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Add back therapy 1 (tibolone) — Competitive Intelligence Brief

Add back therapy 1 (tibolone) (Add back therapy 1 (tibolone)) competitive landscape: 5 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Selective Tissue Estrogenic Activity Regulator (STEAR); Hormone Replacement Therapy. Area: Endocrinology; Women's Health.

marketed Selective Tissue Estrogenic Activity Regulator (STEAR); Hormone Replacement Therapy Estrogen receptor, Progesterone receptor, Androgen receptor Endocrinology; Women's Health Small molecule Live · refreshed every 30 min

Target snapshot

Add back therapy 1 (tibolone) (Add back therapy 1 (tibolone)) — University of Cagliari. 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)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Add back therapy 1 (tibolone) TARGET Add back therapy 1 (tibolone) University of Cagliari marketed Selective Tissue Estrogenic Activity Regulator (STEAR); Hormone Replacement Therapy 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
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
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 (Livial) 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
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); Hormone Replacement Therapy class)

  1. University of Cagliari · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Add back therapy 1 (tibolone) — Competitive Intelligence Brief. https://druglandscape.com/ci/add-back-therapy-1-tibolone. Accessed 2026-05-16.

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