Investigational Drug
Debio 4228
TrialFetch AI Analysis
Show TrialFetch AI Analysis
Overview
Debio 4228 is an investigational extended-release formulation of degarelix being studied as an intramuscular injection for prostate cancer. Degarelix itself has been studied and used in a different, monthly formulation; results from that formulation should not be taken as results for Debio 4228. (clinicaltrials.gov)
Mechanism of action
Degarelix blocks the gonadotropin-releasing hormone (GnRH) receptor, suppressing hormones that stimulate testosterone production. In studies of the established degarelix formulation, testosterone fell without the initial surge associated with GnRH agonists. (accessdata.fda.gov)
Clinical evidence
No human efficacy or safety results for Debio 4228 were found. A phase 2 dose-finding study enrolled 55 participants and is measuring drug exposure, testosterone suppression, and adverse events; its ClinicalTrials.gov record lists no results posted. Consequently, response rates and formulation-specific safety rates are not yet available. (clinicaltrials.gov)
Further reading
- Debio 4228 phase 2 study record (clinicaltrials.gov)
- Peer-reviewed phase 3 study of the established degarelix formulation (pubmed.ncbi.nlm.nih.gov)
Last updated: Sep 2026
Active trials using Debio 4228
Found 4 active trials using this drug:
TrialFetch AI summary: Adults with metachronous recurrent oligometastatic hormone-sensitive prostate cancer (≤5 metastases, including at least one beyond the pelvis) receive SBRT to metastases, then either observation or six months of androgen deprivation therapy plus an androgen receptor pathway inhibitor (abiraterone/prednisone, apalutamide, darolutamide, or enzalutamide) before observation.
ClinicalTrials.gov ID: NCT06378866
TrialFetch AI summary: Men with metastatic castration-sensitive prostate adenocarcinoma who have not received chemotherapy or treatment intensification for metastatic disease receive talazoparib, a PARP inhibitor, plus ADT, abiraterone, and prednisone. Prior recent initiation of ADT is permitted.
ClinicalTrials.gov ID: NCT04734730
TrialFetch AI summary: Men with biochemical recurrence after prostatectomy who are eligible for salvage prostate-bed and pelvic-node radiation plus six months of ADT are assigned by PET findings to treatment comparisons. Those without extrapelvic PET lesions receive standard treatment with or without apalutamide, an androgen-receptor inhibitor; those with extrapelvic PET lesions receive standard treatment plus apalutamide with or without metastasis-directed radiation.
ClinicalTrials.gov ID: NCT04423211
TrialFetch AI summary: Patients with metastatic prostate adenocarcinoma, an intact and surgically resectable prostate, and no progression after 22–28 weeks of systemic therapy are randomized to continue standard systemic therapy alone or add definitive treatment of the primary tumor with prostatectomy or radiation.
ClinicalTrials.gov ID: NCT03678025
