Tibolone (Livial) — Competitive Intelligence Brief

Tibolone (Livial) (Tibolone (Livial)) competitive landscape: 5 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Selective tissue estrogenic activity regulator (STEAR); synthetic steroid. Area: Endocrinology / Menopause.

marketed Selective tissue estrogenic activity regulator (STEAR); synthetic steroid Estrogen receptor, progesterone receptor, androgen receptor Endocrinology / Menopause Small molecule

Target snapshot

Tibolone (Livial) (Tibolone (Livial)) — Wyeth is now a wholly owned subsidiary of Pfizer. Tibolone is a synthetic steroid that acts as a selective tissue estrogenic activity regulator (STEAR), providing estrogenic, progestagenic, and androgenic effects to alleviate menopausal symptoms.

Comparator set (5 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Tibolone (Livial) TARGET	Tibolone (Livial)	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	Selective tissue estrogenic activity regulator (STEAR); synthetic steroid	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)
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
ethinyl estradiol and cyproterone acetate	ethinyl estradiol and cyproterone acetate	S.C.B. Medical College and Hospital	marketed	Combined oral contraceptive with anti-androgenic activity	Estrogen receptor, progesterone receptor, androgen 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
Black Cohosh (iCR) or tibolone	Black Cohosh (iCR) or tibolone	Schaper & Bruemmer GmbH & Co KG	phase 3	Herbal extract / Selective tissue estrogenic activity regulator (STEAR)	Serotonin receptors (Black Cohosh); 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 (Selective tissue estrogenic activity regulator (STEAR); synthetic steroid class)

1. Wyeth is now a wholly owned subsidiary of Pfizer · 1 drug in this class