R&D pipeline

Clinical pharmaceutical development projects

• 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

• Darolutamide » prostate cancer » Phase III DASL-HiCaP (Bayer trial)

  Orion’s partner Bayer has an ongoing DASL-HiCaP Phase III trial which evaluates darolutamide as a treatment for localized prostate cancer in combination with radiotherapy.

  Partner:

  Trial conducted by Orion’s partner Bayer.

  Further info about DASL-HiCaP trial on clinicaltrials.gov

• Opevesostat » prostate cancer (mCRPC) » Phase III OMAHA-003 (MSD trial)

  Indication:

  Metastatic castration-resistant prostate cancer (mCRPC)

  Status:

  The Phase III study OMAHA-003 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 measure: 

  Overall survival (OS) by AR LBD mutation status.

  Partner:

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

  LINK: OMAHA-003 trial on clinicaltrials.gov

• Opevesostat » prostate cancer (mCRPC) » Phase III OMAHA-004 (MSD trial)

  Indication:

  Metastatic castration-resistant prostate cancer (mCRPC)

  Status:

  The Phase III study OMAHA-004 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 measure: 

  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: OMAHA-004 trial on clinicaltrials.gov

• LEVEL-2 (TNX-103/levosimendan) » pulmonary hypertension (PH-HFpEF) » Phase III LEVEL (Tenax trial)

  Indication:

  Pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF).

  Status:

  LEVEL Phase III trial is ongoing by Orion's partner Tenax Therapeutics.

  Partner:

  Trial conducted by Orion's partner Tenax Therapeutics.

  LINK: LEVEL trial on clinicaltrials.gov

• Opevesostat » prostate cancer (mCRPC) » Phase II MK-5684-01A (MSD trial)

  Orion’s collaborator MSD has an ongoing Phase II trial (MK-5684-01A) which evaluates opevesostat alone and in combination with other treatments in patients with metastatic castration-resistant prostate cancer.

  Partner:

  Trial conducted by Orion's collaborator MSD with global exclusive rights to opevesostat.

  Further info on clinicaltrials.gov

• Opevesostat » certain women’s cancers » Phase II OMAHA-015 (MSD trial)

  Orion’s collaborator MSD has an ongoing Phase II trial (OMAHA-015) which evaluates opevesostat in patients with breast, endometrial or ovarian cancer.

  Partner:

  Trial conducted by Orion's collaborator MSD with global exclusive rights to opevesostat.

  Further info 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. Orion conducts CYPIDES trial.

  Link: CYPIDES trial on clinicaltrials.gov

• ODM-212 » solid tumours » Phase II TEADES

  Indication:

  Cancer / malignant pleural mesothelioma (MPM), epithelioid hemangioendothelioma (EHE) and solid tumours 

  Status:

  Orion has an ongoing Phase II 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.

  Further info: Press release on 8 January 2026

  Link: TEADES trial on clinicaltrials.gov

• ODM-212 » solid tumours » Phase Ib/II TEADCO

  Indication:

  Mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer in combination with standard of care treatments.  

  Status:

  Orion has ongoing a Phase Ib/II clinical trial with ODM-212 molecule, which is a TEAD inhibitor aimed for the treatment of solid tumours with YAP/TEAD activation. 

  Further info: Press release on 23 April 2026

   

• ODM-216 » advanced solid tumours » Phase I/II BICIDES

  Status:

  Orion has an ongoing Phase I/II clinical trial called BICIDES with ODM-216, an investigational bispecific antibody simultaneously targeting PVRIG and PD-L1, two immune-regulatory pathways involved in cancer growth and progression. The study evaluates the safety, pharmacokinetics and preliminary anti-tumor activity of ODM-216.

  ODM-216 is part of Orion’s immuno-oncology portfolio, including several assets in the pre-clinical pipeline. 

  Further info: Press release on 5 October 2026 

  Link: BICIDES trial on clinicaltrials.gov