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 $19.7bn 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.

Bayer Overview

Bayer is engaged in the discovery, development, manufacturing, and commercialization of products for human health, and agriculture. It provides medicines for cardiovascular diseases, women’s health, cancer, hematology, ophthalmology and other indications. It also strives to develop new molecules and technologies for use in the fields of medicine and modern agriculture. The company’s product portfolio includes prescription products, specialty pharmaceuticals, diagnostic imaging equipment, non-prescription (over the counter or OTC) products, seeds, crop protection solutions and non-agricultural pest control solutions. Bayer markets its healthcare and crop protection products essentially through wholesalers, pharmacies, hospitals and retailers. It operates through a network of subsidiaries in Asia-Pacific, Europe, North America, Latin America, Africa and the Middle East. Bayer is headquartered in Leverkusen, North Rhine-Westphalia, Germany.

The company reported revenues of (Euro) EUR44,081 million for the fiscal year ended December 2021 (FY2021), an increase of 6.5% over FY2020. The operating profit of the company was EUR3,353 million in FY2021, compared to an operating loss of EUR16,169 million in FY2020. The net profit of the company was EUR1,000 million in FY2021, compared to a net loss of EUR10,495 million in FY2020. The company reported revenues of EUR11,281 million for the third quarter ended September 2022, a decrease of 12% 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.