Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of prostate cancer and benign prostatic hypertrophy (BPH), a condition involving enlargement of the prostate. It is in Phase 2 clinical development and has not been approved by regulatory authorities.
Ozarelix is a small molecule that targets the luteinizing hormone-releasing hormone (LHRH) receptor, also known as the gonadotropin-releasing hormone receptor. By acting on this target, it is intended to modulate hormone signaling relevant to prostate conditions.
Ozarelix is being developed by Assertio Holdings, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ASRT on the NASDAQ exchange.
Ozarelix is currently in Phase 2 clinical development. It has completed two Phase 2 trials, one in benign prostatic hypertrophy and one in prostate cancer. It is not yet approved and remains an investigational drug.
Ozarelix has been studied in two completed Phase 2 trials. NCT00427219 evaluated its safety and efficacy in 74 men with benign prostatic hypertrophy. NCT01252693 assessed a monthly dosing regimen versus goserelin depot in 203 men with prostate cancer.
No, Ozarelix is not the same as goserelin. In a clinical trial, Ozarelix was compared against goserelin depot, which is a different drug used as an active comparator in men with prostate cancer. Ozarelix is a distinct investigational compound.