Darolutamide continuous — Competitive Intelligence Brief

Darolutamide continuous (Darolutamide continuous) 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 continuous (Darolutamide continuous) — 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 androgen-driven prostate cancer cell growth.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Darolutamide continuous TARGET	Darolutamide continuous	The First Affiliated Hospital with Nanjing Medical University	phase 3	Androgen receptor antagonist	Androgen receptor (AR)
Darolutamide Oral Tablet	Darolutamide Oral Tablet	Santa Chiara Hospital	marketed	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)
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)
ADT+second-generation antiandrogens ± chemotherapy	ADT+second-generation antiandrogens ± chemotherapy	The First Affiliated Hospital with Nanjing Medical University	phase 3	Androgen deprivation therapy + androgen receptor antagonist ± chemotherapy	Androgen receptor; testosterone/DHT synthesis (if abiraterone included)
Placebo plus enzalutamide	Placebo plus enzalutamide	Pfizer	phase 3	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