Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vilaprisan · 6 trials · 5 indications
Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period.
Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation \[AUC(0-tlast)\], if AUC cannot be estimated in all subjects. In subjects with normal and moderately reduced renal function.
In subjects with normal and moderately reduced renal function.
Exposure of Vilaprisan in plasma following a single dose administration
Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administration
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
| Arm | Type | Description |
|---|---|---|
| Arm 1 - BAY1002670 + BAY1002670 | EXPERIMENTAL | Vilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks) |
| Arm 2 - Placebo + BAY1002670 | EXPERIMENTAL | Placebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks) |
| Arm 3 - BAY1002670 + BAY1002670 | EXPERIMENTAL | Vilaprisan 2 mg once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily (12 weeks) |
| Arm 4 - Placebo+BAY1002670 | EXPERIMENTAL | Placebo once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily(12 weeks) |
| Arm 5 - Ulipristal + Ulipristal | ACTIVE_COMPARATOR | Ulipristal 5 mg once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks) |
| Arm 6- Placebo + Ulipristal | ACTIVE_COMPARATOR | Placebo once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks) |
| Arm 7- Ulipristal + Placebo | ACTIVE_COMPARATOR | Ulipristal 5 mg once daily (12 weeks), treatment break, Placebo once daily (12 weeks) |
| Subjects with moderately decreased renal function | EXPERIMENTAL | Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m\*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. |
| Subjects with severely decreased renal function | EXPERIMENTAL | Subjects with severe renal impairment not on dialysis with an eGFR \<30 mL/min/1.73 m\*2 (CKD-EPI formula). |
| Control subjects with normal renal function | EXPERIMENTAL | Subjects with an eGFR ≥90 mL/min/1.73 m\*2 (CKD-EPI formula) who are matched based on sex, age, race and weight. |
| COC + Vilaprisan | EXPERIMENTAL | COC + Vilaprisan (BAY 1002670) |
| COC + Placebo | PLACEBO_COMPARATOR | COC + Placebo |
| Healthy subjects | EXPERIMENTAL | healthy subjects |
| Subjects with mild hepatic impairment | EXPERIMENTAL | hepatically impaired patients (classified as Child Pugh A) |
| Subjects with moderate hepatic impairment | EXPERIMENTAL | hepatically impaired patients (classified as Child Pugh B) |
| Vilaprisan + Itraconazole | EXPERIMENTAL | Vilaprisan (BAY1002670) |
| Vilaprisan [0.5mg] | EXPERIMENTAL | 0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
| Vilaprisan [1mg] | EXPERIMENTAL | 1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
| Vilaprisan [2mg] | EXPERIMENTAL | 2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
| Vilaprisan [4mg] | EXPERIMENTAL | 4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days |
| Name | Type | Description |
|---|---|---|
| Vilaprisan (BAY1002670) | DRUG | Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks) |
| Vilaprisan (BAY1002670 | DRUG | Placebo (12 weeks),Vilaprisan (12 weeks) |
| Ulipristal | DRUG | Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks) |
| Vilaprisan (BAY 1002670) | DRUG | Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3. |
| Vilaprisan Placebo | DRUG | Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3. |
| Microgynon | DRUG | Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21) |
| Microgynon Placebo | DRUG | For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91). |
| [14C] Vilaprisan | DRUG | an intravenous microtracer dose of \[14C\]Vilaprisan administered together with the 1st single oral dose of Vilaprisan |
| Itraconazole(ITZ) | OTHER | Itraconazole(ITZ) 200 mg as solution, once daily for 14 days |
Inclusion Criteria: * Women, 18 to 50 years of age at the time of screening * Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter \>/=3.0 cm * Heavy menstrual bleeding (HMB) \>80 mL documented by menstrual pic...
Vilaprisan is an investigational small molecule being studied for uterine fibroids, also known as leiomyoma, and endometriosis. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved for any use.
Vilaprisan is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer has sponsored multiple clinical trials of the drug across various countries.
Vilaprisan is in Phase 1 clinical development. While one completed trial was Phase 2, the most advanced ongoing stage is Phase 1, and the drug is still investigational. It has not been approved by regulatory authorities.
Vilaprisan has been studied in several completed trials, including NCT02465814, a Phase 2 safety and efficacy study in patients with uterine fibroids, and NCT03092999, a Phase 1 pharmacokinetic study in hepatic impairment. Other trials include NCT03210246 and NCT03411980.
Vilaprisan is a small molecule that acts as a selective progesterone receptor modulator. It works by modulating the activity of progesterone receptors, which are involved in the growth of uterine fibroids and endometrial tissue, thereby potentially reducing symptoms of these conditions.
Yes, Vilaprisan is also known as BAY1002670. In clinical trial NCT03092999, the drug is referred to as BAY1002670 (Vilaprisan), confirming that these names refer to the same investigational compound.