Indication:
Metastatic hormone-sensitive prostate cancer (mHSPC)
Status:
The Phase III study ARANOTE is ongoing (2021-) The study evaluates darolutamide in combination with hormonal therapy (androgen deprivation therapy) in patients with metastatic hormone sensitive prostate cancer.
Primary outcome measures:
Radiological progression-free survival
Secondary outcome measures:
Overall survival
Partner:
Bayer
Indication:
Hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR).
Status:
The Phase III study ARASTEP is ongoing (2023-) The study evaluates the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.
Primary outcome measures:
Radiological progression-free survival (rPFS), measured by PSMA PET/CT assessed by independent central review.
Partner:
Bayer
Indication:
Metastatic castration-resistant prostate cancer (mCRPC)
Status:
The Phase II study CYPIDES is ongoing (2018-) The study evaluates he safety and tolerability of the drug candidate in prostate cancer patients.
Primary outcome measures:
Maximum tolerated dose
Partner:
MSD
Indication:
Psychiatric disorders
Status:
Orion is preparing to start a Phase II clinical trial to investigate the efficacy and safety of ODM-105 in psychiatric disorders
Indication:
Acute and chronic pain
Status:
The ongoing Phase I trial will investigate the tolerability and safety of the drug candidate in healthy volunteers
