Phase 2b Prostate Cancer Study Receives FDA Clearance in High-Risk Groups

The FDA has cleared a phase 2b trial evaluating teverelix trifluoroacetate (Teverelix), an investigational long-acting GnRH antagonist, among patients with advanced prostate cancer at a high cardiovascular (CV) risk, according to a news release from the developer, Medicus Pharma.¹

Specifically, investigators plan to enroll approximately 40 men in this group eligible to receive androgen deprivation therapy. Additionally, this agent is undergoing development specifically for this high CV risk group, including those who experienced recent major adverse cardiovascular events (MACE) or severe subclinical atherosclerosis, according to the developers. Additionally, high CV risk is measured as a coronary artery calcium (CAC) score greater than 400 in addition to an elevation in atherosclerotic cardiovascular disease (ASCVD) risk.

“[The] teverelix phase 2 dose optimization study in advanced prostate cancer represents an important transition point for the teverelix program,” Raza Bokhari, executive chairman and chief operating officer at Medicus, stated in the news release.¹ “Our development strategy is intentionally focused on a population that remains underserved by existing therapies. If successful, we believe teverelix has the potential to become a best-in-class GnRH antagonist and the first hormone therapy specifically supported by a cardiovascular-risk-focused label in this setting.”

Patients in the phase 2 study will receive a loading dose of the agent intramuscularly at 180 mg in addition to 2 additional subcutaneous infusions at 180 mg for a total of 540 mg. Afterward, patients will receive two 180 mg subcutaneous injections on day 29 of study treatment, as well as every 6 weeks thereafter. The total duration of treatment is planned for 22 weeks.

The developers engineered teverelix as a long-acting injectable GnRH antagonist formulated as a microcrystalline suspension. Providing immediate receptor antagonism, the agent enables expedient luteinizing hormone (LH), follicle-stimulating hormone (FSH), and downstream sex hormone suppression without flare-ups.

Additionally, investigators believe that for this elevated CV risk population, this mechanism may be clinically relevant by suppressing FSH exposure, which may contribute to MACE. Early trial data have shown that teverelix has not conferred significant CV safety signals.

The primary end point of the study will be confirmation of medical castration by day 29 of treatment, as well as sustained suppression through day 155. The target probability exceeds 90%.

A previous adaptive phase 2 study evaluated teverelix in advanced prostate cancer (NCT04993507).² Patients were treated in 2 experimental cohorts, which included intramuscular and subcutaneous teverelix loading doses at 120 mg or 180 mg followed by subcutaneous maintenance doses at 120 mg or 180 mg starting at week 6 and for every 6 weeks thereafter up to week 24.

The primary end point of the study was castration levels at 4 weeks of treatment. Secondary end points included testosterone levels, time to achieve castrate levels of testosterone, LH levels, FSH levels, and area under the concentration time-curve.

Those eligible for trial enrollment included men between 18 years and 80 years of age with histologically confirmed advanced adenocarcinoma of the prostate. Additional inclusion criteria included no previous treatment with GnRH analogues, androgen receptor antagonists, or androgen synthesis inhibitors.

Exclusion criteria included abnormal screening and/or baseline values suggesting a clinically significant underlying disease, any contraindications to teverelix use, a life expectancy of less than 1 year, and a medical history of bilateral orchidectomy. Moreover, those with testosterone levels below 2.0 ng/mL at screening; a neurological disease, psychiatric disease, or substance abuse that could interfere with treatment compliance; and those with a history of myocardial infarction were deemed ineligible to enroll on the trial.

References

1. Medicus Pharma receives FDA “study may proceed” clearance for Teverelix® phase 2b study in advanced prostate cancer patients with high cardiovascular risk. News release. Medicus Pharma. February 10, 2026. Accessed February 13, 2026. https://tinyurl.com/yc7mwv4m
2. Teverelix evaluated in advanced prostate cancer (TEACh). ClinicalTrials.gov. Updated July 23, 2024. Accessed February 13, 2026. https://tinyurl.com/5n7sv77w