Darolutamide is under clinical development by Orion and currently in Phase II for Salivary Gland Cancer. According to GlobalData, Phase II drugs for Salivary Gland Cancer have a 14% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Darolutamide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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, salivary gland carcinoma 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.

For a complete picture of Darolutamide’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

Premium Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.