Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
teverelix TFA · 2 trials · 2 indications
Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 28.
Area under the concentration time-curve from time zero up to the last measurable concentration at time point t Area under the concentration time-curve from time zero up to the last measurable concentration at time point t Area under the concentration time-curve from time zero up to the last measurable concentration at time point t
Area under the concentration time-curve from time zero up to concentration at time point t1 after which the concentrations start to rise again towards a second peak, t1 will be determined after review of the concentration-time profiles (immediate release component of total observed AUC)
Area under the concentration time-curve from time point t1 up to time point t (slow release component of total observed AUC)
Area under the concentration time-curve from time zero up to infinity (∞)
Maximum observed concentration after administration
Maximum observed concentration after administration from zero up to time point t1
Maximum observed concentration after administration from time point t1 up to time point t
Time to reach Cmax after dosing
Time to reach Cmax,0-t1 after dosing
Time to reach Cmax,t1-t after dosing
Apparent terminal rate constant
Apparent terminal plasma half-life
| Arm | Type | Description |
|---|---|---|
| Teverelix TFA 120 mg 6-weekly | EXPERIMENTAL | Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 |
| Teverelix TFA 180 mg 6-weekly | EXPERIMENTAL | Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 |
| 90 mg s.c. | EXPERIMENTAL | A single s.c. injection of 90 mg teverelix TFA administered on Day 1 |
| 60 mg s.c. | EXPERIMENTAL | A single s.c. injection of 60 mg teverelix TFA administered on Day 1 |
| 90 mg i.m. | EXPERIMENTAL | A single i.m. injection of 90 mg teverelix TFA administered on Day 1 |
| 120 mg s.c. | EXPERIMENTAL | A single s.c. injection of 120 mg teverelix TFA administered on Day 1 |
| Name | Type | Description |
|---|---|---|
| teverelix TFA 120 mg | DRUG | Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24 |
| teverelix TFA 180 mg | DRUG | Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24 |
| teverelix TFA | DRUG | A single s.c. or i.m. injection of teverelix TFA administered on Day 1 |
Inclusion Criteria: * Is male, aged ≤80 years (≥18 years) at the beginning of the treatment period (Day 0) * Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non metastatic hormone-sensitive non curative), suitable for ADT * Is treatment naïve for any of the followin...
Teverelix TFA is an investigational small molecule being studied for use in prostatic adenoma and in healthy volunteers. It is administered parenterally. The drug is currently in clinical development and is not approved by the FDA.
Teverelix TFA is being developed by Medicus Pharma Ltd., a company listed under the ticker MDCX. The drug is in Phase 1 clinical development.
Teverelix TFA is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy male volunteers and one Phase 2 trial in patients with prostatic adenoma.
Teverelix TFA has been studied in two completed trials. NCT03781947 was a Phase 1 study in healthy male volunteers in the United Kingdom, and NCT04693507 was a Phase 2 study in patients with prostatic adenoma in Lithuania.
Teverelix TFA is a specific formulation of teverelix, distinguished by the TFA salt form. The drug is being developed by Medicus Pharma Ltd. and is currently in clinical trials for prostatic adenoma.