Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fezolinetant · 2 trials · 2 indications
Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.
Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.
The severity of VMS will be calculated using a weighted average of VMS events.
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Number of participants with potentially clinically significant laboratory values.
Number of participants with potentially clinically significant vital sign values.
Number of participants with potentially clinically significant ECG values.
Area under the concentration-time curve from the time of dosing to 24 hours (AUC24) will be recorded from the pharmacokinetic (PK) plasma samples collected.
AUC from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Percentage of extrapolated section of AUCinf (AUCinf(%extrap)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Concentration immediately prior to dosing at multiple dosing (trough concentration) (Ctrough) will be recorded from the pharmacokinetic (PK) plasma samples collected.
AUC from the time of dosing to the start of the next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Apparent total clearance after extra-vascular dosing (CL/F) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Peak-trough ratio (PTR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Accumulation ratio calculated using AUC (Rac(AUC)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Accumulation ratio calculated using Cmax (Rac(Cmax)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Apparent volume of distribution during the terminal elimination phase after extra-vascular dosing (Vz/F) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time-lag (Tlag) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Area under the concentration-time curve from the time of dosing to 24 hours (AUC24) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Percentage of extrapolated section of AUCinf (AUCinf(%extrap)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Concentration immediately prior to dosing at multiple dosing (trough concentration) (Ctrough) will be recorded from the pharmacokinetic (PK) plasma samples collected.
AUC from the time of dosing to the start of the next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Peak-trough ratio (PTR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Accumulation ratio calculated using AUC (Rac(AUC)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Accumulation ratio calculated using Cmax (Rac(Cmax)) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Metabolite to parent ratio (MPR) will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time-lag (Tlag) will be recorded from the pharmacokinetic (PK) plasma samples collected.
| Arm | Type | Description |
|---|---|---|
| Fezolinetant group | EXPERIMENTAL | Participants will receive fezolinetant once daily for 24 weeks. |
| Placebo group | PLACEBO_COMPARATOR | Participants will receive matching placebo for 12 weeks, and then receive fezolinetant for 12 weeks once daily. |
| fezolinetant | EXPERIMENTAL | A single oral dose of fezolinetant will be administered with water under fasting conditions on day 1 (low dose), day 4 (medium dose) and day 7 (high dose). From day 10 to day 15, the medium dose of fezolinetant will be administered with water after breakfast once daily. On day 16, the medium dose of fezolinetant will be administered with water under fasting conditions. |
| Name | Type | Description |
|---|---|---|
| Fezolinetant | DRUG | Oral |
| Placebo | DRUG | Oral |
Inclusion Criteria: * Participant has a body mass index ≥16 kg/m\^2 and ≤38 kg/m\^2 (extremes included) at screening visit. * Participant must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per 1 of the following criteria at the scr...
Fezolinetant is an investigational small molecule being developed for the treatment of moderate to severe hot flashes in women going through menopause. It is also being studied in healthy volunteers for pharmacokinetic and safety evaluation. The drug is in Phase 3 clinical development for the hot flashes indication.
Fezolinetant is being developed by China Pharma Holdings, Inc. (ticker: CPHI). The company is conducting clinical trials for the drug in Asia, including China, South Korea, and Taiwan.
Fezolinetant is in Phase 3 clinical development for the treatment of moderate to severe hot flashes in menopausal women. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study in healthy volunteers has also been completed.
Fezolinetant has been studied in two completed clinical trials. NCT04234204 is a Phase 3, randomized, double-blind, placebo-controlled study in 302 women aged 40 years and older with hot flashes in China, South Korea, and Taiwan. NCT04793204 is a Phase 1 study in 16 healthy Chinese female subjects.
No alternative names for Fezolinetant have been reported. The drug is identified by its generic name Fezolinetant in clinical trials and development records.