for benign prostatic hypertrophy and prostate cancer. It is not approved and remains in clinical development.
Ozarelix has been studied in Phase 2 for benign prostatic hypertrophy, specifically to treat men with lower urinary tract symptoms due to enlargement of the prostate. It is investigational and not approved for this or any other use.
Ozarelix targets GNRHR, the gonadotropin-releasing hormone receptor, and acts as an antagonist. By blocking this receptor, it is designed to suppress the hormonal signaling that drives prostate growth and prostate cancer cell activity.
Ozarelix is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company has sponsored Phase 2 studies of the drug in prostate cancer and benign prostatic hypertrophy.
Ozarelix is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Two completed Phase 2 trials have evaluated it, and no active trials are currently listed.
Ozarelix has been evaluated in two completed Phase 2 trials. NCT01252693 compared monthly Ozarelix with goserelin depot in men with prostate cancer, enrolling 203 patients. NCT00427219 studied Ozarelix in men with lower urinary tract symptoms due to prostate enlargement, enrolling 74 patients.