Gonadotrophin Releasing Hormone — Competitive Intelligence Brief

Gonadotrophin Releasing Hormone (Gonadotrophin Releasing Hormone) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: GnRH agonist. Area: Oncology.

phase 3 GnRH agonist GnRH receptor Oncology Biologic

Target snapshot

Gonadotrophin Releasing Hormone (Gonadotrophin Releasing Hormone) — NRG Oncology. Gonadotropin-releasing hormone (GnRH) agonists stimulate the pituitary gland to release luteinizing hormone and follicle-stimulating hormone, which initially increases sex hormone production before causing downregulation and suppression of testosterone and estrogen.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Gonadotrophin Releasing Hormone TARGET	Gonadotrophin Releasing Hormone	NRG Oncology	phase 3	GnRH agonist	GnRH receptor
Lupron	leuprorelin	Accord Healthcare S.L.U.	marketed	Gonadotropin Releasing Hormone Receptor Agonist	GnRH receptors	1985-01-01
Micronor	norethisterone	Johnson & Johnson	marketed	Progestin	GnRH receptors	1962-01-01
COS with GnRH antagonists and HP-HMG	COS with GnRH antagonists and HP-HMG	Instituto Valenciano de Infertilidad, IVI VALENCIA	marketed	Gonadotropin protocol / Assisted reproductive technology regimen	GnRH receptor (antagonism); FSH receptor and LH receptor (agonism via exogenous gonadotropins)
Zoladex and Casodex	Zoladex and Casodex	AstraZeneca	marketed	GnRH agonist (Zoladex) and androgen receptor antagonist (Casodex)	GnRH receptor (Zoladex); androgen receptor (Casodex)
TRIPTORELIN ACETATE, hCG	TRIPTORELIN ACETATE, hCG	HaEmek Medical Center, Israel	marketed	GnRH agonist	GnRH receptor
GnRH agonist trigger	GnRH agonist trigger	Rambam Health Care Campus	marketed	GnRH agonist	GnRH receptor

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)

• 2028-03-22 — Lupron · 9617303 · US
• 2031-02-05 — Lupron · 8921326 · US

Sponsor landscape (GnRH agonist class)

1. Takeda · 4 drugs in this class
2. Abbott · 3 drugs in this class
3. Ipsen · 3 drugs in this class
4. Changchun GeneScience Pharmaceutical Co., Ltd. · 3 drugs in this class
5. University of Pisa · 2 drugs in this class
6. Chong Qing Reproducive and Genetic Institute · 1 drug in this class
7. Chesapeake Urology Research Associates · 1 drug in this class
8. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · 1 drug in this class
9. Enteris BioPharma Inc. · 1 drug in this class
10. Colorado Center for Reproductive Medicine · 1 drug in this class