Recent Updates
Recently added Catalysts

FP-101

Phase 2

Hot Flashes | Small molecule | Endocrine |IQVIA Holdings, Inc.|Last Updated: Nov 1, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment109

FDA Designations

No designations recorded

Clinical trial landscape

FP-101 · 1 trial · 1 indication

Phase 2 1
NCT03285672FP-101 for the Treatment of Hot Flashes in Postmenopausal WomenHot Flashes
COMPLETED109 Analytics
PHASE2COMPLETED
FP-101 for the Treatment of Hot Flashes in Postmenopausal Women
Hot Flashes
NCT03285672109
Unlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes.
Baseline to Week 8

Secondary Endpoints

Change in the severity of moderate-to-severe hot flashes.
Baseline to Week 8
Change in the frequency of moderate-to-severe hot flashes.
Baseline to Week 4
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALFP-101
Arm 2PLACEBO_COMPARATORPlacebo Comparator

Interventions

NameTypeDescription
FP-101DRUGDose 1
Placebo ComparatorDRUGDose 1
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: Subjects may be enrolled in the main study only if they meet all of the following criteria: * Subject must be a female \>40 years of age at screening. * Subject must have reported more than 7 to 8 moderate-to-severe hot flashes per day or 50 to 60 hot flashes per week for at le...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about FP-101

What is FP-101 used for?

FP-101 is an investigational small molecule being developed for the treatment of hot flashes in postmenopausal women. It is currently in Phase 2 clinical development for this indication, which falls under the endocrine therapeutic area.

What does FP-101 target?

FP-101 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its ability to treat hot flashes in postmenopausal women, though the exact mechanism of action is not publicly detailed.

Who makes FP-101?

FP-101 is being developed by IQVIA Holdings, Inc., a company publicly traded under the ticker symbol IQV. The drug is currently in Phase 2 clinical development for the treatment of hot flashes.

What phase is FP-101 in?

FP-101 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating hot flashes.

What clinical trials is FP-101 in?

FP-101 has one completed Phase 2 clinical trial, identified by the National Clinical Trial number NCT03285672. This trial, titled "FP-101 for the Treatment of Hot Flashes in Postmenopausal Women," enrolled 109 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is FP-101 the same as any other drug?

FP-101 is not known to be the same as any other drug, as no alternative names have been associated with it. It is a distinct investigational compound being developed by IQVIA Holdings, Inc. for the treatment of hot flashes.