Orion's R&D Pipeline

Clinical pharmaceutical development projects

• Darolutamide » prostate cancer (mHSPC) » Registration

  Indication:

  Metastatic hormone-sensitive prostate cancer (mHSPC)

  Status:

  The Phase III study ARANOTE (2021-2024) results were published in September 2024 LINK TO NEWS. 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

  Link: ARANOTE trial on clinicaltrials.gov

• Darolutamide » prostate cancer (BCR) » Phase III ARASTEP

  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

  Link: ARASTEP trial on clinicaltrials.gov

• Opevesostat » prostate cancer (mCRPC) » Phase III OMAHA1

  Indication:

  Metastatic castration-resistant prostate cancer (mCRPC)

  Status:

  The Phase III study OMAHA1 is ongoing (2023-).  The study evaluates the safety, tolerability and efficacy of ODM-208/MK-5684 in combination with HRT for the treatment of patients with later-line mCRPC who have failed one prior new hormonal agent (NHA) and one or two prior taxane-based chemotherapies.

  Primary outcome measures: 

  Overall survival (OS) and radiographic progression-free survival (rPFS) by AR LBD mutation status.

  Partner:

  Trial conducted by Orion's partner MSD/Merck with global exclusive rights to opevesostat.

  LINK: OMAHA1 trial on clinicaltrials.gov

• Opevesostat » prostate cancer (mCRPC) » Phase III OMAHA2a

  Indication:

  Metastatic castration-resistant prostate cancer (mCRPC)

  Status:

  The Phase III study OMAHA2a is ongoing (2023-).  The study evaluates the safety, tolerability and efficacy of ODM-208/MK-5684 in combination with HRT for the treatment of patients with front-line mCRPC who have failed one prior NHA.

  Primary outcome measures: 

  Overall survival (OS) and radiographic progression-free survival (rPFS) by AR LBD mutation status.

  Partner:

  Trial conducted by Orion's partner MSD/Merck with global exclusive rights to opevesostat.

  LINK: OMAHA2a trial on clinicaltrials.gov

• Opevesostat » prostate cancer (mCRPC) » Phase II CYPIDES

  Indication:

  Metastatic castration-resistant prostate cancer (mCRPC)

  Status:

  The Phase II study CYPIDES is ongoing (2018-)  The study evaluates the safety and tolerability of the drug candidate in prostate cancer patients.

  Primary outcome measures: 

  Maximum tolerated dose.

  Partner:

  Orion's partner MSD/Merck has global exclusive rights to opevesostat.

  Link: CYPIDES trial on clinicaltrials.gov

• ODM-105 (tasipimidine) » insomnia » Phase IIa

  Indication:

  Insomnia

  Status:

  Orion has an ongoing Phase IIa clinical trial with tasipimidine for the treatment of insomnia, which is often associated with pain and difficult to treat.

• ODM-212 » solid tumours »

  Indication:

  Cancer / solid tumours

  Status:

  Orion has ongoing a Phase I clinical trial with ODM-212 molecule, which is a TEAD inhibitor aimed for the treatment of solid tumours with YAP/TEAD activation. The study evaluates the safety and tolerability of ODM-212.