Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Teverelix DP · 2 trials · 4 indications
Percent change from baseline in total prostate volume as assessed by transrectal ultrasound.
Castration rate defined as the cumulative probability of testosterone suppression to \< 0.5 ng/mL with the lower bound of the 95% confidence interval (CI) being \> 90%
| Arm | Type | Description |
|---|---|---|
| Teverelix DP 90 mg IM | ACTIVE_COMPARATOR | - |
| Teverelix DP 120 mg SC | ACTIVE_COMPARATOR | - |
| Teverelix DP placebo 90 mg IM | PLACEBO_COMPARATOR | - |
| Teverelix DP placebo 120 mg SC | PLACEBO_COMPARATOR | - |
| Teverelix DP 180 mg | EXPERIMENTAL | Participants receive teverelix DP loading dose on Day 1 (180 mg IM + 2x 180 mg SC) then teverelix DP 2x 180 mg SC on Day 29 and every 6 weeks to Week 16 (Day 113) |
| Name | Type | Description |
|---|---|---|
| Teverelix DP | DRUG | Single dose at Day 1 of 90 mg injection IM |
| Teverelix DP Placebo | DRUG | Single dose at Day 1 of 90 mg injection IM |
| Teverelix DP 180 mg | DRUG | Teverelix DP 540 mg Day 1 and 360 mg every 6 weeks from week 4 to week 16. |
Inclusion Criteria: 1. Male aged 45 years or older 2. Having given his written consent 3. Successful TWOC as defined by successful voiding with a minimum residual volume 4. Having had a first episode of spontaneous acute urinary retention within 6 days of study screening visit. 5. Prostate volume \...
Teverelix DP is an investigational small molecule being developed for advanced prostate cancer and acute urinary retention. It is a gonadotropin-releasing hormone (GnRH) antagonist. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Teverelix DP targets the gonadotropin-releasing hormone (GnRH) receptor. As a GnRH antagonist, it is designed to suppress the release of gonadotropins, which can influence hormone levels relevant to prostate cancer and urinary retention. The drug is being studied in male patients with these conditions.
Teverelix DP is being developed by Medicus Pharma Ltd., a company listed on the stock exchange under the ticker MDCX. The developer is conducting Phase 2 clinical trials to evaluate the drug's pharmacokinetics, pharmacodynamics, efficacy, and safety in patients with advanced prostate cancer and acute urinary retention.
Teverelix DP is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 2 trials are planned, both with a status of not yet recruiting. The drug is being studied for advanced prostate cancer and acute urinary retention.
Teverelix DP is involved in two Phase 2 clinical trials. NCT07457164 is studying the drug in patients with advanced prostate cancer, with an enrollment of 40 participants. NCT07733934 is investigating its effects on prostate volume and urinary function following acute urinary retention, with an enrollment of 126 participants. Both trials are randomized, double-blind, and placebo-controlled.