Darolutamide is under clinical development by Orion and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Darolutamide’s likelihood of approval (LoA) and phase transition for Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer took place on 19 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Darolutamide Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Darolutamide overview

Darolutamide (Nubeqa) is a nonsteroidal antiandrogen with potential anti neoplastic activity. It is formulated as film coated tablets and tablets for oral route of administration. Nubeqa is indicated for the treatment of  non-metastatic castration-resistant prostate cancer. Nubeqa is indicated in combination with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

Darolutamide (ODM-201, BAY-1841788) is under development for the treatment of prostate adenocarcinoma, metastatic prostate cancer, metastatic hormone-sensitive prostate cancer, non-metastatic castrate resistant prostate cancer, adenocarcinoma of prostate and triple negative breast cancer. The drug candidate is administered orally as a tablet. ODM-201 binds to androgen receptor (AR). it is a new molecular entity.

Orion overview

Orion develops, manufactures and markets human and veterinary pharmaceuticals, and active pharmaceutical ingredients (APIs). Its products include pharmaceuticals for the treatment of central nervous system disorders, cancer, and respiratory diseases. The company’s pipeline encompasses investigational candidates for the treatment of amyotrophic lateral sclerosis, Parkinson’s disease, chronic obstructive pulmonary disease, and various cancer types. Orion’s client base consists of healthcare service providers and professionals, such as doctors, pharmacies, veterinarians, hospitals, healthcare centers, clinics, and laboratories. The company sells its products in European markets through own sales network and in international markets through several partners and distributors. Orion is headquartered in Espoo, Finland.

Quick View Darolutamide LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Darolutamide
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.