Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 86-5310 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ZK 283197, 3 mg | EXPERIMENTAL | Postmenopausal women with hot flushes received 3 mg (3 x 1 mg tablets) ZK 283197, administered orally once daily over 8 weeks |
| Matching placebo | PLACEBO_COMPARATOR | Postmenopausal women with hot flushes received placebo (3 tablets) orally once daily over 8 weeks |
| ZK 283197, 2 mg | EXPERIMENTAL | Postmenopausal women with hot flushes received 2 mg (2 x 1 mg tablet) ZK 283197 plus 1 placebo tablet, once daily orally over 8 weeks |
| 17ß-estradiol | ACTIVE_COMPARATOR | Postmenopausal women with hot flushes received 1 mg (2 x 0.5 mg tablet) 17ß-estradiol plus 1 placebo tablet, once daily orally over 8 weeks |
| Name | Type | Description |
|---|---|---|
| BAY 86-5310 (ZK 283197) | DRUG | 3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks |
| Placebo | DRUG | Placebo, once daily p.o. over 8 weeks |
| 17ß-estradiol | DRUG | 1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks |
Inclusion Criteria: * Women with at least 35 moderate to severe hot flushes in seven consecutive days * Body mass index (BMI) : 20 - 30 kg/m² (inclusive) * Postmenopausal status Exclusion Criteria: * Contraindication for use for hormonal therapy * Prior hysterectomy * Hormonal therapy or intraute...
BAY 86-5310 is an investigational small molecule being developed for the treatment of vasomotor symptoms, which include hot flashes and night sweats. It is being studied in the therapeutic area of neurology. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
BAY 86-5310 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for vasomotor symptoms.
BAY 86-5310 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug remains investigational and has not received FDA approval. Further clinical studies may be needed to establish its safety and efficacy.
BAY 86-5310 has one completed clinical trial registered as NCT00537836, titled "ZK283197 for Treatment of Vasomotor Symptoms." This Phase 2 study enrolled 116 female participants aged 45 years and older in Germany, Netherlands, and United Kingdom. The trial was randomized, double-blind, and placebo-controlled.
Yes, BAY 86-5310 is also known as ZK283197. The clinical trial NCT00537836 uses the name ZK283197 in its title, referring to the same investigational drug. This alternative name may appear in scientific literature and trial registries.