Darolutamide is a Small Molecule owned by Orion, and is involved in 46 clinical trials, of which 16 were completed, 22 are ongoing, and 8 are planned.

Darolutamide is an androgen receptor inhibitor with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

Darolutamide (ODM-201, BAY-1841788) is a formulation containing an androgen receptor (AR) antagonist with potential antineoplastic activity. AR antagonist ODM-201 binds to ARs in target tissues; subsequently, inhibiting androgen-induced receptor activation and facilitating the formation of inactive complexes that cannot translocate to the nucleus. This prevents binding to and transcription of AR-responsive genes that regulate prostate cancer cell proliferation. This ultimately leads to an inhibition of growth in AR-expressing prostate cancer cells.

The revenue for Darolutamide is expected to reach a total of $3.2bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Darolutamide NPV Report.

Darolutamide is originated and owned by Orion. Bayer is the other company associated in development or marketing of Darolutamide.

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.

The company reported revenues of (Euro) EUR1,041 million for the fiscal year ended December 2021 (FY2021), a decrease of 3.4% over FY2020. In FY2021, the company’s operating margin was 23.4%, compared to an operating margin of 26% in FY2020. In FY2021, the company recorded a net margin of 18.6%, compared to a net margin of 20.4% in FY2020. The company reported revenues of EUR491.8 million for the third quarter ended September 2022, an increase of 73.4% over the previous quarter.

Quick View – Darolutamide

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

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.