Darolutamide intermittent — Competitive Intelligence Brief

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

phase 3 Androgen receptor antagonist Androgen receptor (AR) Oncology Small molecule

Target snapshot

Darolutamide intermittent (Darolutamide intermittent) — The First Affiliated Hospital with Nanjing Medical University. Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting prostate cancer cell growth and survival.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Darolutamide intermittent TARGET	Darolutamide intermittent	The First Affiliated Hospital with Nanjing Medical University	phase 3	Androgen receptor antagonist	Androgen receptor (AR)
ODM-201 Tablet A	ODM-201 Tablet A	Orion Corporation, Orion Pharma	marketed	Androgen receptor antagonist	Androgen receptor (AR)
Darolutamide Oral Tablet	Darolutamide Oral Tablet	Santa Chiara Hospital	marketed	Androgen receptor antagonist	Androgen receptor (AR)
Zoladex and Casodex	Zoladex and Casodex	AstraZeneca	marketed	GnRH agonist (Zoladex) and androgen receptor antagonist (Casodex)	GnRH receptor (Zoladex); androgen receptor (Casodex)
Maximum androgen blockade	Maximum androgen blockade	Wonju Severance Christian Hospital	marketed	Androgen receptor antagonist combination therapy	Androgen receptor; testosterone synthesis pathway
Abiraterone with Prednisone or Enzalutamide	Abiraterone with Prednisone or Enzalutamide	Curium US LLC	phase 3	CYP17A1 inhibitor (abiraterone) + androgen receptor antagonist (enzalutamide) + glucocorticoid (prednisone)	CYP17A1 (abiraterone); androgen receptor (enzalutamide); glucocorticoid receptor (prednisone)
Androgen blockade + radiation therapy	Androgen blockade + radiation therapy	Université de Sherbrooke	phase 3	Androgen receptor antagonist + radiation therapy (combination)	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