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Darolutamide Oral Tablet — Competitive Intelligence Brief

Darolutamide Oral Tablet (Darolutamide Oral Tablet) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Androgen receptor antagonist. Area: Oncology.

marketed Androgen receptor antagonist Androgen receptor (AR) Oncology Small molecule Live · refreshed every 30 min

Target snapshot

Darolutamide Oral Tablet (Darolutamide Oral Tablet) — Santa Chiara Hospital. Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting androgen-driven prostate cancer cell growth.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Darolutamide Oral Tablet TARGET Darolutamide Oral Tablet Santa Chiara Hospital marketed Androgen receptor antagonist Androgen receptor (AR)
Maximum androgen blockade Maximum androgen blockade Wonju Severance Christian Hospital marketed Androgen receptor antagonist combination therapy Androgen receptor; testosterone synthesis pathway
Zoladex and Casodex Zoladex and Casodex AstraZeneca marketed GnRH agonist (Zoladex) and androgen receptor antagonist (Casodex) GnRH receptor (Zoladex); androgen receptor (Casodex)
ODM-201 Tablet A ODM-201 Tablet A Orion Corporation, Orion Pharma marketed Androgen receptor antagonist Androgen receptor (AR)
Apalutamide Oral Tablet Apalutamide Oral Tablet Santa Chiara Hospital phase 3 Androgen receptor antagonist Androgen receptor (AR)
Abiraterone Acetate or Enzalutamide Abiraterone Acetate or Enzalutamide National Cancer Institute, Naples phase 3 Androgen synthesis inhibitor (abiraterone) / Androgen receptor antagonist (enzalutamide) CYP17A1 (abiraterone) / Androgen receptor (enzalutamide)
Darolutamide (BAY 1841788) Darolutamide (BAY 1841788) Canadian Cancer Trials Group phase 3 Non-steroidal androgen receptor antagonist Androgen receptor (AR)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Androgen receptor antagonist class)

  1. Santa Chiara Hospital · 2 drugs in this class
  2. Cassiopea SpA · 2 drugs in this class
  3. The First Affiliated Hospital with Nanjing Medical University · 2 drugs in this class
  4. Pfizer · 2 drugs in this class
  5. Suzhou Kintor Pharmaceutical Inc, · 1 drug in this class
  6. AEterna Zentaris · 1 drug in this class
  7. University of Sydney · 1 drug in this class
  8. CHU de Quebec-Universite Laval · 1 drug in this class
  9. Jiangsu HengRui Medicine Co., Ltd. · 1 drug in this class
  10. Orion Corporation, Orion Pharma · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Darolutamide Oral Tablet — Competitive Intelligence Brief. https://druglandscape.com/ci/darolutamide-oral-tablet. Accessed 2026-05-16.

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