Cyclo-Progynova — Competitive Intelligence Brief

Cyclo-Progynova (Cyclo-Progynova) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Hormone replacement therapy (HRT). Area: Gynecology / Endocrinology.

phase 3 Hormone replacement therapy (HRT) Estrogen receptor, Progesterone receptor Gynecology / Endocrinology Small molecule

Target snapshot

Cyclo-Progynova (Cyclo-Progynova) — El Shatby University Hospital for Obstetrics and Gynecology. Cyclo-Progynova is a cyclical hormone replacement therapy combining estrogen and progestin to replace declining hormones in menopausal women.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Cyclo-Progynova TARGET	Cyclo-Progynova	El Shatby University Hospital for Obstetrics and Gynecology	phase 3	Hormone replacement therapy (HRT)	Estrogen receptor, Progesterone receptor
Tibolone plus Xiangshao granules	Tibolone plus Xiangshao granules	Peking Union Medical College Hospital	marketed	Hormone replacement therapy (HRT) / Selective tissue estrogenic activity regulator (STEAR)	Estrogen receptor, Progesterone receptor, Androgen receptor
oral contraceptives	oral contraceptives	FHI 360	marketed	Hormonal contraceptive	Estrogen receptor, Progesterone receptor
Ethinyl estradiol / dienogest	Ethinyl estradiol / dienogest	Helsinki University Central Hospital	marketed	Combined oral contraceptive	Estrogen receptor, progesterone receptor
Microgestin®	Microgestin®	Ironwood Pharmaceuticals, Inc.	marketed	Oral contraceptive (combined estrogen-progestin)	Estrogen receptor, progesterone receptor
Add back therapy 1 (tibolone)	Add back therapy 1 (tibolone)	University of Cagliari	marketed	Selective Tissue Estrogenic Activity Regulator (STEAR); Hormone Replacement Therapy	Estrogen receptor, Progesterone receptor, Androgen receptor
fenofibrate and tibolone	fenofibrate and tibolone	Keogh Institute for Medical Research	marketed	Fibrate + Selective Estrogen Receptor Modulator (SERM)	PPAR-α (fenofibrate); Estrogen receptor, progesterone receptor, androgen receptor (tibolone)

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 (Hormone replacement therapy (HRT) class)

1. Anna Posadzy-Małaczyńska · 1 drug in this class
2. Beni-Suef University · 1 drug in this class
3. Brigham and Women's Hospital · 1 drug in this class
4. El Shatby University Hospital for Obstetrics and Gynecology · 1 drug in this class
5. Erasmus Medical Center · 1 drug in this class
6. Massachusetts General Hospital · 1 drug in this class
7. Myovant Sciences GmbH · 1 drug in this class
8. Peking Union Medical College Hospital · 1 drug in this class
9. Scientific Research Institute of Public Health, Russian Federation · 1 drug in this class
10. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · 1 drug in this class