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Black Cohosh (iCR) or tibolone
Black Cohosh (iCR) or tibolone is a Herbal extract / Selective tissue estrogenic activity regulator (STEAR) Small molecule drug developed by Schaper & Bruemmer GmbH & Co KG. It is currently in Phase 3 development for Vasomotor symptoms (hot flashes, night sweats) associated with menopause, Menopausal syndrome.
Black Cohosh (iCR) and tibolone work through different pathways—Black Cohosh may modulate serotonin and other neurotransmitters to reduce vasomotor symptoms, while tibolone acts as a selective tissue estrogenic activity regulator (STEAR) with mixed estrogenic, progestagenic, and androgenic effects.
Black Cohosh (iCR) and tibolone work through different pathways—Black Cohosh may modulate serotonin and other neurotransmitters to reduce vasomotor symptoms, while tibolone acts as a selective tissue estrogenic activity regulator (STEAR) with mixed estrogenic, progestagenic, and androgenic effects. Used for Vasomotor symptoms (hot flashes, night sweats) associated with menopause, Menopausal syndrome.
At a glance
| Generic name | Black Cohosh (iCR) or tibolone |
|---|---|
| Sponsor | Schaper & Bruemmer GmbH & Co KG |
| Drug class | Herbal extract / Selective tissue estrogenic activity regulator (STEAR) |
| Target | Serotonin receptors (Black Cohosh); estrogen receptor, progesterone receptor, androgen receptor (tibolone) |
| Modality | Small molecule |
| Therapeutic area | Women's Health / Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Black Cohosh is a phytoestrogen-containing herbal extract that may reduce hot flashes and night sweats through serotonergic mechanisms and possible weak estrogen receptor modulation. Tibolone is a synthetic steroid that selectively activates estrogen, progesterone, and androgen receptors in a tissue-specific manner, providing menopausal symptom relief while potentially minimizing systemic hormonal exposure. The combination or comparison in this Phase 3 trial likely evaluates efficacy and safety profiles for menopausal symptom management.
Approved indications
- Vasomotor symptoms (hot flashes, night sweats) associated with menopause
- Menopausal syndrome
Common side effects
- Headache
- Gastrointestinal upset
- Vaginal bleeding or spotting
- Breast tenderness
- Dizziness
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Black Cohosh (iCR) or tibolone CI brief — competitive landscape report
- Black Cohosh (iCR) or tibolone updates RSS · CI watch RSS
- Schaper & Bruemmer GmbH & Co KG portfolio CI
Frequently asked questions about Black Cohosh (iCR) or tibolone
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Related
- Drug class: All Herbal extract / Selective tissue estrogenic activity regulator (STEAR) drugs
- Target: All drugs targeting Serotonin receptors (Black Cohosh); estrogen receptor, progesterone receptor, androgen receptor (tibolone)
- Manufacturer: Schaper & Bruemmer GmbH & Co KG — full pipeline
- Therapeutic area: All drugs in Women's Health / Endocrinology
- Indication: Drugs for Vasomotor symptoms (hot flashes, night sweats) associated with menopause
- Indication: Drugs for Menopausal syndrome
- Compare: Black Cohosh (iCR) or tibolone vs similar drugs
- Pricing: Black Cohosh (iCR) or tibolone cost, discount & access