Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Vilaprisan (BAY 1002670)
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 oral drug being studied for uterine fibroids, also called leiomyomas, and related gynecological conditions. It has been evaluated in Phase 1 and Phase 2 clinical trials, including studies in patients with uterine fibroids and in healthy volunteers with renal or hepatic impairment.
Vilaprisan targets the progesterone receptor, or PGR. It acts as a modulator of this receptor. By binding to PGR, vilaprisan is designed to modulate progesterone signaling, which is relevant to the treatment of uterine fibroids and other progesterone-sensitive conditions.
Vilaprisan is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical trials evaluating vilaprisan in uterine fibroids and related conditions.
Vilaprisan is in Phase 1 clinical development, with completed Phase 1 trials and a completed Phase 2 trial. It is investigational and has not been approved by the FDA for any indication. The Phase 1 studies examined pharmacokinetics and safety in renal impairment, hepatic impairment, and drug-drug interactions.
Vilaprisan has been studied in several completed trials, including NCT03411980, a Phase 1 pharmacokinetics and safety study in renal impairment; NCT03210246, a Phase 1 drug-drug interaction study with a combined oral contraceptive; NCT03092999, a Phase 1 hepatic impairment study; and NCT02465814, a Phase 2 safety and efficacy trial in patients with uterine fibroids.
Yes, Vilaprisan is also known as BAY 1002670 or BAY1002670. These are alternative names for the same investigational compound developed by Bayer. The different names refer to the same drug candidate.